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

August 14, 2017 updated by: Mallinckrodt

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia
        • Peter MacCallum
      • Melbourne, Australia
        • Alfred Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
  • Austria
      • Vienna, Austria, A-1090
        • General Hospital of Vienna
  • France
      • Lyon Cedex 03, France, 69437
        • Hôpital Edouard Herriot
      • Paris, France, F-75013
        • Hôpital Pitié-Salpétrière
  • Germany
      • Dresden, Germany, D-01307
        • University of Dresden
      • Essen, Germany, 45122
        • Universitatis Hautklinik
      • Leipzig, Germany, D-04103
        • Universitatsklinikum Leipzig AOR
      • Munchen, Germany, D-81377
        • Ludwig-Maximilians-Universitaet Muenchen
  • Italy
      • Florence, Italy, 1-50134
        • Careggi Hospital
      • Genova, Italy, 16132
        • San Martino Hospital
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Instituto Portugues de Oncologia de Francisco Gentil
  • Slovakia
      • Bratislava, Slovakia, 81103
        • Klinika hematologie a transfuziologie FN
  • Spain
      • Barcelona, Spain, E-08025
        • Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
  • Switzerland
      • Basel, Switzerland, CH-4031
        • Kantonsspital Basel
  • Turkey
    • Ankara
      • Altındağ, Ankara, Turkey, 6100
        • Ankara University Medical School
  • United Kingdom
      • Glasgow, United Kingdom, G4 OS4
        • Glasgow Royal Infirmary
    • Yorkshire
      • Rotherham, Yorkshire, United Kingdom, S60 2UD
        • Rotherham General Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Lukes Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Womens
      • Boston, Massachusetts, United States, 02111
        • Tufts New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0914
        • University of Michigan
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Jewish Hospital
    • Washington
      • Seattle, Washington, United States, 19024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GvHD-SK1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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