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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed intermediate-risk acute myeloid leukemia (AML) who are in remission after venetoclax and azacitidine and plan to have a stem cell transplant from a donor.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia of intermediate risk (ELN 2022). Complete remission, or complete remission with incomplete blood count recovery, after 2 cycles or fewer of induction. A stem cell transplant from a donor is planned.
- Earlier treatment
- Must have had 2 cycles or fewer of venetoclax plus azacitidine (VA) as first treatment and reached remission.
Main reasons for not taking part
- Active heart disease (uncontrolled heart rhythm problems or high blood pressure, NYHA Class 3/4 heart failure, heart attack within 3 months)
- Leukemia in the central nervous system or outside the bone marrow
- Known HIV infection or uncontrolled severe viral hepatitis
- Pregnant or breastfeeding women
- Other serious illness, such as severe infection or kidney failure
Read by machine on 9 November 2026.
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.