Actively Recruiting
A Phase 3 Randomized Double-Blind Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Adults With RelapsedRefractory Mantle Cell Lymphoma
Led by BeOne Medicines · Updated on 2026-06-03
300
Participants Needed
152
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining sonrotoclax with zanubrutinib compared to zanubrutinib with placebo in adults who have relapsed or refractory mantle cell lymphoma MCL. This phase 3 randomized, double-blind study aims to determine if sonrotoclax plus zanubrutinib can improve outcomes for patients who have received prior treatments including anti-CD20 monoclonal antibodies or chemoimmunotherapy. The trial is sponsored by BeOne Medicines and includes patients with measurable disease and adequate organ function. Participants are randomly assigned to one of two groups one receives sonrotoclax plus zanubrutinib taken orally, and the other receives a placebo plus zanubrutinib, also taken orally. Treatment continues under blinded conditions to compare the effects of the study drug combination versus placebo. The study includes multiple outcome measures such as progression-free survival, overall survival, response rates, and quality of life assessments over periods ranging from about 41 to 92 months. During the trial, participants will undergo regular assessments including tumor evaluations, laboratory tests, and quality of life questionnaires using specific tools like the EORTC-QLQ-NHL-HG29 and EORTC-QLQ-C30. Safety is closely monitored from the first dose until 30 days after the last dose. The study spans several years, allowing researchers to track long-term outcomes and treatment-emergent side effects while participants continue follow-up visits according to the study schedule.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of mantle cell lymphoma based on WHO 2022 or International Consensus Classification
- Ability to provide archival or fresh tumor tissue for confirmation of diagnosis
- Received 1 to 5 prior systemic therapy lines including anti-CD20 monoclonal antibody or chemoimmunotherapy
- Relapsed or refractory disease after last therapy
- Measurable disease with at least one nodal lesion > 1.5 cm or extranodal lesion > 1 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
You will not qualify if you...
- Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- Prior therapy with BTK degraders
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitors unless intolerant to non-zanubrutinib BTKi
- Prior autologous stem cell transplant or CAR T-cell therapy within 3 months before study drug
- Prior allogeneic stem cell transplant within 6 months before study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before study drug
Research Team
S
Study Director
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