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NCT03483103 · FLOW

Participant flow

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

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

groups
  1. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      No longer meets eligibility criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease-related complications
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      comment
      Participants who underwent leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        63
      comment
      Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Pre-Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        23
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not receive either JAR017 or nonconforming product
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Received nonconforming product
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        63
      comment
      Participants who underwent lymphodepleting chemotherapy (LDC) treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      Received JCAR017
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Received Nonconforming Product
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Did Not Receive Either JAR017 or Nonconforming Product
    5. achievements
      1. group Id
        FG000
        num Subjects
        30
      comment
      Completed study
      type
      COMPLETED
    6. achievements
      1. 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
  1. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      No longer meets eligibility criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease-related complications
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      comment
      Participants who underwent leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        63
      comment
      Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Pre-Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        23
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not receive either JAR017 or nonconforming product
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Received nonconforming product
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        63
      comment
      Participants who underwent lymphodepleting chemotherapy (LDC) treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      Received JCAR017
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Received Nonconforming Product
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Did Not Receive Either JAR017 or Nonconforming Product
    5. achievements
      1. group Id
        FG000
        num Subjects
        30
      comment
      Completed study
      type
      COMPLETED
    6. achievements
      1. 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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Preserved source evidence · Not medical advice