Clinical Trial: Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Chronic Graft Versus Host Disease With Extracorporeal Photopheresis
Brief Summary:
This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) for treating chronic graft-versus-host disease (GvHD). GvHD is a common complication of stem cell transplantation using donated stem cells. It occurs when the donor's T-lymphocytes (a type of immune cell) see the patient's cells as foreign and mount an immune response to reject them. The attack can cause skin rash, mouth sores, liver or lung inflammation, lack of appetite, and muscle stiffness. Chronic GvHD can cause serious illness, and even death, from the long-term effects of immune dysfunction and from toxic effects of medications (such as cyclosporine and prednisone) used to treat it.
ECP is an experimental treatment designed to stop the lymphocytes from attacking the body. It involves collecting some of the cells that cause GvHD, treating them with a combination of drug and light therapy and returning them to the body. Sixty to 80 percent of patients with chronic GvHD improve with ECP treatment, and some patients can stop treatment with prednisone or cyclosporine, or reduce the drug dosages.
Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of cyclosporine and prednisone may be eligible for this study. Patients must be able to travel to the NIH Clinical Center in Bethesda, Maryland, twice a week during the 3-month study period.
Upon entering the study, participants will have a baseline evaluation to measure the extent of GvHD. This assessment includes blood tests, eye and dental examinations, skin biopsy for patients with skin involvement, and CT scans and lung function tests to look for possible lung involvement. Biopsies of the lung, liver, mouth, or eye may be requested if needed to confirm GvHD in these tissues. The skin will be photog
Detailed Summary: This is a phase 2 study of extracorporeal photopheresis (ECP) for treatment of chronic graft versus host disease following allogeneic hematopoietic stem cell transplantation. Extracorporeal exposure of human mononuclear cells to ultraviolet A radiation following photosensitization with 8-methoxypsoralen has proven to be an effective treatment for cutaneous T-cell lymphoma. Small, single institution studies have suggested efficacy in other T-cell mediated diseases such as solid organ rejection and graft versus host disease. This a phase 2 study of ECP for treatment of chronic graft versus host disease. Eligible patients must have objective evidence of chronic graft versus host disease that is refractory to conventional therapy or must have steroid-dependent disease that does not permit steroid dose reduction. The primary objective of this study is to better define the safety, efficacy and mechanism of action of ECP for treatment of patients with chronic graft versus host disease.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Determination of response rate including degree of improvement; steroid sparing effect; types of cGVHD problems which respond to this therapy; assessment of problems or side effects or adverse events associated with the procedure.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: November 7, 2002
Date Started: November 4, 2002
Date Completion: January 29, 2009
Last Updated: January 24, 2017
Last Verified: January 29, 2009
