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

Last updated: March 20, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoproliferative Disorders

Mantle Cell Lymphoma

Lymphoma

Treatment

Zanubrutinib

Placebo

Sonrotoclax

Clinical Study ID

NCT06742996
BGB-11417-302
2024-515593-27-00
CTR20250207
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on InternationalConsensus Classification (ICC)

  • Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonalantibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment inthe 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

Exclusion Criteria:

  • Prior therapy with B-cell lymphoma-2 inhibitor

  • Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi)unless the participant was intolerant of non-zanubrutinib covalent or non-covalentBTKi

  • Prior autologous stem cell transplantation or chimeric antigen receptor T-celltherapy within 3 months before first dose of study drug

  • Prior allogeneic stem cell transplant within 6 months of the first dose of the studydrug

  • Known central nervous system involvement by lymphoma

  • Clinically significant cardiovascular disease

  • History of stroke or intracranial hemorrhage within 6 months before first dose ofstudy drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Zanubrutinib
Phase: 3
Study Start date:
February 25, 2025
Estimated Completion Date:
October 30, 2032

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • FUNDALEU

    Caba, CP1114
    Argentina

    Site Not Available

  • Hospital Aleman

    Caba, 1425
    Argentina

    Site Not Available

  • Hospital Universitario de Cordoba

    Cordoba, X5000HUA
    Argentina

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Genesiscare North Shore

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland 4575
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Rockingham Hospital

    Cooloongup, Western Australia 6168
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perth Blood Institute

    West Perth, Western Australia 6005
    Australia

    Site Not Available

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 4020
    Austria

    Site Not Available

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Uk St Poelten

    St Poelten, 3100
    Austria

    Site Not Available

  • Medical University Vienna Oncology

    Vienna, 1090
    Austria

    Site Not Available

  • Fundacao Pio Xii Hospital de Amor de Barretos

    Barretos, 14.784-400
    Brazil

    Site Not Available

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-017
    Brazil

    Site Not Available

  • Universidade de Campinas Centro de Hematologia E Hemoterapia

    Campinas, 13083-878
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, 89201-260
    Brazil

    Site Not Available

  • Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

    Petropolis, 95070-560
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903
    Brazil

    Site Not Available

  • Hospital Do Cancer de Pernambuco

    Recife, 50040000
    Brazil

    Site Not Available

  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

    Sao Paulo, 05402-000
    Brazil

    Site Not Available

  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043260
    Brazil

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 630014
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Site Not Available

  • Shaanxi Provincial Peoples Hospital

    Xian, Shaanxi 710068
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shandong 276001
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong 266555
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang 310002
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Chu Montpellier Hopital Saint Eloi

    Montpellier Cedex, 34295
    France

    Site Not Available

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes Cedex, 44093
    France

    Site Not Available

  • Chu Hopital Lyon Sud

    PierreBenite, 69495
    France

    Site Not Available

  • Chu Tours Hopital Bretonneau

    Tours, 37000
    France

    Site Not Available

  • Klinikum Chemnitz Ggmbh

    Chemnitz, 09116
    Germany

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe Universitat Medizinische Klinik I

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Universitatsklinikum Halle

    Halle, 06120
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251
    Germany

    Site Not Available

  • Dept of Medicine Iii, University Hospitallmu

    Munich, 81377
    Germany

    Site Not Available

  • Stauferklinikum Schwabisch Gmund Kliniken Ostalb

    Mutlangen, 73557
    Germany

    Site Not Available

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Ospedale Vito Fazzi, Asl Lecce

    Leece, 73100
    Italy

    Site Not Available

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34129
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126
    Italy

    Site Not Available

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi 464-8681
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi 441-8570
    Japan

    Site Not Available

  • Chiba Cancer Center

    Chibashi, Chiba 260-8717
    Japan

    Site Not Available

  • Matsuyama Red Cross Hospital

    Matsuyamashi, Ehime 790 8524
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ogaki, Gifu 503-8502
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshimashi, Hiroshima 730-8619
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshimashi, Kagoshima 890-8520
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohamashi, Kanagawa 241-8515
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendaishi, Miyagi 980-8574
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashikishi, Okayama 710-8602
    Japan

    Site Not Available

  • Osaka Red Cross Hospital

    Osakashi, Osaka 543-8555
    Japan

    Site Not Available

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama 503-8502
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Institute of Science Tokyo Hospital

    Tokyo, 113-8519
    Japan

    Site Not Available

  • Yokohama Municipal Citizens Hospital

    Yokohamashi, 221-0855
    Japan

    Site Not Available

  • Pusan National University Hospital

    Busan, Busan Gwang'yeogsi 49241
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnamsi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St Marys Hospital

    Seoul, Seoul Teugbyeolsi 07345
    Korea, Republic of

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Dunedin Hospital

    Dunedin, 9016
    New Zealand

    Site Not Available

  • North Shore Hospital

    Takapuna, 0622
    New Zealand

    Active - Recruiting

  • Tauranga Hospital

    Tauranga, 3112
    New Zealand

    Active - Recruiting

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Site Not Available

  • Aidport Sp Z O O

    Skorzewo, 60185
    Poland

    Site Not Available

  • Lower Silesian Center of Oncology, Pulmonology and Hematology

    Wroclaw, 53-439
    Poland

    Site Not Available

  • Auxilio Mutuo Cancer Center

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Ceim Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Ico H Duran I Reynals

    Barcelona, 08907
    Spain

    Site Not Available

  • H Puerta de Hierro Majadahonda

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Etlik City Hospital

    Ankara, 06170
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Antalya Memorial Hospital, 07025
    Turkey

    Site Not Available

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030
    Turkey

    Site Not Available

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Clatterbridge Cancer Centre

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Mayo Clinic Phoenix

    Phoenix, Arizona 85254
    United States

    Site Not Available

  • Yale University, Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Memorial Cancer Institute, Memorial Healthcare System

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Dana Farber Cancer Institute Longwood Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • The Valley Hospital, Inc

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • McGlinn Cancer Institute

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Oncology Austin Midtown

    Round Rock, Texas 78681
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virgina Cancer Specialists

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • Vcu Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington 98684
    United States

    Site Not Available

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