VA Consolidation in Intermediate-Risk AML

Summary

This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Eligibility

Inclusion Criteria:

* Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria;
* Age ≥ 18 years;
* Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification;
* Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy;
* Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);
* ECOG performance status score 0 to 2
* Adequate organ function: creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \> 8 weeks
* Voluntarily signed informed consent form and able to comply with study requirements

Exclusion Criteria:

* Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months)
* Active central nervous system (CNS) leukemia or extramedullary infiltration
* Other serious diseases limiting participation (e.g., severe infection, renal failure)
* Known HIV infection or uncontrolled severe viral hepatitis
* Pregnant or breastfeeding women
* Inability to understand, comply with protocol, or sign informed consent
* Any other conditions deemed unsuitable by the investigator

Conditions4

Interventions2

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