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← Childhood Acute Myeloid Leukemia

NCT01083706 · STUDY IN CONTEXT

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Count of surviving participants at 6 months.

Source null

→

secondary · POSTED

Count of participants achieving a complete or partial remission at 6 months.

Source null

→

secondary · POSTED

Incidence of Grades II-IV Graft-versus-host Disease (GVHD)

Source null

→

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
NCT01083706
trial label
Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT01083706
    outcome key
    om-0000
    source section id
    NCT01083706-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Count of surviving participants at 6 months.
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-myeloid-leukemia-pediatric
    nct id
    NCT01083706
    outcome key
    om-0001
    source section id
    NCT01083706-om-0001
    source outcome index
    1
    endpoint
    Rate of Response by IWG Criteria
    endpoint definition
    Count of participants achieving a complete or partial remission at 6 months.
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT01083706
    outcome key
    om-0002
    source section id
    NCT01083706-om-0002
    source outcome index
    2
    endpoint
    Incidence of Grades II-IV Graft-versus-host Disease (GVHD)
    endpoint definition
    Incidence of Grades II-IV Graft-versus-host Disease (GVHD)
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT01083706
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Chemotherapy)
    regimen
    Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01083706-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT01083706
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Chemotherapy)
    regimen
    Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01083706-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT01083706
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Chemotherapy)
    regimen
    Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01083706-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT01083706
    harm key
    EG000
    source section id
    NCT01083706-ae
    event group key
    EG000
    event group label
    Treatment (Chemotherapy)
    serious affected
    3
    serious at risk
    39
    other affected
    8
    other at risk
    39
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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