drugset / Trial / NCT06829472

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

NCT06829472

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-01
Primary completion
2026-07-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 100 mg/m2
Subject Melphalan Small molecule 140 mg/m2