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NCT00703820 · FLOW

Participant flow

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-10

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

groups
  1. description
    Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    FG000
    title
    Cytarabine+Daunorubicin+Etoposide
  2. description
    Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    FG001
    title
    Clofarabine+Cytarabine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        17
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Received non-protocol therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        129
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        95
      comment
      "For purposes of this report, a living subject \*completes\* the study three years after completion of therapy and the study is considered \*complete\* when all participants have died, been taken off study, or completed the study."
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.
recruitment Details
324 participants enrolled between August 2008 and March 2017.
Complete source fields
groups
  1. description
    Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    FG000
    title
    Cytarabine+Daunorubicin+Etoposide
  2. description
    Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    FG001
    title
    Clofarabine+Cytarabine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        17
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Received non-protocol therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        129
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        95
      comment
      "For purposes of this report, a living subject \*completes\* the study three years after completion of therapy and the study is considered \*complete\* when all participants have died, been taken off study, or completed the study."
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.
recruitment Details
324 participants enrolled between August 2008 and March 2017.

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Preserved source evidence · Not medical advice