Lymphoma Clinical Trial
Official title:
Randomized Trial of Autologous GVHD for Refractory Lymphoma
RATIONALE: Cyclosporine may induce graft-versus-host disease and make the body build an
immune response that will kill cancer cells. Interleukin-2 and interferon gamma may enhance
the effectiveness of graft-versus-host disease to kill cancer cells.
PURPOSE: Randomized phase III trial to determine the effectiveness of graft-versus-host
disease in treating patients who have recurrent or refractory lymphoma or Hodgkin's disease
.
OBJECTIVES: I. Determine whether autologous graft versus host disease significantly alters
the relapse rate for lymphoma or Hodgkin's disease after autologous bone marrow
transplantation.
OUTLINE: This is a randomized study. Stem cells are harvested and cryopreserved. All
patients receive busulfan/cyclophosphamide or cyclosporine/total body irradiation as a
preparative regimen. Arm I: Patients randomized to the graft versus host disease (GVHD)
induction arm receive oral cyclosporine twice a day beginning on day 0 and continuing for at
least 28 days, followed by peripheral blood stem cell (PBSC) infusion. At the time the white
blood cell count begins to recover, subcutaneous interferon gamma is administered for 10
doses, followed 2 days later by subcutaneous interleukin-2 (IL-2) for 18 doses. Arm II:
Patients do not receive autologous GVHD therapy after the PBSC transplant. Both arms should
receive radiation to the site of lymphoma after recovering from the stem cell
transplantation. Patients are followed at 6 months, 1 year, and 2 years posttransplant.
PROJECTED ACCRUAL: Approximately 50 patients (25 per arm) will be accrued for this study
within 3 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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