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Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease Clinical research trials and Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease. Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease clinical trial. Subjects typically recieve the finest healthcare available for their Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
For Condition: Graft-Versus-Host Disease
Status: Recruiting
Sponsor(s): Therakos ,
Synopsis: 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).
Details: 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 reacton 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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.) Exclusion Criteria: - Active gastrointestinal bleeding - Previous treatment with ECP - Females who are pregnant and/or lactating
Total Enrollment: 72
Location and Contact Information:
Jewish Hospital *Not yet recruiting*
Cincinnati, Ohio, 45236
United States
Not yet recruiting Kitty Tierney 513-686-5489
University of Dresden *Recruiting*
DRESDEN, , D-01307
Germany
Recruiting Kristina Holig 011-49-351-458-5630
Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona *Not yet recruiting*
Barcelona, , E-08025
Spain
Not yet recruiting Jordi Sierra 34-93-2919396
Peter MacCallum *Not yet recruiting*
East Melbourne, ,
Australia
Not yet recruiting
San Martino Hospital *Not yet recruiting*
Genova, , 16132
Italy
Not yet recruiting
Universitatsklinikum Leipzig AOR *Not yet recruiting*
Leipzig, , D-04103
Germany
Not yet recruiting
Royal Melbourne Hospital *Recruiting*
Parkville, , 3050
Australia
Recruiting
Brigham and Womens *Not yet recruiting*
Boston, Massachusetts, 02115
United States
Not yet recruiting
Kantonsspital Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting
Rush Presbyterian - St. Lukes Medical Center *Not yet recruiting*
Chicago, Illinois, 60612
United States
Not yet recruiting Annette Morales 312-942-2197
Universitatis Hautklinik *Not yet recruiting*
ESSEN, , 45122
Germany
Not yet recruiting
University of Florida *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting
Tufts New England Medical Center *Not yet recruiting*
Boston, Massachusetts, 02111
United States
Not yet recruiting Tracy Bell 617-636-5558
University of Nebraska *Not yet recruiting*
Omaha, Nebraska, 68198-7680
United States
Not yet recruiting Philip Bierman 402-559-5520
Hopital Pitie-Salpetriere *Not yet recruiting*
Paris, , F-75013
France
Not yet recruiting Jean-Paul Vernant 033-1-42-16-02-48
Rotherham General Hospital *Not yet recruiting*
Oakwood, Rotherham, Yorkshire, S60 2UD
United Kingdom
Not yet recruiting Peter Taylor 44-01709-307119
University of Michigan *Not yet recruiting*
Ann Arbor, Michigan, 48109-0914
United States
Not yet recruiting
Alfred Hospital *Not yet recruiting*
Melbourne, ,
Australia
Not yet recruiting
Instituto Portugues de Oncologia de Francisco Gentil *Recruiting*
Lisboa, , 1099-023
Portugal
Recruiting Alexandra Machado 351-21-7229864
Hopital Edouard Herriot *Recruiting*
Lyon Cedex 03, , 69437
France
Recruiting
Careggi Hospital *Not yet recruiting*
Florence, , 1-50134
Italy
Not yet recruiting
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 19024
United States
Recruiting Susan Schumaker 206-667-1392
General Hospital of Vienna *Recruiting*
Vienna, , A-1090
Austria
Recruiting Robert Knobler 011-43-1-40400-770
St. Vincent's Hospital *Not yet recruiting*
Darlinghurst, New South Wales, 2010
Australia
Not yet recruiting
Klinika hematologie a transfuziologie FN *Recruiting*
Bratislava, , 81103
Slovakia
Recruiting Martin Mistrik 421 2 5441 2255
University of Arkansas for Medical Sciences *Not yet recruiting*
Little Rock, Arkansas, 72205
United States
Not yet recruiting Joan Woodruff
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Patty Migler 773-702-2070
Glasgow Royal Infirmary *Not yet recruiting*
Glasgow, , G4 OS4
United Kingdom
Not yet recruiting
Ludwig-Maximilians-Universitaet Muenchen *Recruiting*
Munchen, , D-81377
Germany
Recruiting
Kansas City Cancer Center *Not yet recruiting*
Kansas City, Missouri, 64111
United States
Not yet recruiting
Ankara University Medical School *Recruiting*
Sihhiye, Ankara, 6100
Turkey
Recruiting
Additional Information:
Study ID Numbers: GvHD-SK1;
Study Start Date: June 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054613
Other Graft-Versus-Host Disease Studies:
1. Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
2. Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease
Related Studies:
Other Graft-Versus-Host Disease Clinical Trials
Other Clinical Trials
Other Glasgow Clinical Trials
Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
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