Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Graft-versus-Host Disease	Drug: Methoxsalen; Procedure: Extracorporeal Photopheresis	Phase 2

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.

Study Design

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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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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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, 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

Sponsors and Collaborators

Mallinckrodt

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37.

Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11. Erratum in: Blood. 2009 Apr 30;113(18):4478.

ClinicalTrials.gov Identifier:	NCT00054613 History of Changes
Other Study ID Numbers:	GvHD-SK1
First Posted:	February 6, 2003
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