The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation.
The main questions it aims to answer are:
Does consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.
Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;
Age ≥ 18 years;
Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);
Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;
Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;
Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;
Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;
Parallel
Ara-C Group
DrugAra-C 1-2 g/m², every 12 hours, intravenous infusion, days 1-3; may be combined with anthracyclines/anthraquinones, followed by allo-HSCT after consolidation within 2 cycles.
VEN/AZA condsolidation
DrugVenetoclax 400 mg, orally, days 1-28 (the dose of Venetoclax should be adjusted according to the drug dosage instructions/guidelines when combined with CYP3A4 inhibitors); AZA: Azacitidine 75 mg/m² per day, subcutaneous injection, days 1-7. Patients will proceed to allo-HSCT after consolidation within 2 cycles.
Leukemia free survival
Time from date of achieving complete remission until date of first documented hematologic relapse, extramedullary relapse, or death from any cause, whichever occurs first.
Pretransplantation MRD negative rate
Proportion of patients who achieve minimal residual disease (MRD) negativity prior to hematopoietic stem cell transplantation, as assessed by multicolor flow cytometry, measured from bone marrow samples.
Overall survival
From the first day of randomization to the date of death from any cause
Cumulative relapse rate
From the date of achieving remission to the date of hematologic relapse.
Non-relapse mortality
The proportion of patients who died from causes unrelated to disease relapse/progression after achieving remission or receiving an intervention
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