Comparing two doses of melphalan for stem cell transplantation in leukemia patients
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.
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 |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | fludarabine |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06829472 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with AML in first remission or MDS with specific bone marrow blast percentages.
Not a fit: Patients with active infections or significant organ dysfunction may not benefit from this study.
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 performed: Previous studies have shown promising results with similar conditioning regimens, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.