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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054613
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : August 16, 2017
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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 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00054613

  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, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Peter MacCallum
East Melbourne, Australia
Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia, 3050
General Hospital of Vienna
Vienna, Austria, A-1090
Hopital Edouard Herriot
Lyon Cedex 03, France, 69437
Hopital Pitie-Salpetriere
Paris, France, F-75013
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
Careggi Hospital
Florence, Italy, 1-50134
San Martino Hospital
Genova, Italy, 16132
Instituto Portugues de Oncologia de Francisco Gentil
Lisboa, Portugal, 1099-023
Klinika hematologie a transfuziologie FN
Bratislava, Slovakia, 81103
Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
Barcelona, Spain, E-08025
Kantonsspital Basel
Basel, Switzerland, CH-4031
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