Status:
COMPLETED
Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematologic Cancer or Myelodysplastic Syndrome
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Pusan National University Hospital
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 cancer and abnormal cells. It may also stop the patient's immune sys...
Detailed Description
OBJECTIVES: * To evaluate the efficacy of HLA-haploidentical familial donor hematopoietic cell transplantation with a reduced-intensity conditioning regimen of busulfan, fludarabine phosphate, and an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematological malignancies:
- Acute leukemia, including any of the following:
- Refractory acute leukemia
- Acute leukemia beyond first remission
- Acute leukemia in first remission with intermediate to poor prognostic features as suggested by chromosomal findings
- Chronic myelogenous leukemia (CML)
- Second chronic phase
- Accelerated phase
- Blastic phase
- Myelodysplastic syndrome (MDS)
- High-risk MDS (refractory anemia with excess blasts \[RAEB\], RAEB in transformation, and chronic myelomonocytic leukemia) can be transplanted without prior therapy or after prior therapy failure with hypomethylating agents
- Low-risk MDS can be considered for transplantation after prior therapy failure with immunosuppressive or hypomethylating agents
- No willing, suitable HLA-matched donor in family or in donor registries
- Patients with active hematologic malignancy, who are felt to be in urgent need of allogeneic hematopoietic cell transplantation, can enroll without a search for HLA-matched unrelated donors
- Related donor with HLA-haploidentical mismatch at 3 or less of 6 loci available
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin \< 2.0 mg/dL
- Creatinine \< 2.0 mg/dL
- AST \< 3 times upper limit of normal
- Ejection fraction \> 40% by MUGA
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00732316
Start Date
April 1 2008
End Date
May 1 2011
Last Update
July 17 2012
Active Locations (1)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736