Back to results

Treatment of Chronic GVHD of Liver or Lungs by ECP

Primary Purpose

Chronic Graft-Versus Host Disease

Status

Unknown status

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Extracorporeal photoimmunotherapy

About this trial

This is an interventional treatment trial for Chronic Graft-Versus Host Disease focused on measuring hematopoietic stem cell transplantation, graft-versus-host disease, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

Medical University of Vienna, Department of Medicine I, BMTRecruiting

Outcomes

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

Full Information

NCT ID

NCT00271869

First Posted

January 3, 2006

Last Updated

January 3, 2006

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00271869

Brief Title

Treatment of Chronic GVHD of Liver or Lungs by ECP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2005

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Graft-Versus Host Disease

Keywords

hematopoietic stem cell transplantation, graft-versus-host disease, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Extracorporeal photoimmunotherapy

Primary Outcome Measure Information:

Title

GVHD response of the liver or lungs

Secondary Outcome Measure Information:

Title

transplant-related mortality

Title

relapse-free survival

Title

overall survival

Title

time to complete resolution of chronic GVHD to first-line immunosuppressive therapy

Title

time to discontinuation of immunosuppressive therapy

Title

duration of response to first-line immunosuppressive therapy

Title

percentage of patients in need of secondary treatment for chronic GVHD

Title

incidence of bacterial, viral and fungal infections

Title

side effects of ECP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hildegard T Greinix, MD

Phone

43-1-40400

Ext

4457

hildegard.greinix@meduniwien.ac.at

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Zielinski, MD

Phone

43-1-40400

Ext

4457

christoph.zielinski@meduniwien.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hildegard T Greinix, Professor of Medicine

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna, Department of Medicine I, BMT

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hildegard T Greinix, Professor of Medicine

Phone

43-1-40400

Ext

4457

hildegard.greinix@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Hildegard T Greinix, Professor of Medicine

12. IPD Sharing Statement

Learn more about this trial

Treatment of Chronic GVHD of Liver or Lungs by ECP

We'll reach out to this number within 24 hrs