Lymphoma Clinical Trial
Official title:
Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide,
together with antithymocyte globulin before a donor stem cell transplant helps stop the
growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also
stops 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 and
abnormal 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
mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well stem cell transplant works in treating
patients with hematological cancer or other disorders.
OBJECTIVES:
Primary
- Evaluate the incidence of graft acceptance in patients with hematological disorders
treated with combined immunosuppression before and after HLA-haploidentical
hematopoietic stem cell transplantation.
Secondary
- Evaluate efficacy of this regimen in these patients.
- Evaluate toxicity of this regimen in these patients.
- Assess survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to
-1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.
- Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on
day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF)
beginning on day 4 and continuing until blood counts recover.
- Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing
for 6 months and mycophenolate mofetil 4 times a day on days 4-84.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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