EpcoReal: A prospective observational study of epcoritamab in DLBCL
Research type
Research Study
Full title
EpcoReal: A multi-country, prospective observational study of epcoritamab in NHL comprising two patient cohorts (3L+ [D]LBCL and 3L+ FL)
IRAS ID
352849
Contact name
Christopher Fox
Contact email
Sponsor organisation
AbbVie Ltd
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
This study investigates epcoritamab use in the treatment of Non-Hodgkin Lymphoma, a blood cancer affecting the immune system. In particular, patients who have been told they have (diffuse) large B-Cell lymphoma (DLBCL), and follicular lymphoma (FL) will be asked to participate across multiple countries, although only DLBCL patients will be recruited in the United Kingdom (UK).
Epcoritamab is a treatment for DLBCL and FL that was recently approved in the UK. Clinical trials have shown epcoritamab works well compared to other medications, but currently there is limited information on how it works in everyday clinics. This study will help provide information on how this treatment is used in the real world.
The study aims to describe how well this treatment works, including survival, time the treatment continues to work for the patient, how often patients must visit their doctor or hospital when taking the treatment, and how different treatment combinations are used in the UK overall.
This multi-centre study will be run across ~10 NHS hospital sites in the UK. Doctors will review medical records for DLBCL patients treated with epcoritamab and enter patient information into an online form. This study aims to collect information that will help HCPs understand how well epcoritamab works to treat DLBCL when it is used as part of normal practice. This study will collect data from up to 100 adult DLBCL patients. To be involved in the study, patients must be being treated with epcoritamab and their doctor must have made the decision to prescribe this as part of their normal practice, and not so the patient could take part in this study.
Data will be collected at 8 timepoints across a period of 36 months. HCPs will gather data including patient demographics, medical history, cancer treatment history and medications including epcoritamab dose at different times through the 36 months from the patients’ medical records.
At each study visit, patients will complete surveys on a tablet device to capture patient-reported outcomes through validated measured including the EORTC-QLQ-C30 (33 questions for cancer patients, related to quality of life) and the FACT-Lym (42 questions relating to lymphoma patients wellbeing in several subscales). Information that cannot reveal the patient's identity will be collected, and anonymised in the final database.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/PR/0197
Date of REC Opinion
25 Mar 2025
REC opinion
Further Information Favourable Opinion