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← recurrent Acute Myeloid Leukemia

NCT00313586 · STUDY IN CONTEXT

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria: 1. World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett) 2. Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.) 3. Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)

All treated patients are included in the analysis.

→

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-recurrent-c347d2fe
nct id
NCT00313586
trial label
Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
1
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    outcome key
    om-0000
    source section id
    NCT00313586-om-0000
    source outcome index
    0
    endpoint
    Proportion of Patients With Clinical Response
    endpoint definition
    Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria: 1. World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett) 2. Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.) 3. Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)
    time origin
    Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated patients are included in the analysis.
    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-recurrent-c347d2fe
    nct id
    NCT00313586
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (Azacitidine; Non-treatment-induced Cohort)
    regimen
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00313586-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
    regimen
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    analyzed count
    75
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00313586-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm A (Azacitidine; Treatment-induced Cohort)
    regimen
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00313586-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
    regimen
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00313586-om-0000#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    harm key
    EG000
    source section id
    NCT00313586-ae
    event group key
    EG000
    event group label
    Arm A (Azacitidine)
    serious affected
    92
    serious at risk
    99
    other affected
    96
    other at risk
    99
    frequency threshold
    5
    collection period
    Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-recurrent-c347d2fe
    nct id
    NCT00313586
    harm key
    EG001
    source section id
    NCT00313586-ae
    event group key
    EG001
    event group label
    Arm B (Azacitidine + Entinostat)
    serious affected
    93
    serious at risk
    98
    other affected
    97
    other at risk
    98
    frequency threshold
    5
    collection period
    Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
    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