Venetoclax with azacitidine after remission in intermediate-risk acute myeloid leukemia
Tests venetoclax with azacitidine as follow-up treatment in adults with leukemia.
Plain-language title generated from the registry record
Registry title: VA Consolidation in Intermediate-Risk AML
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07672262
- Record updated
- 6 August 2026
- Original description
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).Read full original descriptionShow less
A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Intermediate-Risk Acute Myeloid Leukemia
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).
Inclusion: 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: Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months); Other serious diseases limiting participation (e.g., severe infection, renal failure); Known HIV infection or uncontrolled severe viral hepatitis; Any other conditions deemed unsuitable by the investigator; Active central nervous system (CNS) leukemia or extramedullary infiltration; Pregnant or breastfeeding women; Inability to understand, comply with protocol, or sign informed consent.