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← Childhood Acute Myeloid Leukemia

NCT00369317 · STUDY IN CONTEXT

Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Event-free Survival (EFS) at 3 Years

Ineligible patients are excluded from analyses of event free survival and overall survival.

→

primary · POSTED

Overall Survival (OS) at 3 Years

Ineligible patients are excluded from analyses of overall survival and event free survival.

→

secondary · POSTED

Proportion of participants with a remission after four courses of Induction therapy.

Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate.

→

secondary · POSTED

Proportion of participants with at least one grade 3 or higher adverse event during therapy.

Ineligible patients (n=1) are excluded.

→

secondary · POSTED

Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.

Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse.

→

secondary · POSTED

Proportion of participants having GATA1 mutation among patients with phenotype data available.

Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric
nct id
NCT00369317
trial label
Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0000
    source section id
    NCT00369317-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival (EFS) at 3 Years
    endpoint definition
    Event-free Survival (EFS) at 3 Years
    time origin
    Time from study entry to induction failure, relapse, or death assessed at 3 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients are excluded from analyses of event free survival and overall survival.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0001
    source section id
    NCT00369317-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) at 3 Years
    endpoint definition
    Overall Survival (OS) at 3 Years
    time origin
    Time from study entry to death, assessed at 3 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients are excluded from analyses of overall survival and event free survival.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0002
    source section id
    NCT00369317-om-0002
    source outcome index
    2
    endpoint
    Induction Remission Rate
    endpoint definition
    Proportion of participants with a remission after four courses of Induction therapy.
    time origin
    End of induction therapy (day 112)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0003
    source section id
    NCT00369317-om-0003
    source outcome index
    3
    endpoint
    Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    endpoint definition
    Proportion of participants with at least one grade 3 or higher adverse event during therapy.
    time origin
    From the beginning of induction therapy to the end of intensification therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients (n=1) are excluded.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0004
    source section id
    NCT00369317-om-0004
    source outcome index
    4
    endpoint
    Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry
    endpoint definition
    Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.
    time origin
    At the start of therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0005
    source section id
    NCT00369317-om-0005
    source outcome index
    5
    endpoint
    Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis
    endpoint definition
    Proportion of participants having GATA1 mutation among patients with phenotype data available.
    time origin
    At baseline and at the end of therapy (intensification) or disease relapse
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    204
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    204
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    195
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    204
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    164
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Combination Chemotherapy)
    regimen
    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
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369317-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00369317
    harm key
    EG000
    source section id
    NCT00369317-ae
    event group key
    EG000
    event group label
    Treatment (Combination Chemotherapy)
    serious affected
    3
    serious at risk
    204
    other affected
    185
    other at risk
    204
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice