Trial · NCT00948064
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
NCT00948064, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS). Trials, record NCT00948064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00948064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
- NCT number
- NCT00948064
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Vorinostat, Azacitidine
- First posted
- 2009-07-29
- Last updated
- 2020-02-24
- Results first posted
- 2015-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival at Day 60 | Phase I, Baseline to 60 days following first treatment. | Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause. |
| Primary | Response Rate | 12-18 Months | Number of participants with Complete Response (CR) in AML requiring disappearance of all signs and symptoms related to disease, normalization of peripheral counts (absolute neutrophil count 10\^9/L or more, platelet count 100 x 10\^9/L or more), and a marrow with 5% or less marrow blasts; a hematologic improvement (HI) defined as a CR except for a platelet count increase by 50% to above 30 x 10\^9/L. For MDS, the International Working Group criteria used to assess response. |
| Primary | Survival at Day 60 | Phase II, Baseline to 60 days following first treatment. | Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival at Day 60 | Phase I, Baseline to 60 days following first treatment. | Of the 31 enrolled participants, 30 were evaluable and 1 participant never received treatment. | participants | NUMBER |
| PRIMARY | Response Rate | 12-18 Months | Out of 79 participants enrolled in Phase II, 2 participants were not evaluable - 1 participant was removed from study per treating physician discretion and the other was removed per participant's request. | participants | NUMBER |
| PRIMARY | Survival at Day 60 | Phase II, Baseline to 60 days following first treatment. | Of the 79 participants enrolled, 78 were evaluable and 1 participant withdrew from study. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival at Day 60 | Vorinostat With Azacitidine, Phase I | 24 | participants | ||
| Response Rate | Vorinostat With Azacitidine, Phase I | Complete Response | 9 | participants | |
| Response Rate | Vorinostat With Azacitidine, Phase II | Complete Response | 11 | participants | |
| Response Rate | Azacitidine, Phase II | Complete Response | 8 | participants | |
| Response Rate | Vorinostat With Azacitidine, Phase I | Hematologic Improvement | 0 | participants | |
| Response Rate | Vorinostat With Azacitidine, Phase II | Hematologic Improvement | 1 | participants | |
| Response Rate | Azacitidine, Phase II | Hematologic Improvement | 1 | participants | |
| Response Rate | Vorinostat With Azacitidine, Phase I | No Response | 21 | participants | |
| Response Rate | Vorinostat With Azacitidine, Phase II | No Response | 39 | participants | |
| Response Rate | Azacitidine, Phase II | No Response | 17 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Vorinostat With Azacitidine, Phase I | 31 | |
| Phase I | STARTED | Vorinostat With Azacitidine, Phase II | 0 | |
| Phase I | STARTED | Azacitidine, Phase II | 0 | |
| Phase I | COMPLETED | Vorinostat With Azacitidine, Phase I | 30 | |
| Phase I | COMPLETED | Vorinostat With Azacitidine, Phase II | 0 | |
| Phase I | COMPLETED | Azacitidine, Phase II | 0 | |
| Phase I | NOT COMPLETED | Vorinostat With Azacitidine, Phase I | 1 | |
| Phase I | NOT COMPLETED | Vorinostat With Azacitidine, Phase II | 0 | |
| Phase I | NOT COMPLETED | Azacitidine, Phase II | 0 | |
| Phase II | STARTED | Vorinostat With Azacitidine, Phase I | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | Alanine Transaminase (ALT) | Metabolism and nutrition disorders | Vorinostat With Azacitidine, Phase I | 1 | 30 | 3 |
| other | Alanine Transaminase (ALT) | Metabolism and nutrition disorders | Vorinostat With Azacitidine, Phase II | 0 | 52 | 0 |
| other | Alanine Transaminase (ALT) | Metabolism and nutrition disorders | Azacitidine, Phase II | 0 | 27 | 0 |
| other | Bilirubin | Metabolism and nutrition disorders | Vorinostat With Azacitidine, Phase I | 2 | 30 | 5 |
| other | Bilirubin | Metabolism and nutrition disorders | Vorinostat With Azacitidine, Phase II | 0 | 52 | 0 |
| other | Bilirubin | Metabolism and nutrition disorders | Azacitidine, Phase II | 0 | 27 | 0 |
| other | Constipation | Gastrointestinal disorders | Vorinostat With Azacitidine, Phase I | 7 | 30 | 10 |
| other | Constipation | Gastrointestinal disorders | Vorinostat With Azacitidine, Phase II | 17 | 52 | 44 |
| other | Constipation | Gastrointestinal disorders | Azacitidine, Phase II | 6 | 27 | 13 |
| other | Creatinine | Metabolism and nutrition disorders | Vorinostat With Azacitidine, Phase I | 2 | 30 | 5 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorinostat With Azacitidine, Phase I | ||
| Total, all-cause mortality | Vorinostat With Azacitidine, Phase II | ||
| Total, all-cause mortality | Azacitidine, Phase II | ||
| Total, other adverse events | Vorinostat With Azacitidine, Phase I | 21 | 30 |
| Total, other adverse events | Vorinostat With Azacitidine, Phase II | 45 | 52 |
| Total, other adverse events | Azacitidine, Phase II | 26 | 27 |
| Total, serious adverse events | Vorinostat With Azacitidine, Phase I | 15 | 30 |
| Total, serious adverse events | Vorinostat With Azacitidine, Phase II | 36 | 52 |
| Total, serious adverse events | Azacitidine, Phase II | 18 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27795561 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vorinostat With Azacitidine, Phase II vs Azacitidine, Phase II: Survival at Day 60 |
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/NCT00948064
GET https://conductscience.org/api/trials/v1/NCT00948064/events?page=2