Status:
COMPLETED
Donor Stem Cell Transplant After Busulfan, Fludarabine, Methylprednisolone, and Antithymocyte Globulin in Treating Patients With Bone Marrow Failure Syndrome
Lead Sponsor:
Asan Medical Center
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from re...
Detailed Description
OBJECTIVES: * To evaluate the efficacy of HLA-haploidentical familial donor hematopoietic stem cell transplantation after reduced-intensity conditioning regimen comprising busulfan, fludarabine phosp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of any of the following bone marrow failure syndromes:
- Severe aplastic anemia, meeting 1 of the following criteria:
- Not responsive to immunosuppressive therapy
- With recurrent cytopenia after immunosuppressive therapy or allogeneic hematopoietic cell transplantation
- Low-risk myelodysplastic syndrome, including any of the following:
- Refractory anemia
- Refractory anemia with ringed sideroblasts
- Refractory cytopenia with multi-lineage dysplasia
- Paroxysmal nocturnal hemoglobinuria, meeting 1 of the following criteria:
- With thrombotic episodes
- With severe cytopenia
- No willing, suitable HLA-compatible donor in family or in donor registries
- Related donor with HLA-haploidentical mismatch at three or less of 6 loci
- Patients with very severe neutropenia (\< 200/μL) or febrile episodes, who feel urgent need for allogeneic hematopoietic cell transplantation, are eligible without a search for HLA-matched unrelated donors
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin \< 2.0 mg/dL
- AST \< 3 times upper limit of normal
- Creatinine \< 2.0 mg/dL
- Ejection fraction \> 40% by MUGA scan
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00731328
Start Date
April 1 2008
End Date
December 1 2013
Last Update
December 31 2015
Active Locations (1)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736