Status:
COMPLETED
Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematological Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the growth of cancer cells. Chemotherapy and antithymocyte globulin stop the patient's immune system from reje...
Detailed Description
OBJECTIVES: * To investigate whether unrelated donor hematopoietic stem cell transplantation using a nonmyeloablative conditioning regimen comprising busulfan, fludarabine phosphate, and anti-thymocy...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of any 1 of the following:
- Acute leukemia
- Chronic myelogenous leukemia
- Myelodysplastic syndromes
- Must have an unrelated donor available who is matched for HLA-A and -B by serology and for DRB1 by molecular typing
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin \< 3.0 mg/dL
- Creatinine \< 2.0 mg/dL
- AST and ALT \< 3 times the upper limit of normal
- Not pregnant or nursing
- Ejection fraction ≥ 45% by MUGA scan or ECHO
- No major illness or organ failure
- No severe psychiatric disorder or mental deficiency that makes compliance with the treatment unlikely and informed consent impossible
- PRIOR CONCURRENT THERAPY:
- Not specified
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00627666
Start Date
January 1 2003
End Date
June 1 2010
Last Update
March 26 2013
Active Locations (1)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736