VA Consolidation in Intermediate-Risk AML

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07672262
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax and Azacitidine — DRUG
    Venetoclax: 400 mg, orally, once daily on Days 1-28. (Dose adjustment required per prescribing information/guidelines when combined with CYP3A4 inhibitors). Azacitidine: 75 mg/m²/day, subcutaneously or intravenously, on Days 1-7. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.
  • Cytarabine ± Anthracycline — DRUG
    Cytarabine (AraC): ≥6g/m² per cycle (e.g., 1-2g/m², every 12 hours on days 1-3), administered intravenously. May be combined with anthracycline/anthraquinone agents per standard practice. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.

Study Details

This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Key Dates

First listed
Jun 26, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

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

Arms

  • Experimental: Venetoclax + Azacitidine Consolidation
    Venetoclax: 400 mg, orally, once daily on Days 1-28. (Dose adjustment required per prescribing information/guidelines when combined with CYP3A4 inhibitors). Azacitidine: 75 mg/m²/day, subcutaneously or intravenously, on Days 1-7. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.
  • Active Comparator: Conventional Consolidation Chemotherapy
    Cytarabine (AraC): ≥6g/m² per cycle (e.g., 1-2g/m², every 12 hours on days 1-3), administered intravenously. May be combined with anthracycline/anthraquinone agents per standard practice. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.

Primary Outcome Measure

Leukemia-Free Survival (LFS) [ Time Frame: From the date of randomization to the date of first documented hematologic relapse, extramedullary relapse, or death from any cause, assessed up to 2 years. ]

Central Contacts

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