Zanubrutinib + Rituximab vs Bendamustine + Rituximab for untreated MCL
Research type
Research Study
Full title
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
IRAS ID
270551
Contact name
Shankara Paneesha
Contact email
Sponsor organisation
BeiGene, Ltd.
Eudract number
2019-000413-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 23 days
Research summary
Mantle cell lymphoma (MCL) is a rare cancer of the lymphatic system that is usually fast-progressing. MCL is often diagnosed at an advanced stage where existing treatments are less effective.
Zanubrutinib is a new drug that is being developed for treatment of MCL. Zanubrutinib blocks a protein called Bruton Tyrosine Kinase (BTK) consequently preventing the growth of the MCL cells. Zanubrutinib displays a highly selective action against BTK and, therefore, it may have fewer side effects than the existing treatments for MCL.
This study is designed to find out how effective zanubrutinib in combination with rituximab is compared to the standard treatment of bendamustine with rituximab in patients with previously untreated MCL who cannot have stem cell transplantation. About 250 patients will be randomised into each of these two groups. Both the patients and their doctors will know the assigned treatment.
Patients in the zanubrutinib with rituximab group will receive both drugs for 6 cycles of 28 days after which they will continue receiving zanubrutinib only. Patients in the standard treatment group will receive bendamustine with rituximab for 6 cycles followed by observation only.
Zanubrutinib capsules will have to be taken by mouth twice a day, every day. Rituximab will be given as an infusion on Day 1 of each cycle. Bendamustine infusions will be given on Days 1 and 2 of each cycle.
Study assessments include evaluation of medical history and use of other medications, recording of side effects, questionnaires, physical examinations, vital signs, endoscopies, ECGs, heart function test (echocardiogram, MUGA, or GHPS), lung function test, blood tests (including hepatitis B and C), pregnancy tests in females, tumour and bone marrow biopsies, PET/CT or MRI scans.
The study will run for about 7 years at around 150 sites in the North America, Europe and Asia-Pacific regions with up to 9 sites in the UK.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0336
Date of REC Opinion
27 Jan 2020
REC opinion
Further Information Favourable Opinion