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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)
NCT06742996 · BeOne Medicines
In plain English
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Official title
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-03-05
Estimated completion: 2032-03-30
Last updated: 2026-03-19
Interventions
Drug: SonrotoclaxDrug: ZanubrutinibDrug: Placebo
Primary outcomes
- • Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) (Approximately 41 months)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1.877.828.5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (149)
University of Alabama At Birmingham HospitalRecruiting
Birmingham, Alabama, United States
Mayo Clinic PhoenixRecruiting
Phoenix, Arizona, United States
Yale University, Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Memorial Cancer Institute, Memorial Healthcare SystemRecruiting
Pembroke Pines, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
Fort Wayne Medical Oncology and HematologyRecruiting
Fort Wayne, Indiana, United States
Mission Cancer and BloodRecruiting
Waukee, Iowa, United States
University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer Institute Longwood Medical CenterRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
The Cancer and Hematology CentersRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Hattiesburg Hematology and Oncology ClinicRecruiting
Hattiesburg, Mississippi, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Nebraska Cancer Specialists St Francis Grand IslandRecruiting
Grand Island, Nebraska, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
The Valley Hospital, IncRecruiting
Paramus, New Jersey, United States
Atrium Health Levine Cancer Institute (Lci)Recruiting
Charlotte, North Carolina, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Atrium Health Wake Forest BaptistRecruiting
Winston-Salem, North Carolina, United States
University HospitalsRecruiting
Cleveland, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Ohio Health Research InstituteRecruiting
Columbus, Ohio, United States
Penn State Milton S Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
McGlinn Cancer InstituteRecruiting
West Reading, Pennsylvania, United States
Tennesse Oncology Chattanooga DowntownRecruiting
Chattanooga, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Oncology Austin MidtownRecruiting
Round Rock, Texas, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virgina Cancer SpecialistsRecruiting
Gainesville, Virginia, United States
Vcu Massey Cancer CenterRecruiting
Richmond, Virginia, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)Recruiting
Vancouver, Washington, United States
Hospital AlemanRecruiting
CABA, Argentina
FUNDALEURecruiting
Caba, Argentina
Hospital Italiano de Buenos AiresRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Hospital Universitario de CordobaRecruiting
Córdoba, Argentina
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Genesiscare North ShoreRecruiting
St Leonards, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Sunshine Coast Hospital and Health ServiceRecruiting
Birtinya, Queensland, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Rockingham HospitalRecruiting
Cooloongup, Western Australia, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
One Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Perth Blood InstituteRecruiting
West Perth, Western Australia, Australia
Ordensklinikum Linz Gmbh ElisabethinenRecruiting
Linz, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus SalzburgRecruiting
Salzburg, Austria
Uk St PoeltenRecruiting
Sankt Pölten, Austria
Medical University Vienna OncologyRecruiting
Vienna, Austria
Fundacao Pio Xii Hospital de Amor de BarretosRecruiting
Barretos, Brazil
Hospital Felicio RochoRecruiting
Belo Horizonte, Brazil
Universidade de Campinas Centro de Hematologia E HemoterapiaRecruiting
Campinas, Brazil
Hospital Erasto GaertnerRecruiting
Curitiba, Brazil
Instituto Joinvilense de Hematologia E OncologiaRecruiting
Joinville, Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em SaudeRecruiting
Petrópolis, Brazil
Hospital de Clinicas de Porto AlegreRecruiting
Porto AlegreRS, Brazil
Hospital Do Cancer de PernambucoRecruiting
Recife, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia CelularRecruiting
São Paulo, Brazil
Hospital Santa Rita de Cassia AfeccRecruiting
Vitória, Brazil
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Beijing HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, Fujian, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Jiangsu Province HospitalRecruiting
