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ACTIVE NOT RECRUITING
NCT04291261
PHASE2

Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

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

Interventions

DRUG

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