Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematological Cancer
NCT00627666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2013-03-26
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 rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methotrexate after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together with busulfan, fludarabine, and antithymocyte globulin works in treating patients with hematological cancer.
Conditions
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
Interventions
- BIOLOGICAL
-
anti-thymocyte globulin
- DRUG
-
busulfan
- DRUG
-
fludarabine phosphate
- DRUG
-
leucovorin calcium
- DRUG
-
methotrexate
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
- PROCEDURE
-
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Sponsors & Collaborators
-
Asan Medical Center
lead OTHER
Principal Investigators
-
Kyoo H. Lee, MD · Asan Medical Center
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 15 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-01-31
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- South Korea
Study Locations
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