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| Sponsor: | Therakos |
|---|---|
| Information provided by: | Therakos |
| ClinicalTrials.gov Identifier: | NCT00054613 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Graft-Versus-Host Disease |
Drug: Methoxsalen Procedure: Extracorporeal Photopheresis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-Versus-Host Disease |
| Estimated Enrollment: | 72 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | March 2004 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Illinois | |
| Rush Presbyterian - St. Lukes Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Tufts New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Brigham and Womens | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0914 | |
| United States, Missouri | |
| Kansas City Cancer Center | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, Ohio | |
| Jewish Hospital | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 19024 | |
| Australia | |
| Peter MacCallum | |
| East Melbourne, Australia | |
| Royal Melbourne Hospital | |
| Parkville, Australia, 3050 | |
| Alfred Hospital | |
| Melbourne, Australia | |
| Australia, New South Wales | |
| St. Vincent's Hospital | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Austria | |
| General Hospital of Vienna | |
| Vienna, Austria, A-1090 | |
| France | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| Hopital Pitie-Salpetriere | |
| Paris, France, F-75013 | |
| Germany | |
| University of Dresden | |
| Dresden, Germany, D-01307 | |
| Universitatsklinikum Leipzig AOR | |
| Leipzig, Germany, D-04103 | |
| Universitatis Hautklinik | |
| Essen, Germany, 45122 | |
| Ludwig-Maximilians-Universitaet Muenchen | |
| Munchen, Germany, D-81377 | |
| Italy | |
| San Martino Hospital | |
| Genova, Italy, 16132 | |
| Careggi Hospital | |
| Florence, Italy, 1-50134 | |
| Portugal | |
| Instituto Portugues de Oncologia de Francisco Gentil | |
| Lisboa, Portugal, 1099-023 | |
| Slovakia | |
| Klinika hematologie a transfuziologie FN | |
| Bratislava, Slovakia, 81103 | |
| Spain | |
| Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona | |
| Barcelona, Spain, E-08025 | |
| Switzerland | |
| Kantonsspital Basel | |
| Basel, Switzerland, CH-4031 | |
| Turkey, Ankara | |
| Ankara University Medical School | |
| Sihhiye, Ankara, Turkey, 6100 | |
| United Kingdom | |
| Glasgow Royal Infirmary | |
| Glasgow, United Kingdom, G4 OS4 | |
| United Kingdom, Yorkshire | |
| Rotherham General Hospital | |
| Oakwood, Rotherham, Yorkshire, United Kingdom, S60 2UD | |
More Information
| Study ID Numbers: | GvHD-SK1 |
| Study First Received: | February 5, 2003 |
| Last Updated: | January 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00054613 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Graft-versus-Host Disease Extracorporeal Photopheresis |
|
Photosensitizing Agents Radiation-Sensitizing Agents Immune System Diseases Methoxsalen Therapeutic Uses |
Physiological Effects of Drugs Graft vs Host Disease Dermatologic Agents Pharmacologic Actions |