Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
Shanghai Jiao Tong University School of Medicine
120 participants
Dec 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria2
- Patients with active infection (bacteria, fungal or viral)
- Patients with abnormal liver, renal and cardiac function
Interventions
conditioning regimen with melphalan, busulfan and fludarabine
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06829472