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A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia

NCT06903702 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-05

No results posted yet for this study

Summary

The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).

Conditions

Interventions

DRUG

Azacitidine (AZA)

given daily for 7 days starting on Day 1 of each Cycle

DRUG

Venetoclax

orally daily for 28 days

PROCEDURE

Allogeneic hematopoietic stem cell transplantation

After the conditioning treatment, the HSCT procedure is part of standard care on Day 0.

Sponsors & Collaborators

Principal Investigators

  • Roni Tamari, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT06903702 on ClinicalTrials.gov