NCT03575351 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
- id
- FG000
- title
- Standard of Care Arm
- description
- \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
- id
- FG001
- title
- Liso-cel Arm
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Death due to the COVID-19 pandemic
- reasons
- group Id
- FG000
- num Subjects
- 28
- group Id
- FG001
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 6
- type
- Disease relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Study drug manufacturing failure
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 0
- type
- other reasons
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 92
- comment
- Received lymphodepleting chemotherapy (LDC)
- group Id
- FG001
- num Subjects
- 92
- comment
- Randomized
- type
- STARTED
- achievements
- comment
- SOC Treatment
- group Id
- FG000
- num Subjects
- 91
- comment
- Liso-cel Treatment
- group Id
- FG001
- num Subjects
- 90
- type
- Treated
- achievements
- group Id
- FG000
- num Subjects
- 61
- group Id
- FG001
- num Subjects
- 0
- comment
- Received SOC but were eligible to receive JCAR017 treatment
- type
- Crossover
- achievements
- group Id
- FG000
- num Subjects
- 57
- group Id
- FG001
- num Subjects
- 89
- type
- Received JCAR017 Conforming Cell Product
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Received JCAR017 Nonconforming Cell Product
- achievements
- group Id
- FG000
- num Subjects
- 37
- group Id
- FG001
- num Subjects
- 81
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 55
- group Id
- FG001
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
- id
- FG000
- title
- Standard of Care Arm
- description
- \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
- id
- FG001
- title
- Liso-cel Arm
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Death due to the COVID-19 pandemic
- reasons
- group Id
- FG000
- num Subjects
- 28
- group Id
- FG001
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 6
- type
- Disease relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Study drug manufacturing failure
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 0
- type
- other reasons
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 92
- comment
- Received lymphodepleting chemotherapy (LDC)
- group Id
- FG001
- num Subjects
- 92
- comment
- Randomized
- type
- STARTED
- achievements
- comment
- SOC Treatment
- group Id
- FG000
- num Subjects
- 91
- comment
- Liso-cel Treatment
- group Id
- FG001
- num Subjects
- 90
- type
- Treated
- achievements
- group Id
- FG000
- num Subjects
- 61
- group Id
- FG001
- num Subjects
- 0
- comment
- Received SOC but were eligible to receive JCAR017 treatment
- type
- Crossover
- achievements
- group Id
- FG000
- num Subjects
- 57
- group Id
- FG001
- num Subjects
- 89
- type
- Received JCAR017 Conforming Cell Product
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Received JCAR017 Nonconforming Cell Product
- achievements
- group Id
- FG000
- num Subjects
- 37
- group Id
- FG001
- num Subjects
- 81
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 55
- group Id
- FG001
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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