Safety of rapidly infused CT-P10 in patients with NHL or CLL
Research type
Research Study
Full title
The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia: a retrospective non-interventional post-authorisation safety study in Europe
IRAS ID
246199
Contact name
Mark Bishton
Contact email
Sponsor organisation
Celltrion Healthcare Hungary Kft.
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 10 months, 6 days
Research summary
This is a European, multi-centre, retrospective, non-interventional study of patients with non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukaemia (CLL). NHL is an uncommon cancer that develops in the lymphatic system; CLL is a type of cancer affecting the white blood cells.
The study will involve the collection of data from medical records of patients with NHL/CLL 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 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 for use in Europe.
CT-P10 is given by intravenous infusion (slow injection into the body through a vein). To reduce the risk of reactions or side effects, the first infusion is usually given slowly, over 3-4 hours. If no problems are experienced with the first infusion, the second (and subsequent) infusion is sometimes given more quickly, over 90 minutes or less (‘rapid infusion’). This study aims to find out more about the safety of rapidly infused CT-P10 when it is used in real world practice.Data will be collected retrospectively from the date of NHL/CLL diagnosis until the index date (the date of the first rapid CT-P10 infusion), and up to 6 months after the index date.
The study will take place in specialist centres or hospitals which routinely use CT-P10 in the treatment of patients with NHL/CLL. It will be conducted in five European countries: the UK, Spain, France, Italy and the Netherlands. The study population is adults with NHL/CLL who received treatment with rapidly infused CT-P10 as part of their standard clinical care. It is expected to recruit 300 patients.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0851
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion