Treatment of Chronic GVHD of Liver or Lungs by ECP

Phase 2

• Conditions: Chronic Graft-Versus Host Disease

• Registration Number: NCT00271869
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-12
• Study Start: 2005-12
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Last Update Submitted: 2006-01-03
• Study First Posted: 2006-01-04
• Last Update Posted: 2006-01-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
GVHD response of the liver or lungs

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna, Department of Medicine I, BMT; 🇦🇹 Vienna, Austria