Treatment of Chronic GVHD of Liver or Lungs by ECP

Medical University of Vienna

Status and phase: Unknown; Phase 2

Conditions: Chronic Graft-Versus Host Disease

Treatments: Procedure: Extracorporeal photoimmunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00271869

EK Nr. 368/2005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)