NCT06903702

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

A Randomized, Multicenter, Phase II Study of Maintenance Azacitidine and Venetoclax Versus an Allogeneic Stem Cell Transplant in Older Patients (65 Years and Older) With Acute Myeloid Leukemia Who Achieve an MRD Negative Complete Remission After Induction With Azacitidine and Venetoclax

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-04-01
• Last updated: 2025-08-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study