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: 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

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
nct id: NCT00313586
trial label: Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid 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: 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

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
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