Clinical Research Directory
Browse clinical research sites, groups, and studies.
Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Summary
This is a single arm phase 2 trial which includes patients with high risk acute GVHD defined as Ann Arbor score 2 or 3. The purpose of the study is to improve the outcome of these patients in terms of response to treatment and treatment related mortality. All patients will receive the study intervention (ECP with Uvadex). The study hypothesis is that the treatment plan will produce a day 28 complete response rate higher than or equal to 52%, which will represent an improvement of 15% compared with the standard of care (37%). The rate of complete response to standard of care treatment is based on observed data in similar patients treated within the Mount Sanai Acute GVHD International Consorium (MAGIC). Patients will be treated for 56 days and followed for one year to also enable evaluation of long term outcome.
Official title: Phase II Multicenter Study of Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2020-05-18
Completion Date
2025-06
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Uvadex
Extracorporeal photopheresis (ECP) with Uvadex is scheduled 3x/week in weeks 1+2, 2x/week thereafter till day 28 and 1x/week till day 56
Locations (4)
Medical University of Graz, Department of Internal Medicine
Graz, Austria
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
University Hospital Erlangen
Erlangen, Germany
University Medical Center Regensburg
Regensburg, Germany