Lymphoma Clinical Trial
Official title:
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of
cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the
donor's stem cells. When the healthy stem cells from a donor are infused into the patient
they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,
and platelets. Sometimes the transplanted cells from a donor can make an immune response
against the body's normal cells. Giving cyclosporine and methotrexate before and after
transplant may stop this from happening.
PURPOSE: This clinical trial is studying the side effects and how well donor stem cell
transplant works when given after conditioning therapy in treating patients with hematologic
cancer, recurrent or metastatic solid tumor, or other disease.
OBJECTIVES:
- 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.
OUTLINE:
- 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
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