Actively Recruiting
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-18
222
Participants Needed
9
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute myeloid leukemia (excluding acute promyelocytic leukemia) in first complete remission
- Myelodysplasia syndrome with bone marrow blast count over 5% but less than 20% at transplantation
- Patients with HLA matched sibling donor, 9-10 matched unrelated donor, or haplo-identical related donors
- Informed consent provided
You will not qualify if you...
- AML patients with active central nervous system or extramedullary disease
- Patients with active viral, bacterial, or fungal infection
- Patients with hepatitis B virus levels above 1x10^3 copy/ml
- Patients with abnormal liver function, kidney function, respiratory or heart dysfunction
- Patients with uncontrolled mental disorders
- Patients with HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Zhongshan Hospital, Xianmen University
Xiamen, Fujian, China, 361004
Actively Recruiting
3
923th Hospital PLA
Nanning, Guangxi, China, 530021
Actively Recruiting
4
First Affiliated Hospital of Nanjin Medical Unviersity
Nanjin, Jiangsu, China, 210029
Actively Recruiting
5
First Affiliatied Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
6
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
7
Shanghai No10 Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
8
920th Hospital PLA
Kunming, China, 650000
Actively Recruiting
9
Shanghai No 6 Hospital
Shanghai, China
Actively Recruiting
Research Team
C
chun Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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