Adding venetoclax to fludarabine–melphalan conditioning for people over 50 with AML or MDS getting a donor stem cell transplant

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 is a multicenter, randomized Phase 3 trial enrolling patients older than 50 with acute myeloid leukemia in remission or higher‑risk myelodysplastic syndromes who are planned for allogeneic hematopoietic stem cell transplantation. Participants are stratified by age and disease (AML vs MDS) and randomized to receive either standard fludarabine plus melphalan conditioning or the same regimen with venetoclax added. Venetoclax is given orally days −8 to −2 with antifungal drug–based dose adjustments, and melphalan dose is adjusted by patient age. The trial compares transplant outcomes including relapse, survival, and safety between the two arms across several Chinese transplant centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged \> 50 years;
2. Confirmed as acute myeloid leukemia (AML) in remission prior to transplantation, myelodysplastic syndrome (MDS; IPSS: Intermediate-2, high; or IPSS-R: Intermediate, high, very high; or IPSS-M: moderate-high, high, and very high), or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) by morphology, immunology, cytogenetics and molecular biology (MICM) typing;
3. Having an eligible donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (Allo-HCT) from a related or unrelated donor;
4. Karnofsky Performance Score ≥ 70;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3;
6. Expected survival time \> 12 weeks;
7. Voluntarily signing the informed consent form and being able to understand and comply with all study requirements.

Exclusion Criteria:

1. Complicated with severe cardiac insufficiency with a left ventricular ejection fraction (EF) \< 60%; or complicated with severe arrhythmia, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;
2. Complicated with severe pulmonary insufficiency (obstructive and/or restrictive ventilatory disorder), and assessed by the investigator as unable to tolerate the intensive conditioning regimen;
3. Complicated with severe liver function impairment, with liver function indicators (alanine aminotransferase \[ALT\], total bilirubin \[TBIL\]) exceeding 3 times the upper limit of normal (ULN); and assessed by the investigator as unable to tolerate the intensive conditioning regimen;
4. Complicated with severe renal insufficiency, with serum creatinine (Cr) exceeding 2 times the upper limit of normal (ULN); or with a 24-hour creatinine clearance rate (Ccr) \< 50 ml/min, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;
5. Suffering from severe active infection prior to transplantation, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;
6. Having a history of allergic reactions or severe adverse reactions to the drugs involved in the conditioning regimen, and assessed by the investigator as ineligible for enrollment;
7. Other reasons for ineligibility assessed by the investigator.

Where it's running

• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Nanfang Hospital Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Xiangya Hospital Central South University
  Changsha, Hunan, China Recruiting
• Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yi Luo, Professor
• Email: luoyijr@zju.edu.cn
• Phone: 0571 87233801

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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.