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

Completed · Phase 2

Conditions studied: Graft-versus-Host Disease

In brief

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).

Key facts

Study ID

NCT00054613

Run by

Mallinckrodt

People needed

72

Starts

2002-06-01

Expected to finish

2004-03-01

Last updated by the study team

2017-08-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• Active gastrointestinal bleeding
• Previous treatment with ECP
• Females who are pregnant and/or lactating

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of Florida — Gainesville, Florida, United States
• Rush Presbyterian - St. Lukes Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Brigham and Womens — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Kansas City Cancer Center — Kansas City, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Jewish Hospital — Cincinnati, Ohio, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Peter MacCallum — East Melbourne, Australia
• Alfred Hospital — Melbourne, Australia
• Royal Melbourne Hospital — Parkville, Australia
• General Hospital of Vienna — Vienna, Austria
• Hopital Edouard Herriot — Lyon, France
• Hopital Pitie-Salpetriere — Paris, France
• University of Dresden — Dresden, Germany
• Universitatis Hautklinik — Essen, Germany
• Universitatsklinikum Leipzig AOR — Leipzig, Germany
• Ludwig-Maximilians-Universitaet Muenchen — München, Germany
• Careggi Hospital — Florence, Italy
• San Martino Hospital — Genova, Italy
• Instituto Portugues de Oncologia de Francisco Gentil — Lisbon, Portugal

Full record on ClinicalTrials.gov

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