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Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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)
Official title: Reduced Intensity Conditioning With Fludarabine and Busulfan Versus Fludarabine and Melphalan Before Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Randomised, Multi-Center, Phase III Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-02-15
Completion Date
2025-12-30
Last Updated
2025-02-10
Healthy Volunteers
No
Conditions
Interventions
Fludarabine and Busulfan
Fludarabine with total dose of 150 mg/m\^2 in combination with Busulfan with total dose of 6.4 mg/kg
Fludarabine and Melphalan
Fludarabine with total dose of 150 mg/m\^2 in combination with Melphalan with total dose of 140 mg/m\^2
Locations (1)
Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China