Effectiveness and safety of CT-P10 in patients with DLBCL
Research type
Research Study
Full title
Clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: an observational study in Europe
IRAS ID
245292
Contact name
Mark Bishton
Contact email
Sponsor organisation
Celltrion Healthcare Hungary Kft.
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 9 months, 9 days
Research summary
This is a European, multi-centre, retrospective, non-interventional post-authorisation safety study (PASS). The study will be conducted in patients diagnosed with diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma (NHL), an uncommon cancer that develops in the lymphatic system.
The study will involve the collection of data from the hospital medical records of patients diagnosed with DLBCL who received treatment with a biosimilar medicine called CT-P10 (also called Truxima). A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already approved for use. Biosimilars may have very slight variations from the original medicine, but they work in the same way. CT-P10 is the first biosimilar version of rituximab (the original medicine) to be approved by the European Medicines Agency (EMA).
The purpose of this study is to find out more about the safety of CT-P10 and how well it works when it is used in real world practice, outside of a clinical trial.
Data for this study will be collected retrospectively from the date of diagnosis of DLBCL until the index date (defined as the start date of CT-P10 treatment), and for a period of 30 months after the index date (or until the patient’s death, if this is sooner).
The study will take place in specialist treatment centres or hospitals which routinely use CT-P10 in DLBCL treatment. It will be conducted in six European countries (in at least two centres per country): the UK, Spain, France, Germany, the Netherlands and Italy.
The population for this study is adult patients with DLBCL who received treatment with CT-P10 as part of their standard clinical care. It is expected to recruit 500 patients.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0867
Date of REC Opinion
11 May 2018
REC opinion
Further Information Favourable Opinion