NCT06773208

A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)

A Phase 2 Study of Azacitidine and Venetoclax to Treat Acute Myeloid Leukemia Patients With Measurable Residual Disease Before an Allogeneic Stem Cell Transplant

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if azacitidine and venetoclax are an effective treatment approach to get rid of or lower measurable residual disease (MRD) in people with acute myeloid leukemia (AML) who have received standard chemotherapy and are planning to have an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic HSCT, sometimes called a bone marrow transplant, involves receiving healthy blood-forming cells (stem cells) from a donor in order to replace the patient's immune system and lower the chances of the disease returning (relapse).

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Azacitidine (AZC)	75 mg/m2 daily, on days 1-7, given IV or SC
DRUG	Venetoclax	Venetoclax 400 mg orally daily on days 1-28

Timeline

• Start date: 2025-01-07
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-01-14
• Last updated: 2026-02-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study