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

Graft-versus-Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054613
• Other study ID #: GvHD-SK1
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: August 14, 2017
• Start date: June 2002
• Est. completion date: March 2004

Study information

• Verified date: August 2017
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-Host Disease

Intervention

Drug:
• Methoxsalen

Procedure:
• Extracorporeal Photopheresis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Italy,  Portugal,  Slovakia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (2)

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. Review. — View 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. — View Citation