Trial · NCT00313586
Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
NCT00313586, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia. Trials, record NCT00313586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313586
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
- NCT number
- NCT00313586
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Alkylating Agent-Related Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Untreated Adult Acute Myeloid Leukemia
- Interventions
- Azacitidine, Entinostat, Laboratory Biomarker Analysis
- First posted
- 2006-04-12
- Last updated
- 2017-02-02
- Results first posted
- 2014-11-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Clinical Response | Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry. | 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.) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Clinical Response | Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry. | All treated patients are included in the analysis. | Proportion of patients | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Clinical Response | Arm A (Azacitidine; Non-treatment-induced Cohort) | 0.32 | 95% Confidence Interval 0.22 to 0.44 | Proportion of patients | |
| Proportion of Patients With Clinical Response | Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) | 0.27 | 95% Confidence Interval 0.17 to 0.39 | Proportion of patients | |
| Proportion of Patients With Clinical Response | Arm A (Azacitidine; Treatment-induced Cohort) | 0.46 | 95% Confidence Interval 0.26 to 0.67 | Proportion of patients | |
| Proportion of Patients With Clinical Response | Arm B (Azacitidine + Entinostat; Treatment-induced Cohort) | 0.17 | 95% Confidence Interval 0.05 to 0.39 | Proportion of patients |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Azacitidine; Non-treatment-induced Cohort) | 75 | |
| Overall Study | STARTED | Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) | 75 | |
| Overall Study | STARTED | Arm A (Azacitidine; Treatment-induced Cohort) | 24 | |
| Overall Study | STARTED | Arm B (Azacitidine + Entinostat; Treatment-induced Cohort) | 23 | |
| Overall Study | Treated | Arm A (Azacitidine; Non-treatment-induced Cohort) | 74 | |
| Overall Study | Treated | Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) | 75 | |
| Overall Study | Treated | Arm A (Azacitidine; Treatment-induced Cohort) | 24 | |
| Overall Study | Treated | Arm B (Azacitidine + Entinostat; Treatment-induced Cohort) | 23 | |
| Overall Study | COMPLETED | Arm A (Azacitidine; Non-treatment-induced Cohort) | 5 | |
| Overall Study | COMPLETED | Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) | 5 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm A (Azacitidine) | 5 | 99 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm B (Azacitidine + Entinostat) | 4 | 98 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm A (Azacitidine) | 80 | 99 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm B (Azacitidine + Entinostat) | 74 | 98 | |
| other | Leukocytes | Investigations | Arm A (Azacitidine) | 67 | 99 | |
| other | Leukocytes | Investigations | Arm B (Azacitidine + Entinostat) | 57 | 98 | |
| other | Lymphopenia | Investigations | Arm A (Azacitidine) | 11 | 99 | |
| other | Lymphopenia | Investigations | Arm B (Azacitidine + Entinostat) | 8 | 98 | |
| other | Neutrophils | Investigations | Arm A (Azacitidine) | 56 | 99 | |
| other | Neutrophils | Investigations | Arm B (Azacitidine + Entinostat) | 49 | 98 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Azacitidine) | ||
| Total, all-cause mortality | Arm B (Azacitidine + Entinostat) | ||
| Total, other adverse events | Arm A (Azacitidine) | 96 | 99 |
| Total, other adverse events | Arm B (Azacitidine + Entinostat) | 97 | 98 |
| Total, serious adverse events | Arm A (Azacitidine) | 92 | 99 |
| Total, serious adverse events | Arm B (Azacitidine + Entinostat) | 93 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26577691 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Azacitidine) vs Arm B (Azacitidine + Entinostat): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00313586
GET https://conductscience.org/api/trials/v1/NCT00313586/events?page=2