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Recruiting Phase 3 NCT06829472

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

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Trial Parameters

Condition Toxicities
Sponsor Shanghai Jiao Tong University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2023-12-01
Completion 2026-07-01
Interventions
melphalan

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Brief 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 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

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