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Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 15, 2025 to Dec 30, 2025 Trial status: Recruiting to Enrolling by Invitation · Completion date: Jun 30, 2025 to Dec 30, 2025 · Start date changed from estimate of Dec 28, 2022 to Feb 15, 2023 · 1 morev2 Show 4 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Completion date: Jun 30, 2025 to Dec 30, 2025
    • Start date changed from estimate of Dec 28, 2022 to Feb 15, 2023
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are: * The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. * The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)
Trial Details
NCT Number NCT05674539
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Acute Myeloid Leukemia, Adult, Myelodysplastic Syndrome(MDS), Allogeneic Hematopoietic Stem Cell Transplantation
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov