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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


Phase 2
N/A
N/A
Not Enrolling
Both
Graft-Versus-Host Disease

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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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

GvHD-SK1

NCT ID:

NCT00054613

Start Date:

June 2002

Completion Date:

March 2004

Related Keywords:

  • Graft-Versus-Host Disease
  • Graft-versus-Host Disease
  • Extracorporeal Photopheresis
  • Graft vs Host Disease

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of FloridaGainesville, Florida  32610-0277
Tufts New England Medical CenterBoston, Massachusetts  02111
University of ChicagoChicago, Illinois  60637
University of NebraskaOmaha, Nebraska  68198
Kansas City Cancer CenterKansas City, Missouri  64111
Rush Presbyterian - St. Lukes Medical CenterChicago, Illinois  60612
Brigham and WomensBoston, Massachusetts  02115
Jewish HospitalCincinnati, Ohio  45236