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NCT01979536 · FLOW

Participant flow

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma · Source last updated 2024-04-30

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

groups
  1. description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    FG000
    title
    Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
  2. description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    FG001
    title
    Arm CZ (Crizotinib, Combination Chemotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Refusal
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Did not start treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        61
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    FG000
    title
    Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
  2. description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    FG001
    title
    Arm CZ (Crizotinib, Combination Chemotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Refusal
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Did not start treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        61
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice