NCT03483103 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
- id
- FG000
- title
- Lisocabtagene Maraleucel (JCAR017)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- No longer meets eligibility criteria
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Disease-related complications
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 74
- comment
- Participants who underwent leukapheresis
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 63
- comment
- Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Pre-Treatment Phase
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 23
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Did not receive either JAR017 or nonconforming product
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Received nonconforming product
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 63
- comment
- Participants who underwent lymphodepleting chemotherapy (LDC) treatment
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 61
- type
- Received JCAR017
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Received Nonconforming Product
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Did Not Receive Either JAR017 or Nonconforming Product
- achievements
- group Id
- FG000
- num Subjects
- 30
- comment
- Completed study
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- NOT COMPLETED
- title
- Treatment Phase
- pre Assignment Details
- All efficacy and safety analyses were conducted on the JCAR017-treated Analysis Set.
Complete source fields
- groups
- description
- Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
- id
- FG000
- title
- Lisocabtagene Maraleucel (JCAR017)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- No longer meets eligibility criteria
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Disease-related complications
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 74
- comment
- Participants who underwent leukapheresis
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 63
- comment
- Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Pre-Treatment Phase
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 23
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Did not receive either JAR017 or nonconforming product
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Received nonconforming product
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 63
- comment
- Participants who underwent lymphodepleting chemotherapy (LDC) treatment
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 61
- type
- Received JCAR017
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Received Nonconforming Product
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Did Not Receive Either JAR017 or Nonconforming Product
- achievements
- group Id
- FG000
- num Subjects
- 30
- comment
- Completed study
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- NOT COMPLETED
- title
- Treatment Phase
- pre Assignment Details
- All efficacy and safety analyses were conducted on the JCAR017-treated Analysis Set.
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