CTL019 in patients with refractory or relapsed non-hodgkins lymphoma
Research type
Research Study
Full title
Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA).
IRAS ID
256235
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
Trial Monitoring Organisation (TMO)
Eudract number
2016-002966-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 4 days
Research summary
Most patients with aggressive B-cell Non-Hodgkins Lymphoma (NHL)- also known as diffuse large B-cell lymphoma (DLBCL), can be cured with conventional frontline immunochemotherapy (e.g. R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)), however around one-third of patients will not respond or will relapse or progress after front-line treatment.
More than half of all these treatment failures include patients not responding (refractory) or relapsing/progressing within a year after the standard frontline immunochemotherapy. These patients have a poor prognosis, particularly if they do not respond to further immunochemotherapy or are not eligible for stem cell transplantation.
This is a phase III, dual arm, mulicentre open label trial to determine the efficacy and safety of tisadenlecleucel (CTL019) in adult patients with refractory or relapsed aggressive B-cell NHL.
The purpose of this study is to evaluate the efficacy of tisagenlecleucel therapy compared to standard of care (SOC) therapy to delaying disease progression/stable disease at or after 12 weeks of treatment; or death at any time.
The study has the following phases:
Screening
Pre-treatment
Treatment
Follow upEfficacy and safety will be evaluated for 5 years post-treatment.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0858
Date of REC Opinion
29 Nov 2019
REC opinion
Further Information Favourable Opinion