A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia

This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial. A total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.

Inclusion Criteria: * Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%). * Age ≥14 years, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol. * Meet the following laboratory test requirements (assessed within 7 days prior to treatment): 1. Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group; 2. AST and ALT ≤2.5 × ULN for the same age group; 3. Serum creatinine \