ECP Combination Study
Research type
Research Study
Full title
Multi-centre retrospective study to describe the use and outcomes of ECP in combination with new treatment protocols in Acute and Chronic GvHD
IRAS ID
302468
Contact name
Emmanuelle Polge
Contact email
Sponsor organisation
European society for Blood and Marrow Transplantation
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Graft versus host disease (GvHD) is one of the major complications of allogeneic stem cell transplantation. GvHD may be either acute (aGVHD) or chronic (cGvHD). Most patients with GvHD are treated with steroids however optimal treatment for patients who fail steroids (steroid refractory (SR) GvHD) is not defined and the published literature regarding the efficacy and tolerability of combination treatment is sparse.
This is a retrospective multi-centre registry based study the primary purpose of which is to compare and evaluate the safety and efficacy of extracorporeal photopheresis (ECP) and/or new treatments (such as Ibrutinib and Ruxolitinib) as treatment for steroid SR-GvHD.
The study period covers 2017-2020.
Participants will be identified from the European Society for Blood and Marrow Transplantation (EBMT) database at participating centres. The study population will be patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) and have developed SR-GvHD treated with ECP either alone or in combination with ruxolitinib or ibrutinib.The primary purpose of the study is to assess the response rates to GvHD treatment. This will analyse the type of patients selected for combination treatment, and investigate whether combinations provide better responses, as well as any effects on the de-escalation of steroids, as well as on the occurrence of complications and infections.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0329
Date of REC Opinion
16 Sep 2021
REC opinion
Favourable Opinion