Trial Outcomes & Findings for Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI... (NCT NCT01319565)
NCT ID: NCT01319565
Last Updated: 2025-12-19
Results Overview
Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months).
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1X: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
Arm 1X: Compassionate Exemption. Participant received young tumor infiltrating lymphocytes (TIL) and Interleukin-2 (IL-2), but not cyclophosphamide or fludarabine (they were administered before the participant enrolled onto this protocol).
Young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
1
|
|
Overall Study
COMPLETED
|
51
|
48
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1X: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
Arm 1X: Compassionate Exemption. Participant received young tumor infiltrating lymphocytes (TIL) and Interleukin-2 (IL-2), but not cyclophosphamide or fludarabine (they were administered before the participant enrolled onto this protocol).
Young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|
|
Overall Study
Not treated: Rapid disease progression prior to start
|
0
|
2
|
0
|
Baseline Characteristics
Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI...
Baseline characteristics by cohort
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=50 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=8 Participants
|
50 Participants
n=6 Participants
|
100 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Age, Continuous
|
46.0 years
n=8 Participants
|
47.1 years
n=6 Participants
|
47.0 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=8 Participants
|
20 Participants
n=6 Participants
|
37 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=8 Participants
|
30 Participants
n=6 Participants
|
64 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
50 Participants
n=8 Participants
|
49 Participants
n=6 Participants
|
99 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=8 Participants
|
46 Participants
n=6 Participants
|
96 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race Unknown or Not Reported
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=8 Participants
|
50 participants
n=6 Participants
|
101 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months).Population: 99/102 participants were analyzed. Two participants were not treated due to rapidly progressive disease after enrollment but before treatment. One participant on Arm 1X is not reported for privacy concerns (n=1).
Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Fludarabine
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Complete Response
|
27.5 Percentage of participants
|
27.1 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Partial Response
|
19.6 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Stable Disease
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Progressive Disease
|
52.9 Percentage of participants
|
35.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Participants were followed from treatment until death (median 14 months) or until principal investigator (PI) discretion (median 99.0 months) for participants alive at study closure.Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1).
OS is defined as the time to death following the start of treatment.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
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Arm 2: Fludarabine
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Survival (OS)
|
36.2 Months
Interval 1.2 to 158.3
|
37.3 Months
Interval 2.5 to 138.6
|
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—
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—
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—
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SECONDARY outcome
Timeframe: Participants were followed from treatment until death or until principal investigator (PI) discretion. A median of 91.8 months.Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1).
PFS is defined as time to disease progression following the start of treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v3.0. Progressive Disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Fludarabine
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|---|---|---|---|---|---|---|
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Progression-free Survival (PFS)
|
6.8 Months
Interval 1.1 to 158.2
|
9.3 Months
Interval 0.5 to 109.9
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Time of registration through 6 years after the last treatment.Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
Here is the number of Grades 2, 3, 4, and/or 5 serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
n=51 Participants
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
n=51 Participants
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Fludarabine
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Dyspnea (shortness of breath)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - left ventricular diastolic dysfunction
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Neurology - Other Specify, hydrocephalus
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Renal failure
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Renal failure
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Any Grade 5 possibly and/or probably related
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Any Grade 1 possibly and/or probably related
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Anorexia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Anorexia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Calcium, serum low (hypocalcemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Creatinine
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Creatinine
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pleural effusion (non-malignant)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
12 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Hemoglobin
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
SECONDARY outcome
Timeframe: 30 days after end of treatment, up to 6 yearsPopulation: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
Here is the number of Grades 1, 2, 3, 4, and/or 5 non-serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
n=51 Participants
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
n=51 Participants
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Fludarabine
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
n=48 Participants
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 probably related - Confusion
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 possibly related - Diarrhea
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Creatinine
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Uveitis
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Vision-blurred vision
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Anorexia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Febrile neutropenia
|
0 adverse events
|
0 adverse events
|
23 adverse events
|
23 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
35 adverse events
|
35 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Lymphopenia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Lymphopenia
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Nausea
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
3 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Nausea
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
3 adverse events
|
0 adverse events
|
4 adverse events
|
9 adverse events
|
9 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Platelets
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Renal failure
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Retinopathy
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Rigors/chills
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Syncope (fainting)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 probably related - Mood alteration::Agitation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 probably related - Dyspnea (shortness of breath)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 Fatigue (asthenia, lethargy, malaise)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 possibly related - Hypopigmentation
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 probably related - Hypopigmentation
