Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) before they receive a stem cell transplant. The researchers want to find out if using a lower dose of a medication called melphalan (either 100 mg or 140 mg) combined with other drugs results in fewer side effects while still effectively preventing the cancer from coming back. This is important because it could help improve the quality of life for patients undergoing this treatment.

To be eligible for the trial, patients should be adults aged 65 to 74 who are in their first remission from AML or have a certain level of MDS. They must have a suitable donor for the transplant and must not have any active infections or serious problems with their liver, kidneys, or heart. Participants can expect to receive one of the two doses of melphalan as part of their treatment and will be closely monitored for their health and response to the transplant. This trial is currently looking for volunteers who meet these criteria.

Gender

ALL

Eligibility 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