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
NCT ID: NCT06742996
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-03-05
2032-10-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination.
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination.
Zanubrutinib
Administered orally
Placebo
Administered orally
Interventions
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Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
* 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Hospital Santa Rita de Cassia Afecc
Vitória, , Brazil
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Mayo Clinic Phoenix
Phoenix, Arizona, 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
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Mission Cancer and Blood
Waukee, Iowa, United States
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
Atrium Health Levine Cancer Institute (Lci)
Charlotte, 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
Tennesse Oncology Chattanooga Downtown
Chattanooga, 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
Hospital Aleman
CABA, , Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
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
Linear Clinical Research
Nedlands, Western Australia, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Ordensklinikum Linz Gmbh Elisabethinen
Linz, , Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, , Austria
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
Hospital Erasto Gaertner
Curitiba, , Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, , Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, , Brazil
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, , Brazil
Hospital Do Cancer de Pernambuco
Recife, , Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, , Brazil
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital of 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 Province 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
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, , Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Ospedale Vito Fazzi, Asl Lecce
Leece, , 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
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
KobeShi, Hyōgo, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan
Osaka Red Cross Hospital
Osakashi, Osaka, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Institute of Science Tokyo Hospital
Tokyo, , Japan
Yokohama Municipal Citizens Hospital
Yokohama, , Japan
North Shore Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, , New Zealand
Pratia McM Krakow
Krakow, , Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, , Poland
Uniwersytecki Szpital Kliniczny Nr W Lublinie
Lublin, , Poland
Aidport Sp Z O O
Skorzewo, , Poland
Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Yeouido St Marys Hospital
Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea
Ico H Duran I Reynals
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
H Puerta de Hierro Majadahonda
Majadahonda, , Spain
Antalya Memorial Hospital
Dokuma, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
University College Hospital
London, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-515593-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20250207
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-11417-302
Identifier Type: -
Identifier Source: org_study_id