Trial Outcomes & Findings for Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma (NCT NCT00001832)
NCT ID: NCT00001832
Last Updated: 2012-12-21
Results Overview
Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Every three to four weeks after the treatment, for up to 5 years.
Results posted on
2012-12-21
Participant Flow
Participant milestones
| Measure |
Abl Cells in Culture
Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
|
Abl Cells IV + Cyclophosphamide 30 mg/kg
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apheresis Period
STARTED
|
170
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Apheresis Period
COMPLETED
|
110
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Apheresis Period
NOT COMPLETED
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
3
|
3
|
3
|
6
|
51
|
4
|
7
|
8
|
6
|
1
|
7
|
6
|
3
|
2
|
|
Treatment Period
COMPLETED
|
0
|
3
|
3
|
3
|
6
|
50
|
4
|
6
|
8
|
6
|
1
|
7
|
6
|
3
|
2
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Abl Cells in Culture
Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
|
Abl Cells IV + Cyclophosphamide 30 mg/kg
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apheresis Period
not able to manufacture treatment cells
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Death during treatment
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Cells IV + Cyclophosphamide 30mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
|
Cells IV + Cyclophosphamide 60mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
|
Cells IV + Low-Dose IV IL-2 (Initial)
n=3 Participants
Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Cells IV + High-Dose IV IL-2 (Initial)
n=6 Participants
Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Cells IV + MTD IL-2
n=51 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
|
Cells IA + MTD IL-2 (Prior Cells IV on 6)
n=4 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
|
Cells IA + MTD IL-2
n=7 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
|
Cells IA + MTD IL-2 (MART-1 Reactive)
n=8 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Cells IV + MTD IL-2 no GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Cells IV + MTD IL-2 no GCSF (gp100 Reactive)
n=1 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)
n=7 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Cells IV + SQ IL-2 w/GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
|
Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)
n=3 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Cells IV + SQ IL-2 w/GCSF (no Reactivity)
n=2 Participants
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
|
Total
n=110 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
108 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Age Continuous
|
41.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
41.9 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
38.0 years
STANDARD_DEVIATION 14.3 • n=8 Participants
|
39.7 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
41.8 years
STANDARD_DEVIATION 11.6 • n=24 Participants
|
49.0 years
STANDARD_DEVIATION 10.3 • n=42 Participants
|
62.0 years
n=42 Participants
|
40.7 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
44.2 years
STANDARD_DEVIATION 11.2 • n=42 Participants
|
37.7 years
STANDARD_DEVIATION 7.1 • n=36 Participants
|
58.5 years
STANDARD_DEVIATION 10.6 • n=36 Participants
|
45.0 years
STANDARD_DEVIATION 11.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
38 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
72 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
106 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
109 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
51 participants
n=21 Participants
|
4 participants
n=8 Participants
|
7 participants
n=8 Participants
|
8 participants
n=24 Participants
|
6 participants
n=42 Participants
|
1 participants
n=42 Participants
|
7 participants
n=42 Participants
|
6 participants
n=42 Participants
|
3 participants
n=36 Participants
|
2 participants
n=36 Participants
|
110 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Every three to four weeks after the treatment, for up to 5 years.Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.
Outcome measures
| Measure |
Abl Cells IV + Cyclophosphamide 30 mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
n=3 Participants
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
n=6 Participants
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
n=50 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
n=4 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
n=6 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
n=8 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
n=1 Participants
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
n=7 Participants
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
n=3 Participants
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
n=2 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Response
Progressive Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
No Response
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
32 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Clinical Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Response
Minor Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Mixed Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10.5 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Abl Cells IV + Cyclophosphamide 30 mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
n=3 Participants
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
n=3 Participants
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
n=6 Participants
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
n=51 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
n=4 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
n=7 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
n=8 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
n=1 Participants
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
n=7 Participants
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
n=6 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
n=3 Participants
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
n=2 Participants
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
50 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Abl Cells IV + Cyclophosphamide 30 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Abl Cells IV + Cyclophosphamide 60 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Abl Cells IV+Low Dose IV IL-2 (Initial)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Abl Cells IV+High Dose IV IL-2 (Initial)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Abl Cells IV + MTD IL-2
Serious events: 9 serious events
Other events: 50 other events
Deaths: 0 deaths
Abl Cells IA + MTD (Prior Cells IV on 6)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Abl Cells IA + MTD IL-2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Abl Cells IV + MTD IL-2 no GCSF
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Abl Cells IV + SQ IL-2 With GCSF
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abl Cells IV + Cyclophosphamide 30 mg/kg
n=3 participants at risk
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
n=3 participants at risk
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
n=3 participants at risk
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
n=6 participants at risk
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
n=51 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
n=4 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
n=7 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
n=8 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
n=6 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
n=1 participants at risk
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
n=7 participants at risk
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
n=6 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
n=3 participants at risk
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
n=2 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
General symptom
