NCT04062266

AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

Phase II Study of 5-Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remission

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine and venetoclax, 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.

Detailed description

PRIMARY OBJECTIVES: I. To assess relapse-free survival (RFS) of patients (pts) with acute myeloid leukemia (AML) treated with 5-azacytidine (azacitidine; AZA) combined with venetoclax (VEN) as maintenance therapy after achieving remission. SECONDARY OBJECTIVES: I. To assess modified RFS of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. II. To assess overall survival (OS) of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. III. To assess event-free survival (EFS) of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. IV. To assess the duration of remission (CRd) of pts with AML treated 5-azacytidine combined with venetoclax as maintenance therapy. V. To assess toxicity and safety of 5-azacytidine combined with venetoclax as maintenance therapy in pts with AML. VI. To assess the effects of 5-azacytidine combined with venetoclax on dynamics of minimal residual disease (MRD) and their relationship to outcomes. OUTLINE: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over 1 hour daily on days 1-5, and venetoclax orally (PO) daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6-12 months thereafter.

Conditions

• Acute Myeloid Leukemia in Remission
• FLT3 Gene Mutation
• Hematologic and Lymphocytic Disorder
• Acute Myeloid Leukemia
• Minimal Residual Disease Persistence
• Therapy-Related Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given SC or IV
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2019-09-13
• Primary completion: 2030-10-31
• Completion: 2030-10-31
• First posted: 2019-08-20
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study