Status:
UNKNOWN
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
16+ years
Brief Summary
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.
Detailed Description
Conditioning therapy * Busulfan 3.2 mg/kg/d on d-7 to -6 * Fludarabine 30 mg/m2 on d-7 to -2 * ATG 1.5-3.0 mg/kg/d on d-3 to -1 * Methylpred 2 mg/kg/d on d-4 to -1 Mobilization and harvest * Donor ...
Eligibility Criteria
Inclusion
- Patients with higher risk MDS including chronic myelomonocytic leukemia
- RAEB-1 or RAEB-2
- IPSS Intermediate-2 or High risk category
- Chronic myelomonocytic leukemia
- Patients with appropriate hematopoietic cell donor
- HLA-matched sibling
- HLA-matched unrelated donor
- HLA-mismatched familial donor 3.16 years old or older
Exclusion
- • Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01252784
Start Date
November 1 2010
End Date
October 1 2014
Last Update
December 3 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea, 138-736