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Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

2014-08-27 03:55:28 | BioPortfolio

Summary

The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

Description

For patients who survive allogeneic bone marrow transplants greater than 100 days, chronic GvHD is a major cause of non-relapse morbidity and mortality. Depending on the presence of known associated risk factors, chronic GvHD will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%.

Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD, suppression of these cells by means other than medications could have benefit in the GvHD population.

ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations.

The purpose of this study is to determine whether ECP, in conjunction with standard therapy, is effective in the treatment of chronic GvHD. Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Graft-Versus-Host Disease

Intervention

Methoxsalen, Extracorporeal Photopheresis

Location

University of Arkansas for Medical Sciences
Little Rock
Arkansas
United States
72205

Status

Completed

Source

Therakos

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:28-0400

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PubMed Articles [21556 Associated PubMed Articles listed on BioPortfolio]

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).

Mini photopheresis for refractory chronic graft-versus-host disease in children and adolescents.

Extracorporeal photopheresis (ECP) has been established to treat graft-versus-host disease. Our mini ECP technique (mini-ECP) allows for treatment of patients with GVHD and contraindications for class...

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.

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Extracorporeal photopheresis is a valuable treatment option in steroid-refractory or steroid-dependent acute graft versus host disease-experience with three different approaches.

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

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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.

A process in which peripheral blood is exposed in an extracorporeal flow system to photoactivated 8-methoxypsoralen (METHOXSALEN) and ultraviolet light - a procedure known as PUVA THERAPY. Photopheresis is at present a standard therapy for advanced cutaneous T-cell lymphoma; it shows promise in the treatment of autoimmune diseases.

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.

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