Leukemia Clinical Trial
Official title:
HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING OF BUSULFAN, FLUDARABINE, AND ANTI-THYMOCYTE GLOBULIN FOR PATIENTS WITH BONE MARROW FAILURE SYNDROME - A PHASE 2 STUDY
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 rejecting the donor's stem cells. The donated stem cells may replace the
patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor
effect).
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after
busulfan, fludarabine, methylprednisolone, and antithymocyte globulin in treating patients
with bone marrow failure syndrome.
OBJECTIVES:
- To evaluate the efficacy of HLA-haploidentical familial donor hematopoietic stem cell
transplantation after reduced-intensity conditioning regimen comprising busulfan,
fludarabine phosphate, and anti-thymocyte globulin in patients with bone marrow failure
syndromes.
OUTLINE:
- Reduced-intensity conditioning regimen: Patients receive busulfan IV daily on days -7
and -6, fludarabine phosphate IV over 30 minutes on days -7 to -2, anti-thymocyte
globulin (ATG) IV over 4 hours on days -4 to -1, and methylprednisolone IV over 30
minutes starting 30 minutes before ATG on days -4 to -1.
- HLA-haploidentical donor hematopoietic stem cell transplantation: Patients receive
donor hematopoietic stem cells via Hickman catheter over 1 hour on days 0 or 1.
- Graft-versus-host-disease prophylaxis (GVHD): Patients receive cyclosporine IV over 2-4
hours every 12 hours starting on day -1 (cyclosporine can be given orally once oral
medication can be tolerated) and methotrexate IV on days 2, 4 , 7, and 12. In the
absence of GVHD, cyclosporine is tapered starting between days 30 to 60.
After completion of study treatment, patients are followed periodically for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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