Overview

Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Status:
Recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Treatments:
Busulfan
Fludarabine
Fludarabine phosphate
Melphalan
Vidarabine