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Infection/Febrile neutropenia (infection without neutropenia)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Confusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Vascular disorders
Peripheral ischemia
|
—
0/0
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Cardiac disorders
left ventricular dysfunction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0
|
—
0/0
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Abl Cells IV + Cyclophosphamide 30 mg/kg
n=3 participants at risk
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
|
Abl Cells IV + Cyclophosphamide 60 mg/kg
n=3 participants at risk
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
|
Abl Cells IV+Low Dose IV IL-2 (Initial)
n=3 participants at risk
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
|
Abl Cells IV+High Dose IV IL-2 (Initial)
n=6 participants at risk
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
|
Abl Cells IV + MTD IL-2
n=51 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
|
Abl Cells IA + MTD (Prior Cells IV on 6)
n=4 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
|
Abl Cells IA + MTD IL-2
n=7 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
|
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
n=8 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + MTD IL-2 no GCSF
n=6 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
|
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
n=1 participants at risk
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
|
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
n=7 participants at risk
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF
n=6 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
|
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
n=3 participants at risk
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
|
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
n=2 participants at risk
Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 4
|
100.0%
3/3 • Number of events 4
|
66.7%
4/6 • Number of events 5
|
72.5%
37/51 • Number of events 50
|
75.0%
3/4 • Number of events 3
|
71.4%
5/7 • Number of events 8
|
75.0%
6/8 • Number of events 9
|
33.3%
2/6 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
71.4%
5/7 • Number of events 10
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 4
|
100.0%
6/6 • Number of events 7
|
98.0%
50/51 • Number of events 66
|
100.0%
4/4 • Number of events 4
|
71.4%
5/7 • Number of events 8
|
87.5%
7/8 • Number of events 12
|
100.0%
6/6 • Number of events 9
|
100.0%
1/1 • Number of events 1
|
100.0%
7/7 • Number of events 9
|
100.0%
6/6 • Number of events 7
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 4
|
100.0%
3/3 • Number of events 4
|
100.0%
3/3 • Number of events 6
|
83.3%
5/6 • Number of events 9
|
98.0%
50/51 • Number of events 80
|
75.0%
3/4 • Number of events 4
|
85.7%
6/7 • Number of events 12
|
100.0%
8/8 • Number of events 19
|
83.3%
5/6 • Number of events 12
|
100.0%
1/1 • Number of events 1
|
100.0%
7/7 • Number of events 13
|
100.0%
6/6 • Number of events 10
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
100.0%
6/6 • Number of events 7
|
98.0%
50/51 • Number of events 70
|
100.0%
4/4 • Number of events 4
|
71.4%
5/7 • Number of events 10
|
87.5%
7/8 • Number of events 11
|
100.0%
6/6 • Number of events 8
|
100.0%
1/1 • Number of events 1
|
100.0%
7/7 • Number of events 8
|
100.0%
6/6 • Number of events 8
|
100.0%
3/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
31.4%
16/51 • Number of events 19
|
25.0%
1/4 • Number of events 1
|
42.9%
3/7 • Number of events 4
|
75.0%
6/8 • Number of events 6
|
50.0%
3/6 • Number of events 3
|
0.00%
0/1
|
42.9%
3/7 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
31.4%
16/51 • Number of events 17
|
25.0%
1/4 • Number of events 1
|
28.6%
2/7 • Number of events 4
|
50.0%
4/8 • Number of events 4
|
33.3%
2/6 • Number of events 3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
17.6%
9/51 • Number of events 11
|
25.0%
1/4 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
50.0%
4/8 • Number of events 4
|
0.00%
0/6
|
0.00%
0/1
|
42.9%
3/7 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
21.6%
11/51 • Number of events 12
|
0.00%
0/4
|
57.1%
4/7 • Number of events 4
|
50.0%
4/8 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/1
|
28.6%
2/7 • Number of events 5
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
39.2%
20/51 • Number of events 26
|
25.0%
1/4 • Number of events 1
|
28.6%
2/7 • Number of events 6
|
50.0%
4/8 • Number of events 6
|
0.00%
0/6
|
0.00%
0/1
|
71.4%
5/7 • Number of events 8
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
45.1%
23/51 • Number of events 27
|
25.0%
1/4 • Number of events 1
|
85.7%
6/7 • Number of events 9
|
62.5%
5/8 • Number of events 5
|
33.3%
2/6 • Number of events 3
|
0.00%
0/1
|
57.1%
4/7 • Number of events 5
|
100.0%
6/6 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
100.0%
2/2 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.9%
3/51 • Number of events 3
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.9%
3/51 • Number of events 3
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
INR increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.9%
3/51 • Number of events 3
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
66.7%
4/6 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
9.8%
5/51 • Number of events 5
|
0.00%
0/4
|
42.9%
3/7 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.9%
2/51 • Number of events 2
|
0.00%
0/4
|
28.6%
2/7 • Number of events 3
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
66.7%
4/6 • Number of events 5
|
0.00%
0/3
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
7.8%
4/51 • Number of events 4
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
7.8%
4/51 • Number of events 6
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
9.8%
5/51 • Number of events 6
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
9.8%
5/51 • Number of events 5
|
0.00%
0/4
|
0.00%
0/7
|
37.5%
3/8 • Number of events 3
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
17/51 • Number of events 18
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Wound infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
17.6%
9/51 • Number of events 9
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Lipase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
21.6%
11/51 • Number of events 11
|
0.00%
0/4
|
0.00%
0/7
|
25.0%
2/8 • Number of events 5
|
0.00%
0/6
|
0.00%
0/1
|
28.6%
2/7 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
15.7%
8/51 • Number of events 10
|
25.0%
1/4 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
19.6%
10/51 • Number of events 15
|
0.00%
0/4
|
14.3%
1/7 • Number of events 7
|
37.5%
3/8 • Number of events 5
|
33.3%
2/6 • Number of events 4
|
0.00%
0/1
|
14.3%
1/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Confusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
9.8%
5/51 • Number of events 5
|
0.00%
0/4
|
0.00%
0/7
|
37.5%
3/8 • Number of events 3
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
28.6%
2/7 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.9%
2/51 • Number of events 2
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
15.7%
8/51 • Number of events 9
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.9%
2/51 • Number of events 2
|
0.00%
0/4
|
14.3%
1/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.0%
1/51 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Weight loss
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Catheter-related infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Weight gain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Petechiae
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Renal and urinary disorders
Low urine output
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
7.8%
4/51 • Number of events 4
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
General symptom
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Psychosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/51
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
Additional Information
Steven A. Rosenberg, M.D.
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