Trial Outcomes & Findings for Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M... (NCT NCT01118091)
NCT ID: NCT01118091
Last Updated: 2015-10-08
Results Overview
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the 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 reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3 years
Results posted on
2015-10-08
Participant Flow
Participant milestones
| Measure |
Arm 1 - Aldesleukin
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M...
Baseline characteristics by cohort
| Measure |
Arm 1 - Aldesleukin
n=7 Participants
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
n=5 Participants
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
49.15 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsResponse was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the 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 reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Arm 1 - Aldesleukin
n=7 Participants
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
n=5 Participants
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
|---|---|---|
|
Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
|
Response Rate
Partial Response
|
1 Participants
|
1 Participants
|
|
Response Rate
Progressive Disease
|
6 Participants
|
4 Participants
|
|
Response Rate
Stable Disease
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 yearsMeasured from the time of randomization to time of progression (or death).
Outcome measures
| Measure |
Arm 1 - Aldesleukin
n=7 Participants
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
n=5 Participants
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
|---|---|---|
|
Progression Free Survival
Patient 2
|
0 Days
|
130 Days
|
|
Progression Free Survival
Patient 1
|
307 Days
|
0 Days
|
|
Progression Free Survival
Patient 3
|
0 Days
|
88 Days
|
|
Progression Free Survival
Patient 4
|
0 Days
|
174 Days
|
|
Progression Free Survival
Patient 5
|
54 Days
|
0 Days
|
|
Progression Free Survival
Patient 6
|
0 Days
|
88 Days
|
|
Progression Free Survival
Patient 7
|
129 Days
|
0 Days
|
|
Progression Free Survival
Patient 8
|
0 Days
|
515 Days
|
|
Progression Free Survival
Patient 9
|
117 Days
|
0 Days
|
|
Progression Free Survival
Patient 10
|
279 Days
|
0 Days
|
|
Progression Free Survival
Patient 11
|
58 Days
|
0 Days
|
|
Progression Free Survival
Patient 12
|
130 Days
|
0 Days
|
SECONDARY outcome
Timeframe: 3 yearsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Arm 1 - Aldesleukin
n=7 Participants
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
n=5 Participants
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
|---|---|---|
|
Toxicity
|
7 Participants
|
5 Participants
|
Adverse Events
Arm 1 - Aldesleukin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 2 - Adoptive Cell Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Aldesleukin
n=7 participants at risk
Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
|
Arm 2 - Adoptive Cell Therapy
n=5 participants at risk
Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10\^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to 2x10\^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10\^8) and the administration of high-dose aldesleukin.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
85.7%
6/7 • Number of events 6
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
85.7%
6/7 • Number of events 7
|
100.0%
5/5 • Number of events 7
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7
|
20.0%
1/5 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/7
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
28.6%
2/7 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
Acute vascular leak syndrome
|
14.3%
1/7 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
85.7%
6/7 • Number of events 6
|
0.00%
0/5
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
42.9%
3/7 • Number of events 4
|
0.00%
0/5
|
|
General disorders
Pain
|
42.9%
3/7 • Number of events 5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
71.4%
5/7 • Number of events 5
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
57.1%
4/7 • Number of events 4
|
0.00%
0/5
|
|
Cardiac disorders
Cardiac arrhythmia - Other, Specify,
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
42.9%
3/7 • Number of events 3
|
0.00%
0/5
|
|
General disorders
Hypothermia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
|
Nervous system disorders
Neuropathy-sensory
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Eye disorders
Uveitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Neutrophilis/granulocytes (ANC/AGC)
|
71.4%
5/7 • Number of events 5
|
0.00%
0/5
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin with
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
Additional Information
Dr. Steven Rosenberg
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place