Chronic Graft-Versus Host Disease
Conditions
Keywords
hematopoietic stem cell transplantation, graft-versus-host disease, treatment
Brief summary
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.
Interventions
PROCEDUREExtracorporeal photoimmunotherapy
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GVHD response of the liver or lungs | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival | — |
| overall survival | — |
| time to complete resolution of chronic GVHD to first-line immunosuppressive therapy | — |
| time to discontinuation of immunosuppressive therapy | — |
| transplant-related mortality | — |
| percentage of patients in need of secondary treatment for chronic GVHD | — |
| incidence of bacterial, viral and fungal infections | — |
| side effects of ECP | — |
| duration of response to first-line immunosuppressive therapy | — |
Countries
Austria
Contacts
Primary ContactHildegard T Greinix, MD
Backup ContactChristoph Zielinski, MD
Outcome results
None listed