Comparing two doses of melphalan for stem cell transplantation in leukemia patients
Official title: Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
Run by Shanghai Jiao Tong University School of Medicine · NCT06829472 · Data updated 2026-11-12
This study is testing whether a lower or higher dose of melphalan helps adults with leukemia or myelodysplastic syndrome have better outcomes after stem cell transplantation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | fludarabine |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | July 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06829472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 55 with AML in first remission or MDS with specific bone marrow blast percentages.
✕Probably not a fit
Patients with active infections or significant organ dysfunction 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 investigates the effects of two different doses of melphalan (100 mg/m2 and 140 mg/m2) as part of a conditioning regimen for allogeneic stem cell transplantation in adults with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The research aims to determine which dose results in better transplantation outcomes and lower toxicities. Participants will be randomly assigned to receive one of the two doses, and their health outcomes will be monitored post-transplantation. The study builds on previous findings that indicated similar relapse rates for both doses but potentially lower toxicities with the lower dose.
Why it matters
Potential benefit: If successful, this study could lead to improved transplantation outcomes and reduced side effects for patients undergoing treatment for AML and MDS.
How similar studies have gone: Previous studies have shown promising results with similar conditioning regimens, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with AML in first remission * Patients with MDS with bone marrow blast \>5% but remain less than 20% before transplantation * Donor available: HLA matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor * Inform consent provided Exclusion Criteria: * Patients with active infection (bacteria, fungal or viral) * Patients with abnormal liver, renal and cardiac function
Where it's running
-
Rui Jin Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Zhaxin Hospital, Go Broad Health Care
Shanghai, Shanghai Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Chun Wang
- Email: Wangchunsh@mefmail.com.cn
- Phone: 86-13386259777
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.