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Treatment of Chronic GVHD of Liver or Lungs by ECP

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Medical University of Vienna.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: January 4, 2006
Last Update Posted: January 4, 2006
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.
Information provided by:
Medical University of Vienna
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.

Condition Intervention Phase
Chronic Graft-Versus Host Disease Procedure: Extracorporeal photoimmunotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • GVHD response of the liver or lungs

Secondary Outcome Measures:
  • transplant-related mortality
  • relapse-free survival
  • overall survival
  • time to complete resolution of chronic GVHD to first-line immunosuppressive therapy
  • time to discontinuation of immunosuppressive therapy
  • duration of response to first-line immunosuppressive therapy
  • percentage of patients in need of secondary treatment for chronic GVHD
  • incidence of bacterial, viral and fungal infections
  • side effects of ECP

Estimated Enrollment: 20
Study Start Date: December 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Signed written informed consent

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00271869

Contact: Hildegard T Greinix, MD 43-1-40400 ext 4457 hildegard.greinix@meduniwien.ac.at
Contact: Christoph Zielinski, MD 43-1-40400 ext 4457 christoph.zielinski@meduniwien.ac.at

Medical University of Vienna, Department of Medicine I, BMT Recruiting
Vienna, Austria, A-1090
Contact: Hildegard T Greinix, Professor of Medicine    43-1-40400 ext 4457    hildegard.greinix@meduniwien.ac.at   
Principal Investigator: Hildegard T Greinix, Professor of Medicine         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Hildegard T Greinix, Professor of Medicine Medical University of Vienna
  More Information

ClinicalTrials.gov Identifier: NCT00271869     History of Changes
Other Study ID Numbers: EK Nr. 368/2005
First Submitted: January 3, 2006
First Posted: January 4, 2006
Last Update Posted: January 4, 2006
Last Verified: December 2005

Keywords provided by Medical University of Vienna:
hematopoietic stem cell transplantation
graft-versus-host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases