Venetoclax and Azacitidine Consolidation After Remission in Intermediate-Risk AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, multi-center study compares VA consolidation (venetoclax 400 mg days 1-28 with azacitidine days 1-7, for 1-2 cycles) to conventional cytarabine-based consolidation in adults with intermediate-risk AML who achieved CR/CRi after VA induction and plan allo-HSCT. The primary endpoint is 2-year leukemia-free survival, with secondary endpoints including MRD-negative rate before transplant, overall survival, relapse incidence, non-relapse mortality, and safety per CTCAE v5.0. Eligible patients must be ELN 2022 intermediate-risk, have suitable donors, adequate organ function, and an ECOG 0-2. The aim is to determine non-inferiority of VA consolidation with potentially better safety compared with standard intensive chemotherapy. This study will contribute evidence on consolidation strategies in the venetoclax era for this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qi Qu
• Email: quqimedsz@163.com
• Phone: +86-512-676976801

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax plus azacitidine consolidation vs standard chemotherapy before stem cell transplant in high-risk AML

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.