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.
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
Patients with active infection (bacteria, fungal or viral)
Patients with abnormal liver, renal and cardiac function
Parallel
melphalan
Drugconditioning regimen with melphalan, busulfan and fludarabine
Toxicities
Toxicities with grade III or over
Relapse
Documentation of bone marrow blasts \>5% or extra medullary disease
Non-relapse mortality
Death without documentation of AML and MDS disease
Non-relapse mortality
Death without documentation of AML and MDS disease
disease-free survival
event defined as documentation of AML and MDS relapse or death of any causes
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Clinical Research Center
Collaborator
