RecruitingPhase 3NCT06829472

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

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.

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

120 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Toxicities Survivorship

Summary

Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different doses of the drug melphalan within a conditioning regimen (high-dose chemotherapy given before a bone marrow transplant) to find the safest and most effective approach for people with blood cancers undergoing a stem cell transplant. **You may be eligible if...** - You have acute myeloid leukemia (AML) in first remission — meaning the cancer has responded to initial treatment - OR you have myelodysplastic syndrome (MDS) with a moderate level of abnormal bone marrow cells (between 5–20% blasts) - A compatible stem cell donor is available (matched sibling, matched unrelated, or half-matched donor) - You have given informed consent **You may NOT be eligible if...** - You have an active bacterial, fungal, or viral infection - You have significantly abnormal liver, kidney, or heart function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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