VA Consolidation in Intermediate-Risk AML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Venetoclax and Azacitidine
- Cytarabine ± Anthracycline
Treatment groups
226 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov