Clinical trial Recruiting at 9 sites Phase 3 Interventional Ages 16 to 55

Comparing conditioning regimens for patients with acute myeloid leukemia or myelodysplastic syndromes

Official title: Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)

Run by Shanghai Jiao Tong University School of Medicine · NCT05991908 · Data updated 2026-11-12

This study is testing two different treatment plans for adults with acute myeloid leukemia or myelodysplastic syndromes to see which one helps prevent the disease from coming back after a stem cell transplant.

Quick facts

PhasePhase 3
Study typeInterventional
Ages16 Years to 55 Years
SexAll
Enrollment222 (estimated)
SponsorShanghai Jiao Tong University School of Medicine
Academic / other
Drugs / interventionsFludarabine
Locations9 sites (Fuzhou, Fujian and 8 other locations)
StatusRecruiting
StartedOctober 19, 2023
Main results expectedOctober 30, 2025
Study endsJune 30, 2026
Registry record updatedFebruary 18, 2025
Trial IDNCT05991908 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with AML in first complete remission or MDS with specific bone marrow blast percentages, who have suitable HLA-matched donors.

Probably not a fit

Patients with active infections, certain organ dysfunctions, or those with specific viral infections like HIV may not benefit from this study.

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

What this trial studies

This study aims to compare the outcomes of two different conditioning regimens for adult patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem cell transplantation (allo-HSCT). One regimen consists of fludarabine and busulfan, while the other includes fludarabine, busulfan, and melphalan. The goal is to determine which regimen results in a lower incidence of disease relapse post-transplantation. The study is conducted across multiple centers and involves random assignment of participants to each treatment group.

Why it matters

Potential benefit: If successful, this study could lead to improved transplantation outcomes and lower relapse rates for patients with AML and MDS.

How similar studies have gone: Previous studies have shown promising results with dual alkylating agent regimens, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
* myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation
* patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
* inform consent provided

Exclusion Criteria:

* AML patients with active CNS or extramedullary diseases
* patients with active viral, bacterial or fungal infection
* patients with hepatitis B virus \>1X103 copy/ml
* patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
* patients with uncontrolled mental disorders
* patients with HIV

Where it's running

  • Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
    Recruiting
  • Zhongshan Hospital, Xianmen University
    Xiamen, Fujian, China
    Recruiting
  • 923th Hospital PLA
    Nanning, Guangxi, China
    Recruiting
  • First Affiliated Hospital of Nanjin Medical Unviersity
    Nanjin, Jiangsu, China
    Recruiting
  • First Affiliatied Hospital of Soochow University
    Suzhou, Jiangsu, China
    Recruiting
  • Ruijin Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
Show 3 more locations
  • Shanghai No10 Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • 920th Hospital PLA
    Kunming, China
    Recruiting
  • Shanghai No 6 Hospital
    Shanghai, China
    Recruiting

Study contacts

  • Principal investigator: Chun Wang — Go Broad Health Center, Zhaxin Hospital
  • Study coordinator: chun Wang
  • Email: wangchunsh@126.com
  • Phone: 13386259777

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.