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NCT03575351 · FLOW

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A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. 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
  2. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death due to the COVID-19 pandemic
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      Disease relapse
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study drug manufacturing failure
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. comment
        Received lymphodepleting chemotherapy (LDC)
        group Id
        FG001
        num Subjects
        92
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. comment
        SOC Treatment
        group Id
        FG000
        num Subjects
        91
      2. comment
        Liso-cel Treatment
        group Id
        FG001
        num Subjects
        90
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      comment
      Received SOC but were eligible to receive JCAR017 treatment
      type
      Crossover
    4. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        89
      type
      Received JCAR017 Conforming Cell Product
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Received JCAR017 Nonconforming Cell Product
    6. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        81
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. 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
  2. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death due to the COVID-19 pandemic
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      Disease relapse
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study drug manufacturing failure
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. comment
        Received lymphodepleting chemotherapy (LDC)
        group Id
        FG001
        num Subjects
        92
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. comment
        SOC Treatment
        group Id
        FG000
        num Subjects
        91
      2. comment
        Liso-cel Treatment
        group Id
        FG001
        num Subjects
        90
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      comment
      Received SOC but were eligible to receive JCAR017 treatment
      type
      Crossover
    4. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        89
      type
      Received JCAR017 Conforming Cell Product
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Received JCAR017 Nonconforming Cell Product
    6. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        81
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice