Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07539818
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    400 mg on days 1-7, every 6 weeks for 12 cycles
  • Azacitidine — DRUG
    50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2031

Study Design

Enrollment
788 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VA
    Azacitidine 50 mg/m²/day on days 1-5 + Venetoclax 400 mg on days 1-7, every 6 weeks for 12 cycles
  • Active Comparator: AZA
    Azacitidine 50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles

Primary Outcome Measure

Disease-Free Survival [ Time Frame: up to 2 years ]

Central Contacts

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