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PURPOSE: Phase II trial to study the effectiveness of visilizumab in treating patients who have graft-versus-host disease following donor peripheral stem cell transplantation that has not responded to previous treatment.
- Determine the survival rate at 180 days after treatment with visilizumab (Nuvion) as second-line therapy in patients with glucocorticoid-refractory acute graft-versus-host disease after prior allogeneic hematopoietic stem cell transplantation.
- Determine the safety of this drug in these patients.
- Determine the clinical response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive visilizumab (Nuvion) IV for 1-2 doses.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Primary Purpose: Supportive Care
Graft Versus Host Disease
City of Hope Comprehensive Cancer Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:53-0400
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An immunological attack mounted by a graft against the host because of tissue incompatibility when immunologically competent cells are transplanted to an immunologically incompetent host; the resulting clinical picture is that of GRAFT VS HOST DISEASE.
The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.
The immune responses of a host to a graft. A specific response is GRAFT REJECTION.
The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host.
Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.
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