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.
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.
Acute promyelocytic leukemia with PML-RARA fusion gene.
Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.
Acute myeloid leukemia with BCR-ABL fusion gene.
Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).