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Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease

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

Summary

The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).

Description

Approximately 30% of HLA-identical related bone marrow graft recipients and up to 90% of patients receiving bone marrow from unrelated donors develop significant acute GvHD despite the use of prophylactic therapies such as cyclosporine and methotrexate. About half of these patients respond to initial treatment with steroids and require no further treatment. The remainder of these patients are either unresponsive to initial therapy or become steroid-resistant over time. The prognosis in these cases is poor and mortality for patients with steroid-resistant GvHD may be as high as 50%.

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. ECP has shown activity in several inflammatory and autoimmune diseases, including scleroderma, rheumatoid arthritis, transplantation rejection, acute and chronic GvHD.

In a previous single-center, open label, single-arm study of 56 patients receiving ECP treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to bone marrow transplantation from matched or partially matched human donors, the incidence of grade II-IV acute GvHD was less than 10%. This is in contrast to an expected incidence of approximately 40%.

The purpose of this study is to determine the role of ECP, administered pre-transplant, in preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Graft-Versus-Host Disease

Intervention

Methoxsalen, Extracorporeal Photopheresis

Location

University of Florida
Gainesville
Florida
United States
60637

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 [21716 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).

A pediatric case of squamous cell cancer in situ in the setting of sclerodermatous graft-versus-host disease and voriconazole treatment.

Sclerodermatous graft-versus-host disease is a subtype of cutaneous chronic graft-versus-host disease that is characterized by sclerosis of the skin and subcutaneous tissue, resulting in debilitating ...

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

Extracorporeal photopheresis.

During the treatment of extracorporeal photopheresis (ECP), white blood cells are collected by apheresis and exposed to ultraviolet A after incubation with 8-methoxypsoralen. Although ECP was first de...

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...

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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