Comparing two treatments for elderly patients with acute myeloid leukemia after initial remission

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 study investigates the effectiveness of two different consolidation therapies for elderly patients aged 60-75 with acute myeloid leukemia (AML) who have achieved complete remission after induction chemotherapy. One group will receive venetoclax, a BCL-2 inhibitor, while the other will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study aims to determine which treatment strategy offers better outcomes for patients at intermediate to high risk of relapse. It is a prospective, open-label, two-arm, non-randomized study conducted at a single center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with AML according to the 2022 WHO diagnostic criteria;
* Age 60-75 years;
* Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L);
* Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy;
* Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN;
* Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \> 8 weeks;
* Voluntarily signed the informed consent form and can understand and comply with the study's requirements.

Exclusion Criteria:

* Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening;
* Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
* Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication;
* Pregnant or breastfeeding women;
* Unable to understand, comply with the study protocol, or unable to sign the informed consent form.

Where it's running

• The First Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yanmin Zhao, PhD
• Email: yanminzhao@zju.edu.cn
• Phone: 15858199217

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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.