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

Sponsor
Mallinckrodt (Industry)
Overall Status
Completed
CT.gov ID
NCT00054613
Collaborator
(none)
72
Enrollment
31
Locations
21
Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jun 1, 2002
Study Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Mallinckrodt

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00054613
    Other Study ID Numbers:
    • GvHD-SK1
    First Posted:
    Feb 6, 2003
    Last Update Posted:
    Aug 16, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by , ,
    Graft-versus-Host Disease
    Extracorporeal Photopheresis
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Methoxsalen

    Study Results

    No Results Posted as of Aug 16, 2017