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NCT00369317 · FLOW

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Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes · Source last updated 2022-01-28

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

groups
  1. description
    INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Combination Chemotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        205
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        185
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Combination Chemotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        205
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        185
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice