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Treatment of Chronic GVHD of Liver or Lungs by ECP

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00271869
First received: January 3, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271869

Contacts
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

Locations
Austria
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
Investigators
Principal Investigator: Hildegard T Greinix, Professor of Medicine Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00271869     History of Changes
Other Study ID Numbers: EK Nr. 368/2005
Study First Received: January 3, 2006
Last Updated: January 3, 2006
Health Authority: Austria: Federal Institute for Drugs and Medicinal Devices

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

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

ClinicalTrials.gov processed this record on May 16, 2013