About this trial
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
Qualifiers
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
Disqualifiers
Patients with active infection (bacteria, fungal or viral)
Patients with abnormal liver, renal and cardiac function
Trial design
Treatments tested in this trial
- melphalan
Treatment groups
Sponsors and collaborators
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Clinical Research Center
Collaborator