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Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation

2014-08-27 03:55:53 | BioPortfolio

Summary

RATIONALE: Visilizumab may suppress the immune system and may be an effective treatment for graft-versus-host disease caused by donor peripheral stem cell transplantation.

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.

Description

OBJECTIVES:

- 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.

Study Design

Primary Purpose: Supportive Care

Conditions

Graft Versus Host Disease

Intervention

visilizumab

Location

City of Hope Comprehensive Cancer Center
Duarte
California
United States
91010-3000

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:53-0400

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PubMed Articles [21491 Associated PubMed Articles listed on BioPortfolio]

Upper gastrointestinal acute graft-versus-host disease adds minimal prognostic value in isolation or with other graft-versus-host disease symptoms as currently diagnosed and treated.

Upper gastrointestinal acute graft-versus-host disease is reported in approximately 30% of hematopoietic stem cell transplant recipients developing acute graft-versus-host disease. Currently classifie...

Post-intestine transplant graft-versus-host disease: Associated with inclusion of a liver graft and with a high mortality risk.

This study reports the incidence, anatomic location, and outcomes of graft-versus-host disease (GVHD) at a single active intestine transplant center.

Update of humanized animal disease models in studying Graft-versus-host disease.

Graft-versus-host disease (GVHD) is a severe adverse effect that results from bone marrow or peripheral blood cells transplantation and has a high rate of mortality. About 50% of the patients are acco...

Resolution of hematocolpos in adolescents affected with Graft Versus Host Disease.

Bone Marrow Transplant (BMT) is a lifesaving procedure for a range of serious benign or malignant hematological conditions. A proportion of patients however will develop Graft Versus Host Disease (GVH...

Extracorporeal Photopheresis: An Efficacious and Well-Tolerated Treatment for Cutaneous and Oral Mucosal Chronic Graft-versus-Host Disease.

Extracorporeal photopheresis (ECP) is a second-line therapy for steroid-refractory chronic graft-versus-host disease (cGVHD).

Medical and Biotech [MESH] Definitions

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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