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

This study has been completed.
Sponsor:
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00054613
First received: February 5, 2003
Last updated: April 7, 2010
Last verified: April 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Therakos:

Estimated Enrollment: 72
Study Start Date: June 2002
Estimated Study Completion Date: March 2004
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054613

  Hide Study Locations
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
Sihhiye, Ankara, Turkey, 6100
United Kingdom
Rotherham General Hospital
Oakwood, Rotherham, Yorkshire, United Kingdom, S60 2UD
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 OS4
Sponsors and Collaborators
Therakos
  More Information

Publications:
Additional 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
Study First Received: February 5, 2003
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Therakos:
Graft-versus-Host Disease
Extracorporeal Photopheresis

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methoxsalen
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014