drugset / Trial / NCT05991908

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

NCT05991908

Phase 3 Recruiting 222 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-10-19
Primary completion
2025-10-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Busulfan Small molecule 6.4 mg/kg
Comparator Busulfan Small molecule 12.8 mg/kg
Subject Melphalan Small molecule 140 mg/m2
Background Fludarabine Small molecule 150 mg/m2