Treatment of Chronic GVHD of Liver or Lungs by ECP

Medical University of Vienna20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Graft-Versus Host Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

GVHD response of the liver or lungs

Secondary Outcomes

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