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

In adults with newly diagnosed high-risk AML who have achieved CR or CRi after venetoclax plus azacitidine induction, participants are randomized to receive either a venetoclax-based consolidation regimen or the standard intermediate-dose cytarabine consolidation, followed by allogeneic stem cell transplantation. The trial aims to compare leukemia-free survival as the primary endpoint and assess overall survival, relapse rates, non-relapse mortality, MRD status before transplant, and safety. This is a Phase 2 interventional study designed to generate evidence for post-remission therapy after venetoclax-azacitidine induction. All participants proceed to allo-HSCT after 1-2 consolidation cycles. The study addresses whether the venetoclax-containing approach offers superior efficacy with an acceptable safety profile compared with conventional chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;
* Age ≥ 18 years;
* Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);
* Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;
* Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
* Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival \> 8 weeks;
* Voluntarily signed the informed consent form and can understand and comply with study requirements.

Exclusion Criteria:

* Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;
* Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;
* Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
* Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;
* Pregnant or breastfeeding women;
* Inability to understand, comply with the study protocol, or sign the informed consent form;
* Any other conditions deemed by the investigator as unsuitable for participation in this study.

Where it's running

• the First Affiliated Hosptital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qi Qu
• Email: quqimedsz@163.com
• Phone: +86 051267976801

Similar studies

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

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• Personalized AML: Find biomarkers to predict response to venetoclax

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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.