CTL019 in patients with refractory or relapsed follicular lymphoma
Research type
Research Study
Full title
A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma
IRAS ID
247865
Contact name
Ram Malladi
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-004385-94
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 19 days
Research summary
This is a study to find out if the investigational therapy tisagenlecleucel (also referred to as CTL019, CART-19 or Kymriah®) is safe and has beneficial effects in people who have follicular lymphoma.
The purpose of the study is to test an experimental approach called modified T cell therapy for follicular lymphoma. T cells (a type of white blood cell) will be removed from a patient’s blood and modified in order to target follicular lymphoma and then returned back to the patient. The T cells will be changed in a way that can allow them to identify and possibly kill a patient’s B cells (another type of white blood cell) including follicular lymphoma tumour cells.
The benefits are not established. Treatment may help keep a patient’s disease in remission or there may be no benefit.
Adult patients with follicular lymphoma may be suitable to take part.
Patients will receive one dose of tisagenlecleucel administered by intravenous infusion.
Patients will be participate in the study until all patients have completed their 2 years of follow-up (range from 2 years to 3.5-4 years).
The study is made up of the following visits:
Screening
Leukapheresis
Pre-treatment phase which includes the enrolment and pre-lymphodepletion evaluation visit, lymphodepleting chemotherapy visit (if applicable) and pre-infusion visit
Tisagenlecleucel infusion visit
Post-tisagenlecleucel infusion visits
Survival contacts
Patients will visit the hospital several times prior to receiving tisagenlecleucel. After infusion, patients will visit the hospital every few days for the first month and then each month for the first 6 months. Then at months 9, 12, 18, 24 and every 6 months until the last patient has completed 2 year follow-up. The approximate total number of visits will be 26.
The study is being organised and funded by Novartis Pharma AG and is being run by medical staff in hospitals.REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0528
Date of REC Opinion
7 Mar 2019
REC opinion
Further Information Favourable Opinion