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RECRUITING
NCT05991908
PHASE3

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

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

DRUG

Fludarabine, busulfan and melphalan

FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2

DRUG

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