A study of paediatric patients with non-Hodgkins lymphoma
Research type
Research Study
Full title
A Phase II, single arm, multicentre, open label trial to determine the safety and efficacy of tisagenlecleucel in paediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL).
IRAS ID
253086
Contact name
Sara Ghorashian
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2017-005019-15
Clinicaltrials.gov Identifier
EMEA-001654-PIP02-17,
Duration of Study in the UK
3 years, 6 months, 11 days
Research summary
This is an open-label, single arm 2 year study, the purpose of which is to test an experimental approach called modified T-cell therapy, to see if it is safe and will help with the treatment of children and adolescents with non-Hodgkins lymphoma(NHL). In this study, T cells (a type of white blood cell) will be removed from the patient's blood using a process called 'leukapheresis', modified in order to target the lymphoma, and then returned back to them. The T cells will be changed in a way that can allow them to identify and possibly kill the patient’s NHL tumour cells.
The modification of the T cells is done by a process called gene transfer which results in a genetic modification to the T cells taken from the patient's body. These modified T cells are called tisagenlecleucel cells and they will be administered to the patient by intravenous infusion approximately six weeks later. Patients then enter a follow up period of around two years during which they have regular blood tests performed and well as ongoing assessment of their disease status.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0375
Date of REC Opinion
4 Nov 2019
REC opinion
Further Information Favourable Opinion