Venetoclax combined with homoharringtonine, cytarabine and aclacinomycin as induction therapy in newly diagnosed Chinese acute myeloid leukaemia patients: A multicentre phase II study.
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To evaluate the efficacy and safety of the HAAV regimen (venetoclax, aclarubicin, cytarabine, homoharringtonine) as induction therapy for newly diagnosed adult acute myeloid leukaemia (AML). This multicentre, single-arm, prospective clinical trial included 84 AML patients (aged 18-60) from eight Chinese hospitals. The HAAV regimen was administered, with venetoclax dosed at 100 mg on day 1, 200 mg on day 2 and 400 mg on days 3-8, combined with homoharringtonine, cytarabine and aclarubicin on days 3-7. The overall response rate after one cycle was 95.2% (95% confidence interval [CI] 88.3-98.7), with 92.9% achieving complete remission + incomplete count recovery (95% CI 83.6-96.6). Among responders, 89.9% (95% CI 80.2-95.8) had minimal residual disease negativity. With a median follow-up of 15.5 months, the -1-year overall survival was 77.9% (95% CI 18.3-26.1), relapse-free survival was 83.9% (95% CI 19.2-22.3) and event-free survival was 71.3% (95% CI 16.9-20.5). The HAAV regimen is highly efficacious and safe for newly diagnosed AML patients.