Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

This study has been completed.
Sponsor:
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00054613
First received: February 5, 2003
Last updated: April 7, 2010
Last verified: April 2010

February 5, 2003
April 7, 2010
June 2002
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Complete list of historical versions of study NCT00054613 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Graft-Versus-Host Disease
  • Drug: Methoxsalen
  • Procedure: Extracorporeal Photopheresis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
March 2004
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Inclusion Criteria:

  • Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
  • Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
  • Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
  • Patients must weight at least 40 kg (88 lbs.)

Exclusion Criteria:

  • Active gastrointestinal bleeding
  • Previous treatment with ECP
  • Females who are pregnant and/or lactating
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   France,   Germany,   Italy,   Portugal,   Slovakia,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT00054613
GvHD-SK1
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Therakos
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Therakos
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP