At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sonrotoclax (drug), Zanubrutinib (drug), Placebo (drug)
- How long the study runs
- Study runs about 84 months (dates as stated)
- About the drug or intervention
- Sonrotoclax — drug: Administered orally · Zanubrutinib — drug: Administered orally · Placebo — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2025-03-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for mantle cell lymphoma
- • Phase3 - 300 participants
- • The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with mantle cell lymphoma
Where?
- • Birmingham - Birmingham Heartlands Hospital
- • Bournemouth - The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
- • Glasgow - Beatson West of Scotland Cancer Centre
- • Headington - Oxford University Hospitals Nhs Trust Churchill Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
More detail
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
- ✓Received 1 to 5 previous treatments including an anti-CD20 monoclonal antibody (mAb)-based treatment that helps your immune system fight cancer...
- ✓Relapsed or refractory disease after the last line of therapy
- ✓cancer that can be measured on scans defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that...
- ✓activity scale (ECOG) Performance Status of 0 to 2
Who cannot take part
- ✗Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- ✗Prior therapy with BTK degraders
- ✗Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first...
- ✗Prior allogeneic stem cell transplant within 6 months of the first dose of the the study treatment
- ✗Known central nervous system involvement by lymphoma
See the full criteria
Where Is This Study? (7 UK sites)
Birmingham Heartlands Hospital
Birmingham B9 5SS, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington OX3 7LE, United Kingdom
University College Hospital
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
How to Get in Touch
Study Director
Sponsor contactCONTACT
