MedTrace Logo

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

NCT04266795 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-10-21

Study results available
· View outcomes & findings →

Summary

The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.

Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin).

Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Pevonedistat

Pevonedistat IV infusion.

DRUG

Venetoclax

Venetoclax tablets.

DRUG

Azacitidine

Azacitidine IV or SC injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2022-09-06
Completion
2025-10-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04266795 on ClinicalTrials.gov