Trial Information

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.