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

NCT03862157 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-11

No results posted yet for this study

Summary

This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.

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

DRUG

Azacitidine

Given IV or SC

DRUG

Pevonedistat

Given IV

DRUG

Venetoclax

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nicholas Short · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862157 on ClinicalTrials.gov