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Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.
Official title: A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
788
Start Date
2026-04-29
Completion Date
2031-04-01
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
400 mg on days 1-7, every 6 weeks for 12 cycles
Azacitidine
50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles