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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054613
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : August 16, 2017
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Graft-versus-Host Disease Drug: Methoxsalen Procedure: Extracorporeal Photopheresis Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Study Start Date : June 2002
Study Completion Date : March 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054613

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Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00054613    
Other Study ID Numbers: GvHD-SK1
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Mallinckrodt:
Graft-versus-Host Disease
Extracorporeal Photopheresis
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Photosensitizing Agents
Dermatologic Agents