Treatment of Chronic GVHD of Liver or Lungs by ECP

January 3, 2006 updated by: Medical University of Vienna

Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Recruiting
        • Medical University of Vienna, Department of Medicine I, BMT
        • Contact:
        • Principal Investigator:
          • Hildegard T Greinix, Professor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
GVHD response of the liver or lungs

Secondary Outcome Measures

Outcome Measure
overall survival
relapse-free survival
transplant-related mortality
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Hildegard T Greinix, Professor of Medicine, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 4, 2006

Last Update Submitted That Met QC Criteria

January 3, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK Nr. 368/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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