Treatment of Chronic GVHD of Liver or Lungs by ECP
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ClinicalTrials.gov Identifier: NCT00271869
Recruitment Status : Unknown
Verified December 2005 by Medical University of Vienna. Recruitment status was: Recruiting
Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
Presence of liver or lung manifestations of chronic GVHD
Indication for systemic immunosuppressive therapy defined according to NIH consensus
No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
Adequate renal, hepatic, pulmonary and cardiac function
Karnofsky performance score >- 50%
Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study