Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
- Conditions
- Graft-versus-Host Disease
- Registration Number
- NCT00054613
- Lead Sponsor
- Mallinckrodt
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
- Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
- Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
- Patients must weight at least 40 kg (88 lbs.)
- Active gastrointestinal bleeding
- Previous treatment with ECP
- Females who are pregnant and/or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
University of Florida
๐บ๐ธGainesville, Florida, United States
University of Nebraska
๐บ๐ธOmaha, Nebraska, United States
Ankara University Medical School
๐น๐ทAltฤฑndaฤ, Ankara, Turkey
General Hospital of Vienna
๐ฆ๐นVienna, Austria
University of Chicago
๐บ๐ธChicago, Illinois, United States
University of Arkansas for Medical Sciences
๐บ๐ธLittle Rock, Arkansas, United States
Rush Presbyterian - St. Lukes Medical Center
๐บ๐ธChicago, Illinois, United States
Ludwig-Maximilians-Universitaet Muenchen
๐ฉ๐ชMunchen, Germany
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Hopital Edouard Herriot
๐ซ๐ทLyon Cedex 03, France
Instituto Portugues de Oncologia de Francisco Gentil
๐ต๐นLisboa, Portugal
Klinika hematologie a transfuziologie FN
๐ธ๐ฐBratislava, Slovakia
San Martino Hospital
๐ฎ๐นGenova, Italy
Kantonsspital Basel
๐จ๐ญBasel, Switzerland
Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
๐ช๐ธBarcelona, Spain
Tufts New England Medical Center
๐บ๐ธBoston, Massachusetts, United States
Kansas City Cancer Center
๐บ๐ธKansas City, Missouri, United States
Jewish Hospital
๐บ๐ธCincinnati, Ohio, United States
Brigham and Womens
๐บ๐ธBoston, Massachusetts, United States
Fred Hutchinson Cancer Research Center
๐บ๐ธSeattle, Washington, United States
Peter MacCallum
๐ฆ๐บEast Melbourne, Australia
Alfred Hospital
๐ฆ๐บMelbourne, Australia
Hopital Pitie-Salpetriere
๐ซ๐ทParis, France
Royal Melbourne Hospital
๐ฆ๐บParkville, Australia
St. Vincent's Hospital
๐ฆ๐บDarlinghurst, New South Wales, Australia
Universitatis Hautklinik
๐ฉ๐ชEssen, Germany
Careggi Hospital
๐ฎ๐นFlorence, Italy
University of Dresden
๐ฉ๐ชDresden, Germany
Universitatsklinikum Leipzig AOR
๐ฉ๐ชLeipzig, Germany
Rotherham General Hospital
๐ฌ๐งRotherham, Yorkshire, United Kingdom
Glasgow Royal Infirmary
๐ฌ๐งGlasgow, United Kingdom