Chronic Graft-Versus Host Disease Clinical Trial
Official title:
Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna, Department of Medicine I, BMT | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | GVHD response of the liver or lungs | |||
| Secondary | transplant-related mortality | |||
| Secondary | relapse-free survival | |||
| Secondary | overall survival | |||
| Secondary | time to complete resolution of chronic GVHD to first-line immunosuppressive therapy | |||
| Secondary | time to discontinuation of immunosuppressive therapy | |||
| Secondary | duration of response to first-line immunosuppressive therapy | |||
| Secondary | percentage of patients in need of secondary treatment for chronic GVHD | |||
| Secondary | incidence of bacterial, viral and fungal infections | |||
| Secondary | side effects of ECP |