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

NCT ID: NCT00054613

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2004-03-31

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.

Conditions

Graft-versus-Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Methoxsalen

Intervention Type: DRUG

Extracorporeal Photopheresis

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Locations

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

Klinika hematologie a transfuziologie FN

Bratislava, , Slovakia

Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona

Barcelona, , Spain

Kantonsspital Basel

Basel, , Switzerland

Ankara University Medical School

Altındağ, Ankara, Turkey (Türkiye)

Rotherham General Hospital

Rotherham, Yorkshire, United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Countries

United States; Australia; Austria; France; Germany; Italy; Portugal; Slovakia; Spain; Switzerland; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 9701389 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10784386 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18621929 (View on PubMed)

Other Identifiers

GvHD-SK1

Identifier Type: -

Identifier Source: org_study_id