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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)
Sponsor: BeOne Medicines
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-03-05
Completion Date
2032-03-30
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Placebo
Administered orally
Locations (145)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Ucsf Fresno
Fresno, California, United States
Kaiser Permanente Southern California
Irvine, California, United States
Yale University Yale Cancer Center
New Haven, Connecticut, United States
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Mission Cancer and Blood
Waukee, Iowa, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
The Valley Hospital, Inc
Paramus, New Jersey, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Tennessee Oncology Nashville St Thomas Midtown Clinic
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Texas Oncology Austin Midtown
Round Rock, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virgina Cancer Specialists
Gainesville, Virginia, United States
Vcu Massey Cancer Center
Richmond, Virginia, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Aleman
Caba, Argentina
FUNDALEU
Caba, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Hospital Universitario de Cordoba
Córdoba, Argentina
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Rockingham Hospital
Cooloongup, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Uk St Poelten
Sankt Pölten, Austria
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Hospital Felicio Rocho
Belo Horizonte, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, Brazil
Hospital Do Cancer de Pernambuco
Recife, Brazil
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Chu Montpellier Hopital Saint Eloi
Montpellier, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France
Chu Hopital Lyon Sud
PierreBenite, France
Chu Tours Hopital Bretonneau
Tours, France
Klinikum Chemnitz Ggmbh
Chemnitz, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Germany
Universitatsklinikum Halle
Halle, Germany
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, Germany
Dept of Medicine Iii, University Hospitallmu
München, Germany
Diakonie Klinikum Jung Stilling Krankenhaus
Siegen, Germany
Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
Stuttgart, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy
Ospedale Vito Fazzi, Asl Lecce
Lecce, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Centroricerche Cliniche Di Verona Srl
Verona, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashishi, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan