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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Jiao Tong University School of Medicine

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

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Clinical Research Center

Collaborator