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)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Mantle Cell Lymphoma, B Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT06742996
- Run by
- BeOne Medicines
- People needed
- 300
- Starts
- 2025-03-05
- Expected to finish
- 2032-03-30
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
- Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- Relapsed or refractory disease after the last line of therapy
- Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate organ function
You may not qualify if…
- Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- Prior therapy with BTK degraders
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
- University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
- Ucsf Fresno — Fresno, California, United States (enrolling)
- Kaiser Permanente Southern California — Irvine, California, United States (enrolling)
- Yale University Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Memorial Cancer Institute, Memorial Healthcare System — Pembroke Pines, Florida, United States (enrolling)
- Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
- Mission Cancer and Blood — Waukee, Iowa, United States (enrolling)
- Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States (enrolling)
- The University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- Dana Farber Cancer Institute Longwood Medical Center — Boston, Massachusetts, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- The Cancer and Hematology Centers — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- Hattiesburg Hematology and Oncology Clinic — Hattiesburg, Mississippi, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Nebraska Cancer Specialists St Francis Grand Island — Grand Island, Nebraska, United States (enrolling)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- The Valley Hospital, Inc — Paramus, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States (enrolling)
- Atrium Health Levine Cancer Institute (Lci) — Charlotte, North Carolina, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
- University of Alabama At Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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