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Treatment of Chronic GVHD of Liver or Lungs by ECP

NCT ID: NCT00271869

Last Updated: 2006-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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

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Conditions

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Chronic Graft-Versus Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Extracorporeal photoimmunotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Hildegard T Greinix, Professor of Medicine

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna, Department of Medicine I, BMT

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Hildegard T Greinix, MD

Role: CONTACT

[email protected]
43-1-40400 ext. 4457

Christoph Zielinski, MD

Role: CONTACT

[email protected]
43-1-40400 ext. 4457

Facility Contacts

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Hildegard T Greinix, Professor of Medicine

Role: primary

[email protected]
43-1-40400 ext. 4457

Other Identifiers

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EK Nr. 368/2005

Identifier Type: -

Identifier Source: org_study_id