Tests sonrotoclax with zanubrutinib for returning mantle cell lymphoma
Compares sonrotoclax plus zanubrutinib with placebo plus zanubrutinib in adults with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Ann Arbor, Baltimore, Baton Rouge, Birmingham, Boston, Charlotte, Charlottesville, Chicago, Cleveland, Columbus, Durham, Fort Wayne, Fresno, Gainesville, Grand Island, Grand Rapids, Hattiesburg, Hershey, Houston, Irvine, Madison, Nashville, New Haven, New York, Omaha, Paramus, Pembroke Pines, Richmond, Rochester, Round Rock, St Louis, Tucson, Vancouver, Waukee, West Reading, Weston, and Winston-Salem, United StatesSee the 41 sites
- Phase
- Phase 3
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- The University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United StatesTaking people
- Our Lady of the Lake HospitalBaton Rouge, United StatesTaking people
- University of Alabama At Birmingham HospitalBirmingham, United StatesTaking people
- Dana Farber Cancer Institute Longwood Medical CenterBoston, United StatesTaking people
- Atrium Health Levine Cancer Institute (Lci)Charlotte, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- University HospitalsCleveland, United StatesTaking people
- Ohio Health Research InstituteColumbus, United StatesTaking people
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesTaking people
- Ucsf FresnoFresno, United StatesTaking people
- Virgina Cancer SpecialistsGainesville, United StatesTaking people
- Nebraska Cancer Specialists St Francis - Grand IslandGrand Island, United StatesTaking people
- The Cancer and Hematology CentersGrand Rapids, United StatesTaking people
- Hattiesburg Hematology and Oncology ClinicHattiesburg, United StatesTaking people
- Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Kaiser Permanente Southern CaliforniaIrvine, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- Tennessee OncologyNashville, United StatesTaking people
- Tennessee Oncology - Nashville St. Thomas Midtown ClinicNashville, United StatesTaking people
- Yale University, Yale Cancer CenterNew Haven, United StatesTaking people
- Memorial Sloan Kettering Cancer Center MskccNew York, United StatesTaking people
- Nebraska Cancer SpecialistsOmaha, United StatesTaking people
- The Valley Hospital, Inc.Paramus, United StatesTaking people
- Memorial Cancer Institute, Memorial Healthcare SystemPembroke Pines, United StatesTaking people
- VCU Massey Cancer CenterRichmond, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- Texas Oncology Austin MidtownRound Rock, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- University of Arizona Cancer CenterTucson, United StatesTaking people
- Northwest Cancer Specialist, Pc(Us Oncology Research)Vancouver, United StatesTaking people
- Mission Cancer and BloodWaukee, United StatesTaking people
- McGlinn Cancer InstituteWest Reading, United StatesTaking people
- Cleveland Clinic FloridaWeston, United StatesTaking people
- Atrium Health Wake Forest BaptistWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT06742996EU 2024-515593-27-00
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
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.
Inclusion: 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.
Exclusion: 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; History of stroke or intracranial hemorrhage within 6 months before first dose of study drug; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Clinically significant cardiovascular disease; Known central nervous system involvement by lymphoma.