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).
Parallel
Daunorubicin
Drugdaunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3,
Cytarabine
DrugCytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7,
Liposome Mitoxantrone
DrugLiposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1,
Venetoclax
DrugVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po),
Azacitidine
DrugAzacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7,
Venetoclax
DrugVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts \>5%, then venetoclax 400 mg is continued on days 21-28.
Daunorubicin
Drugdaunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2,
Cytarabine
DrugCytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5,
Venetoclax
DrugVenetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po),
Event-free survival (EFS)
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
30-day postinduction mortality
It is defined as death from any cause within 30 days after the start of induction.
60-day postinduction mortality
It is defined as death from any cause within 60 days after the start of induction.
Composite complete remission (CRc) rate
Proportion of patients with complete remission (CR), complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi).
Measurable Residual Disease (MRD) negative rate by flow cytometry
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative by flow cytometry.
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