Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
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
1 other identifier
interventional
72
11 countries
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2002
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 5, 2003
CompletedFirst Posted
Study publicly available on registry
February 6, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedAugust 16, 2017
August 1, 2017
February 5, 2003
August 14, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (31)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of Florida
Gainesville, Florida, 32610, United States
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Tufts New England Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Womens
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109-0914, United States
Kansas City Cancer Center
Kansas City, Missouri, 64111, United States
University of Nebraska
Omaha, Nebraska, 68198-7680, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 19024, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Peter MacCallum
East Melbourne, Australia
Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
General Hospital of Vienna
Vienna, A-1090, Austria
Hopital Edouard Herriot
Lyon, 69437, France
Hopital Pitie-Salpetriere
Paris, F-75013, France
University of Dresden
Dresden, D-01307, Germany
Universitatis Hautklinik
Essen, 45122, Germany
Universitatsklinikum Leipzig AOR
Leipzig, D-04103, Germany
Ludwig-Maximilians-Universitaet Muenchen
München, D-81377, Germany
Careggi Hospital
Florence, 1-50134, Italy
San Martino Hospital
Genova, 16132, Italy
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1099-023, Portugal
Klinika hematologie a transfuziologie FN
Bratislava, 81103, Slovakia
Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
Barcelona, E-08025, Spain
Kantonsspital Basel
Basel, CH-4031, Switzerland
Ankara University Medical School
Altındağ, Ankara, 6100, Turkey (Türkiye)
Rotherham General Hospital
Rotherham, Yorkshire, S60 2UD, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 OS4, United Kingdom
Related Publications (3)
Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37. doi: 10.1016/s1083-8791(98)90007-6.
PMID: 9701389BACKGROUNDGreinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. doi: 10.3109/10428190009148389.
PMID: 10784386BACKGROUNDFlowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11.
PMID: 18621929DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 5, 2003
First Posted
February 6, 2003
Study Start
June 1, 2002
Study Completion
March 1, 2004
Last Updated
August 16, 2017
Record last verified: 2017-08