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

Acute Myeloid Leukemia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04062266
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Tapan M. Kadia
• Phone: 713-563-3534
• Email: tkadia@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: September 13, 2019
• Completion date: October 31, 2030