Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal photoimmunotherapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| GVHD response of the liver or lungs |
| Measure | Description | Time Frame |
|---|---|---|
| transplant-related mortality | ||
| relapse-free survival | ||
| overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hildegard T Greinix, MD | Contact | 43-1-40400 | 4457 | hildegard.greinix@meduniwien.ac.at |
| Christoph Zielinski, MD | Contact | 43-1-40400 | 4457 | christoph.zielinski@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Hildegard T Greinix, Professor of Medicine | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Medicine I, BMT | Recruiting | Vienna | A-1090 | Austria |
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D007154 | Immune System Diseases |