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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|University of Florida||Gainesville, Florida 32610-0277|
|Tufts New England Medical Center||Boston, Massachusetts 02111|
|University of Chicago||Chicago, Illinois 60637|
|University of Nebraska||Omaha, Nebraska 68198|
|Kansas City Cancer Center||Kansas City, Missouri 64111|
|Rush Presbyterian - St. Lukes Medical Center||Chicago, Illinois 60612|
|Brigham and Womens||Boston, Massachusetts 02115|
|Jewish Hospital||Cincinnati, Ohio 45236|