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 Pain::Chest wall
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Acute vascular leak syndrome
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Confusion
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Creatinine
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Diarrhea
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Dry mouth/salivary gland (xerostomia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Dyspnea (shortness of breath)
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Dyspnea (shortness of breath)
|
13 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
12 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Fatigue
|
1 adverse events
|
0 adverse events
|
10 adverse events
|
10 adverse events
|
1 adverse events
|
0 adverse events
|
6 adverse events
|
6 adverse events
|
6 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Hemorrhage, GU:: Bladder
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 - possibly related - hypopigmentation
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 - probably related - hypopigmentation
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Hypotension
|
7 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Hypoxia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Mental status
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Mood alteration::Agitation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Neuropathy:sensory
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Psychosis (hallucinations/delusions)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Rash/desquamation
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output)
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Rigors/chills
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 probably related - Somnolence/depressed level of consciousness
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Acidosis (metabolic or respiratory)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Acute vascular leak syndrome
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Acute vascular leak syndrome
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia)
|
1 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Albumin, serum-low (hypoalbuminemia)
|
1 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Alkaline phosphatase
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Cardiac troponin I (cTnl)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Bilirubin (hyperbilirubinemia)
|
1 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Calcium, serum low (hypocalcemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Calcium, serum low (hypocalcemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Creatinine
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Diarrhea
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Dry mouth/salivary gland (xerostomia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Dry mouth/salivary gland (xerostomia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Dyspnea (shortness of breath)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Dyspnea (shortness of breath)
|
9 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
5 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Edema: head and neck
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise)
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
5 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Fatigue (asthenia, lethargy, malaise)
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
0 adverse events
|
1 adverse events
|
4 adverse events
|
4 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Febrile neutropenia
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Fever
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Fever
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Hemoglobin
|
12 adverse events
|
0 adverse events
|
9 adverse events
|
9 adverse events
|
13 adverse events
|
0 adverse events
|
12 adverse events
|
16 adverse events
|
16 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Hemoglobin
|
0 adverse events
|
0 adverse events
|
13 adverse events
|
13 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
18 adverse events
|
18 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Hemorrhage, GI::Ileum
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Hemorrhage, GI::Ileum
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Hypotension
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Hypoxia
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Hypoxia
|
10 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
10 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Leukocytes (total WBC)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Leukocytes (total WBC)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Mental status
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
4 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Abdomen NOS
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Pain::Abdomen NOS
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Pain::Bladder
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Chest/thorax NOS
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Head/headache
|
3 adverse events
|
0 adverse events
|
7 adverse events
|
7 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Joint
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Muscle
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pain::Pain NOS
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia)
|
4 adverse events
|
0 adverse events
|
10 adverse events
|
10 adverse events
|
11 adverse events
|
0 adverse events
|
2 adverse events
|
12 adverse events
|
12 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Phosphate, serum-low (hypophosphatemia)
|
1 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
3 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pleural effusion
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Pneumonitis/pulmonary infiltrates
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Pneumonitis/pulmonary infiltrates
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Potassium, serum-low (hypokalemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Potassium, serum-low (hypokalemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Psychosis
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - PTT (Partial Thromboplastin Time)
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - PTT (Partial Thromboplastin Time)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Rash/desquamation
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Rash/desquamation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Renal failure
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Rigors/chills
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Sodium, serum-low (hyponatremia)
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Syncope (fainting)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Thrombotic microangiopathy
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
5 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 possibly related - Vomiting
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 3 probably related - Vomiting
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Bilirubin (hyperbilirubinemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Calcium, serum-low (hypocalcemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Calcium, serum-low (hypocalcemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Febrile neutropenia
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Hypotension
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Leukocytes (total WBC)
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
13 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Leukocytes (total WBC)
|
0 adverse events
|
0 adverse events
|
50 adverse events
|
50 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
48 adverse events
|
48 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Lymphopenia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Lymphopenia
|
0 adverse events
|
0 adverse events
|
51 adverse events
|
51 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
48 adverse events
|
48 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC)
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
11 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC)
|
0 adverse events
|
0 adverse events
