Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
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ClinicalTrials.gov Identifier: NCT00054613 |
Recruitment Status
:
Completed
First Posted
: February 6, 2003
Last Update Posted
: August 16, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft-versus-Host Disease | Drug: Methoxsalen Procedure: Extracorporeal Photopheresis | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2002 |
Study Completion Date : | March 2004 |


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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054613

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, New South Wales | |
St. Vincent's Hospital | |
Darlinghurst, New South Wales, Australia, 2010 | |
Australia | |
Peter MacCallum | |
East Melbourne, Australia | |
Alfred Hospital | |
Melbourne, Australia | |
Royal Melbourne Hospital | |
Parkville, Australia, 3050 | |
Austria | |
General Hospital of Vienna | |
Vienna, Austria, A-1090 | |
France | |
Hopital Edouard Herriot | |
Lyon Cedex 03, France, 69437 | |
Hopital Pitie-Salpetriere | |
Paris, France, F-75013 | |
Germany | |
University of Dresden | |
Dresden, Germany, D-01307 | |
Universitatis Hautklinik | |
Essen, Germany, 45122 | |
Universitatsklinikum Leipzig AOR | |
Leipzig, Germany, D-04103 | |
Ludwig-Maximilians-Universitaet Muenchen | |
Munchen, Germany, D-81377 | |
Italy | |
Careggi Hospital | |
Florence, Italy, 1-50134 | |
San Martino Hospital | |
Genova, Italy, 16132 | |
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 University Medical School | |
Altındağ, Ankara, Turkey, 6100 | |
United Kingdom | |
Rotherham General Hospital | |
Rotherham, Yorkshire, United Kingdom, S60 2UD | |
Glasgow Royal Infirmary | |
Glasgow, United Kingdom, G4 OS4 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00054613 History of Changes |
Other Study ID Numbers: |
GvHD-SK1 |
First Posted: | February 6, 2003 Key Record Dates |
Last Update Posted: | August 16, 2017 |
Last Verified: | August 2017 |
Keywords provided by Mallinckrodt:
Graft-versus-Host Disease Extracorporeal Photopheresis |
Additional relevant MeSH terms:
Graft vs Host Disease Immune System Diseases Methoxsalen Photosensitizing Agents Dermatologic Agents |