Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Therakos |
---|---|
Information provided by: | Therakos |
ClinicalTrials.gov Identifier: | NCT00054613 |
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).
Condition | Intervention | Phase |
---|---|---|
Graft-Versus-Host Disease |
Drug: Methoxsalen Procedure: Extracorporeal Photopheresis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 72 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | March 2004 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | GvHD-SK1 |
Study First Received: | February 5, 2003 |
Last Updated: | January 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00054613 |
Health Authority: | United States: Food and Drug Administration |
Graft-versus-Host Disease Extracorporeal Photopheresis |
Methoxsalen Graft versus host disease Graft vs Host Disease Homologous wasting disease |
Photosensitizing Agents Radiation-Sensitizing Agents Immune System Diseases Therapeutic Uses |
Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |