Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

For adult patients with newly diagnosed acute myeloid leukemia (AML) who are eligible for intensive chemotherapy, the standard intensive induction regimen remains anthracycline combined with cytarabine. However, the efficacy of traditional intensive chemotherapy is limited in high-risk AML and is associated with significant myelosuppression and infection risk, underscoring the need for novel therapeutic strategies. This study was therefore designed as a prospective, multicenter, randomized controlled trial. The study plans to enroll 204 adults with newly diagnosed AML. Participants will be randomized in a 2:1 ratio to receive induction therapy with either: 1) venetoclax, azacitidine, and mitoxantrone hydrochloride liposome (MVA), or 2) idarubicin and cytarabine (IA). The primary endpoint is the composite complete remission (CRc) rate following one cycle of induction therapy.