|
50 adverse events
|
50 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
46 adverse events
|
46 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Phosphate, serum-low (hypophosphatemia)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Platelets
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
15 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably related - Platelets
|
0 adverse events
|
0 adverse events
|
39 adverse events
|
39 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
39 adverse events
|
39 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 possibly related - Potassium, serum-low (hypokalemia)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed for adverse events from registration through 30 days after the last treatment, up to 6 yearsPopulation: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 Participants
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 1: Related to Fludarabine
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 1: Related to Cyclophosphamide
Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Related to Interleukin-2 (IL-2)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Tumor Infiltrating Lymphocytes
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Total Body Irradiation (TBI)
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Fludarabine
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
Arm 2: Related to Cyclophosphamide
Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0)
|
51 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
Serious events: 2 serious events
Other events: 51 other events
Deaths: 23 deaths
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
Serious events: 17 serious events
Other events: 48 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 participants at risk
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 participants at risk
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Death not associated with CTCAE term::Disease progression NOS
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Neurology - Other (Specify, __): HYDROCEPHALUS
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
16.7%
8/48 • Number of events 8 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
Other adverse events
| Measure |
Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2)
n=51 participants at risk
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
|
Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI)
n=48 participants at risk
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
8.3%
4/48 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
7.8%
4/51 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Vascular disorders
Acute vascular leak syndrome
|
5.9%
3/51 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
7.8%
4/51 • Number of events 6 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
25.0%
12/48 • Number of events 12 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
14.6%
7/48 • Number of events 8 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Confusion
|
5.9%
3/51 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Creatinine
|
7.8%
4/51 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
10.4%
5/48 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
10.4%
5/48 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
47.1%
24/51 • Number of events 24 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
37.5%
18/48 • Number of events 20 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
17/51 • Number of events 17 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
29.2%
14/48 • Number of events 14 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Febrile neutropenia
|
51.0%
26/51 • Number of events 26 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
75.0%
36/48 • Number of events 38 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
39.2%
20/51 • Number of events 22 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
64.6%
31/48 • Number of events 35 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Ileum
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Hemorrhage, GU::Bladder
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
15.7%
8/51 • Number of events 8 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Hypotension
|
19.6%
10/51 • Number of events 10 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
18.8%
9/48 • Number of events 9 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
23.5%
12/51 • Number of events 12 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
22.9%
11/48 • Number of events 12 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Incontinence, urinary
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Infections and infestations
Infection with unknown ANC::Nerve-peripheral
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
51/51 • Number of events 51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
100.0%
48/48 • Number of events 49 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
51/51 • Number of events 55 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
100.0%
48/48 • Number of events 50 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Mental status
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Mood alteration::Agitation
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
18.8%
9/48 • Number of events 9 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Neuropathy: sensory
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
51/51 • Number of events 51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
100.0%
48/48 • Number of events 48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __): Corneal Edema, OU
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __): VISION CHANGES (R EYE)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Pain::Bladder
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Reproductive system and breast disorders
Pain::Breast
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest/thorax NOS
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain::Face
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Pain::Head/headache
|
13.7%
7/51 • Number of events 7 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Pain::Neuralgia/peripheral nerve
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Sinus
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Pain::Tumor pain
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
25.5%
13/51 • Number of events 15 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
31.2%
15/48 • Number of events 18 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Platelets
|
78.4%
40/51 • Number of events 40 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
81.2%
39/48 • Number of events 40 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
10.4%
5/48 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
9.8%
5/51 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
14.6%
7/48 • Number of events 7 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.8%
5/51 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __): Low urine output
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __): Low urine output (nonoliguric renal insufficiency)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __): Lower urine output
|
5.9%
3/51 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __): Oliguria
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __): low urine output
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Retinopathy
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
General disorders
Rigors/chills
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
3.9%
2/51 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
8.3%
4/48 • Number of events 4 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
6.2%
3/48 • Number of events 3 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
10.4%
5/48 • Number of events 5 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Uveitis
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia::Ventricular tachycardia
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
2.1%
1/48 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Eye disorders
Vision-flashing lights/floaters
|
2.0%
1/51 • Number of events 1 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
0.00%
0/48 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
4.2%
2/48 • Number of events 2 • All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place