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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Aug 1, 2023 to Oct 19, 2023
    • Primary completion date: Jun 30, 2025 to Oct 30, 2025
    • Site details revised at 9 of 9 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05991908
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Myelodysplastic Syndromes
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov