Trial · NCT04160052
Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome
NCT04160052, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome. Trials, record NCT04160052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04160052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome
- NCT number
- NCT04160052
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Therapy-Related Myelodysplastic Syndrome
- Interventions
- Azacitidine, Venetoclax
- First posted
- 2019-11-12
- Last updated
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of the combination regimen of venetoclax and azacitidine (Phase I) | Up to 8 weeks | The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity. |
| Primary | Incidence of adverse events (Phase I) | Up to 5 years | Safety data will be summarized by category, severity, and frequency. |
| Secondary | Overall response rate (Phase 2) | Up to 5 years | Will be defined as the proportion of patients who had complete remission (CR), partial remission (PR), marrow complete remission, or hematologic improvement lasting at least 4 weeks. Will estimate the overall response rate for the combination treatment, along with the 95% confidence interval. |
| Secondary | Rate of CR | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of marrow/morphologic CR | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of hematologic improvement | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of red blood cell transfusion independence | Up to 5 years | |
| Secondary | Rate of platelet transfusion independence | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of cytogenetic response | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of bone marrow blast response | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36063832 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04160052
GET https://conductscience.org/api/trials/v1/NCT04160052/registered