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Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
Sponsor: Shanghai Jiao Tong University School of Medicine
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.
Official title: Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
Key Details
Gender
All
Age Range
16 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2023-10-19
Completion Date
2026-06-30
Last Updated
2025-02-18
Healthy Volunteers
No
Interventions
Fludarabine, busulfan and melphalan
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
Fludarabine and Busulfan
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
Locations (9)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhongshan Hospital, Xianmen University
Xiamen, Fujian, China
923th Hospital PLA
Nanning, Guangxi, China
First Affiliated Hospital of Nanjin Medical Unviersity
Nanjin, Jiangsu, China
First Affiliatied Hospital of Soochow University
Suzhou, Jiangsu, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai No10 Hospital
Shanghai, Shanghai Municipality, China
920th Hospital PLA
Kunming, China
Shanghai No 6 Hospital
Shanghai, China