Clinical trial NCT00054613: Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft-versus-Host Disease
Keywords: Graft-versus-Host Disease
Extracorporeal Photopheresis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2003-02-06
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - St. Lukes Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Cincinnati
country: United States
facility: Jewish Hospital
state: Ohio
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: East Melbourne
country: Australia
facility: Peter MacCallum
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Vienna
country: Austria
facility: General Hospital of Vienna
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Dresden
country: Germany
facility: University of Dresden
city: Essen
country: Germany
facility: Universitatis Hautklinik
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AOR
city: Munchen
country: Germany
facility: Ludwig-Maximilians-Universitaet Muenchen
city: Florence
country: Italy
facility: Careggi Hospital
city: Genova
country: Italy
facility: San Martino Hospital
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil
city: Bratislava
country: Slovakia
facility: Klinika hematologie a transfuziologie FN
city: Barcelona
country: Spain
facility: Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
city: Basel
country: Switzerland
facility: Kantonsspital Basel
city: Altındağ
country: Turkey
facility: Ankara University Medical School
state: Ankara
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospital
state: Yorkshire
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
Study officials:
References:
citation: 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.
citation: Greinix 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.
citation: Flowers 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.