Venetoclax combined with homoharringtonine, cytarabine and aclacinomycin as induction therapy in newly diagnosed Chinese acute myeloid leukaemia patients: A multicentre phase II study.

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.