NCT00048789

Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Extracorporeal Photopheresis in Graft vs Host Disease in 25 participants. Completed in 29 January 2009.

Timeline

4 November 2002

29 January 2009

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	4 November 2002
Estimated completion	29 January 2009
Sites	1 location across United States

Drugs / interventions tested

• Extracorporeal Photopheresis — full drug profile →

Conditions studied

• Graft vs Host Disease — all drugs for Graft vs Host Disease →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

4 and older, any sex, with Graft vs Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 photographed before starting ECP treatment and once a month during the treatment period. Following baseline tests, participants will undergo treatment and evaluations as follows:

ECP Treatment

Patients will have blood drawn to collect lymphocytes causing GvHD. This may be done with a special needle or catheter (tube inserted into a vein) or for patients who need or prefer it with a temporary central venous catheter similar to that used for the stem cell transplantation. Patients will have three 2- to 3-hour treatments a week for the first week and two treatments a week after that for a total of 25 treatments over 3 months. Patients who do not tolerate the treatment...

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rippled skin, fasciitis, and joint contractures.
   Patel AR, Avila D, Malech HL, Pavletic SZ, et al · · 2008 · cited 9× · PMID 19022104 · DOI 10.1016/j.jaad.2008.08.023
2. Extracorporeal photopheresis versus alternative treatment for chronic graft-versus-host disease after haematopoietic stem cell transplantation in children and adolescents.
   Buder K, Zirngibl M, Bapistella S, Meerpohl JJ, et al · · 2022 · cited 2× · PMID 35679154 · DOI 10.1002/14651858.cd009898.pub4
3. Extracorporeal photophoresis: an evidence-based analysis.
   Medical Advisory Secretariat. · · 2006 · cited 1× · PMID 23074497