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Recruiting Phase 3

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

About this study

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.

Condition
Toxicities, Survivorship
Tested
melphalan
Sponsor
Shanghai Jiao Tong University School of Medicine

Who can join

Age
18 to 55 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Maximum age: 55 years
  • Study condition: Toxicities, Survivorship
  • 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 2

  • Patients with active infection (bacteria, fungal or viral)
  • Patients with abnormal liver, renal and cardiac function

Where

2 sites, 2 recruiting

Rui Jin Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.