Actively Recruiting
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-17
120
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shanghai Clinical Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
CONDITIONS
Official Title
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with AML in first remission
- Patients with MDS with bone marrow blast >5% but remain less than 20% before transplantation
- Donor available: HLA matched sibling donor, 9~10/10 matched unrelated donor or haplo-identical donor
- Informed consent provided
You will not qualify if you...
- Patients with active infection (bacterial, fungal, or viral)
- Patients with abnormal liver, renal, or cardiac function
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rui Jin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
Zhaxin Hospital, Go Broad Health Care
Shanghai, Shanghai Municipality, China
Not Yet 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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