Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated February 18, 2025 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-14; most recent amendment 2025-02-14.
Status change: Active, Not Recruiting → Recruiting 2023-10-21
Trial Details
NCT Number NCT05991908
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 222 participants
Start Date 2023-10-19
Primary Completion 2025-10-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-18