Clinical Trial

Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Enrolling by Invitation Phase 3
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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.
Summary
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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-01-05.
Status change: Recruiting → Enrolling by Invitation 2025-02-05
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 2023-02-15
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-10