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← Childhood Acute Promyelocytic Leukemia

NCT00866918 · STUDY IN CONTEXT

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

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

EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.

Ineligible and inevaluable patients are excluded from analyses of EFS.

→

secondary · POSTED

Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.

Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.

→

secondary · POSTED

Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.

Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.

→

secondary · POSTED

OS - time from study entry to death.

Ineligible and inevaluable patients are excluded from analyses of OS.

→

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-promyelocytic-leukemia-pediatric
nct id
NCT00866918
trial label
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
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
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0000
    source section id
    NCT00866918-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival (EFS)
    endpoint definition
    EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.
    time origin
    At 3 years from study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible and inevaluable patients are excluded from analyses of EFS.
    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-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0001
    source section id
    NCT00866918-om-0001
    source outcome index
    1
    endpoint
    Hematologic Remission Rate
    endpoint definition
    Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.
    time origin
    End of consolidation, course 1: up to 5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.
    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-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0002
    source section id
    NCT00866918-om-0002
    source outcome index
    2
    endpoint
    Hematologic, Molecular, and Cytogenetic Remission Rate
    endpoint definition
    Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.
    time origin
    End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.
    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-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0003
    source section id
    NCT00866918-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS - time from study entry to death.
    time origin
    At 3 years from study entry
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible and inevaluable patients are excluded from analyses of OS.
    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-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Standard Risk
    regimen
    WBC\<10,000/MicroLiter
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0000
    arm key
    OG001
    arm label
    High Risk
    regimen
    WBC\>=10,000/MicroLiter
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Standard Risk
    regimen
    WBC\<10,000/MicroLiter
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0001
    arm key
    OG001
    arm label
    High Risk
    regimen
    WBC\>=10,000/MicroLiter
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Standard Risk
    regimen
    WBC\<10,000/MicroLiter
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0002
    arm key
    OG001
    arm label
    High Risk
    regimen
    WBC\>=10,000/MicroLiter
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Standard Risk
    regimen
    WBC\<10,000/MicroLiter
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    outcome key
    om-0003
    arm key
    OG001
    arm label
    High Risk
    regimen
    WBC\>=10,000/MicroLiter
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00866918-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    harm key
    EG000
    source section id
    NCT00866918-ae
    event group key
    EG000
    event group label
    Standard Risk
    serious affected
    17
    serious at risk
    66
    other affected
    61
    other at risk
    66
    frequency threshold
    0
    collection period
    Source null
    event definition
    Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
    undenominated note
    Source null
    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-promyelocytic-leukemia-pediatric
    nct id
    NCT00866918
    harm key
    EG001
    source section id
    NCT00866918-ae
    event group key
    EG001
    event group label
    High Risk
    serious affected
    14
    serious at risk
    35
    other affected
    33
    other at risk
    35
    frequency threshold
    0
    collection period
    Source null
    event definition
    Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
    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