NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING
- Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related
donor hematopoietic stem cell transplantation after a reduced-intensity conditioning
regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and
methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid
tumors, or other diseases.
- Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on
days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and
methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4
hours on days -4 to -1.
- Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood
stem cells IV over 1 hour on days 0 and 1.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4
hours or orally twice daily beginning on day -1 and continuing until day 60, followed
by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4,
7, and 12.
After the transplant, patients are followed periodically.
Masking: Open Label, Primary Purpose: Treatment
Engraftment (neutrophil, platelet, and red blood cells)
Kyoo H. Lee, MD
Asan Medical Center
United States: Federal Government