Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.
• Gender: female or male.
• Age:18-64 years old.
• Patients with newly diagnosed AML according to the WHO 2022 classification.
• AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification.
• Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose \<1.0g are permitted).
• ECOG: 0-2.
• Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) .
• Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
• Be able to understand and be willing to participate in the study. Be able to provide written informed consent.