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Trial · NCT03862157

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT03862157, Phase 1, Phase 2, Active not recruiting, M.D. Anderson Cancer Center

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT03862157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03862157

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT number
NCT03862157
Status
Active not recruiting
Phases
Phase 1, Phase 2
Enrollment
40 participants, actual
Lead sponsor
M.D. Anderson Cancer Center
Conditions
Acute Myeloid Leukemia, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Eosinophilic Leukemia, Not Otherwise Specified, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myeloid Neoplasm, Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Unclassifiable, Overt Primary Myelofibrosis, Polycythemia Vera, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Prefibrotic/Early Primary Myelofibrosis
Interventions
Azacitidine, Pevonedistat, Venetoclax
First posted
2019-03-05
Last updated
2026-07-16

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of dose-limiting toxicities (DLTs) (Phase I)Up to 28 days from treatment start date
PrimaryComplete response (CR)/complete response with incomplete bone marrow recovery (CRi) rate (Phase II acute myeloid leukemia cohort)Up to 168 days (6 cycles)
PrimaryComplete response rate of the combination regimen (Phase II newly diagnosed myelodysplastic syndrome [MDS]/chronic myelomonocytic leukemia [CMML] cohort)Up to 168 days (6 cycles)
PrimaryCR + marrow CR (mCR) + partial remission (PR) + hematological improvement (HI) rate of the combination regimen (Phase II MDS/CMML post-hypomethylating agent failure cohort)Up to 168 days (6 cycles)
SecondaryLeukemia response rate (CR + CRi + partial response [PR] + morphologic leukemia-free state [MLFS])Up to 5 years
SecondaryMinimal residual disease negativity rateUp to cycle 24, day 28Measured by flow cytometry.
SecondaryDuration of responseTime from response to relapse, assessed up to 5 years
SecondaryRelapse-free survival (RFS)Time from response to relapse, death, or last follow-up, assessed up to 5 years
SecondaryEvent-free survival (EFS)Time from initiation of treatment to relapse, death or last follow-up, assessed up to 5 years
SecondaryOverall survival (OS)Time from initiation of treatment to death or last follow-up, assessed up to 5 years

Outcomes0

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.

PMIDListed as
37422688DERIVED

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA016672The University of Texas MD Anderson Cancer Center Support Grant (CCSG)KOONG, ALBERTUNIVERSITY OF TX MD ANDERSON CAN CTRNATIONAL CANCER INSTITUTE1985 to 2026

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT03862157

GET https://conductscience.org/api/trials/v1/NCT03862157/registered