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Xuzhou, Jiangsu, China
Jiangxi Province Cancer HospitalRecruiting
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and InstituteRecruiting
Shenyang, Liaoning, China
Shaanxi Provincial Peoples HospitalRecruiting
Xi'an, Shaanxi, China
Linyi Cancer HospitalRecruiting
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University Branch West CoastRecruiting
Qingdao, Shandong, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalRecruiting
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of MedicinechengzhanRecruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, Zhejiang, China
Chu Montpellier Hopital Saint EloiRecruiting
Montpellier, France
Centre Hospitalier Universitaire Nantes Hotel DieuRecruiting
Nantes, France
Chu Hopital Lyon SudRecruiting
PierreBenite, France
Chu Tours Hopital BretonneauRecruiting
Tours, France
Klinikum Chemnitz GgmbhRecruiting
Chemnitz, Germany
Klinikum Der Johann Wolfgang Goethe UniversitatRecruiting
Frankfurt am Main, Germany
Universitatsklinikum HalleRecruiting
Halle, Germany
Universitatsklinikum Hamburg EppendorfRecruiting
Hamburg, Germany
Stauferklinikum Schwabisch Gmund Kliniken OstalbRecruiting
Mutlangen, Germany
Dept of Medicine Iii, University HospitallmuRecruiting
München, Germany
Policlinico Sorsola Malpighi, Aou Di BolognaRecruiting
Bologna, Italy
Ospedale Vito Fazzi, Asl LecceRecruiting
Leece, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IrstRecruiting
Meldola, Italy
Azienda Sanitaria Universitaria Giuliano IsontinaRecruiting
Trieste, Italy
Centroricerche Cliniche Di Verona SrlRecruiting
Verona, Italy
Aichi Cancer Center Hospital Clinical OncologyRecruiting
Nagoya, Aichi-ken, Japan
Toyohashi Municipal HospitalRecruiting
Toyohashishi, Aichi-ken, Japan
Chiba Cancer CenterRecruiting
Chiba, Chiba, Japan
Matsuyama Red Cross HospitalRecruiting
Matsuyama, Ehime, Japan
Ogaki Municipal HospitalRecruiting
Ōgaki, Gifu, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalRecruiting
Hiroshima, Hiroshima, Japan
Hokkaido University HospitalRecruiting
Sapporo, Hokkaido, Japan
Kobe City Medical Center General HospitalRecruiting
KobeShi, Hyōgo, Japan
Kagoshima University HospitalRecruiting
Kagoshima, Kagoshima-ken, Japan
Kanagawa Cancer CenterRecruiting
Yokohama, Kanagawa, Japan
Tohoku University HospitalRecruiting
Sendai, Miyagi, Japan
Kurashiki Central HospitalRecruiting
Kurashikishi, Okayama-ken, Japan
Osaka Red Cross HospitalRecruiting
Osakashi, Osaka, Japan
Dokkyo Medical University Saitama Medical CenterRecruiting
Koshigaya, Saitama, Japan
Institute of Science Tokyo HospitalRecruiting
Bunkyoku, Tokyo, Japan
National Hospital Organization Okayama Medical CenterRecruiting
Okayama, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Yokohama Municipal Citizens HospitalRecruiting
Yokohama, Japan
North Shore HospitalRecruiting
Auckland, New Zealand
Christchurch HospitalRecruiting
Christchurch, New Zealand
Dunedin HospitalRecruiting
Dunedin, New Zealand
Tauranga HospitalRecruiting
Tauranga, New Zealand
Wellington Regional Hospital (Ccdhb)Recruiting
Wellington, New Zealand
Pratia McM KrakowRecruiting
Krakow, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W LodziRecruiting
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W LublinieRecruiting
Lublin, Poland
Aidport Sp Z O ORecruiting
Skorzewo, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii I HematologiiRecruiting
Wroclaw, Poland
Auxilio Mutuo Cancer CenterRecruiting
San Juan, Puerto Rico
Pusan National University HospitalRecruiting
Seogu, Busan Gwang'yeogsi, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical CenterRecruiting
SongpaGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Yeouido St Marys HospitalRecruiting
Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Ico H Duran I ReynalsRecruiting
Barcelona, Spain
Hospital Universitario Fundacion Jimenez DiazRecruiting
Madrid, Spain
H Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Etlik City HospitalRecruiting
Ankara, Turkey (Türkiye)
Antalya Memorial HospitalRecruiting
Dokuma, Turkey (Türkiye)
Kocaeli Universitesi Tip FakultesiRecruiting
Kocaeli, Turkey (Türkiye)
The Royal Bournemouth and Christchurch Hospitals Nhs FoundationRecruiting
Bournemouth, United Kingdom
Beatson West of Scotland Cancer CentreRecruiting
Glasgow, United Kingdom
Oxford University Hospitals Nhs Trust Churchill HospitalRecruiting
Headington, United Kingdom
University College HospitalRecruiting
London, United Kingdom
Clatterbridge Cancer CentreRecruiting
Metropolitan Borough of Wirral, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom