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NCT06742996PHASE3Recruiting

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)

BeOne Medicines

Start Date

3/5/2025

Completion Date

3/30/2032

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.

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sonrotoclax

DRUG

Zanubrutinib

DRUG

Placebo

Interested in This Trial?

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Conditions

Mantle Cell LymphomaB Cell Lymphoma

Locations

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

United States

University of Arizona Cancer Center

Tucson, Arizona 85724-0001

United States

Ucsf Fresno

Fresno, California 93701

United States

Kaiser Permanente Southern California

Irvine, California 92618-3734

United States

Yale University Yale Cancer Center

New Haven, Connecticut 06520-8028

United States

Memorial Cancer Institute, Memorial Healthcare System

Pembroke Pines, Florida 33026-4119

United States

Cleveland Clinic Florida

Weston, Florida 33331-3609

United States

Rush University Medical Center

Chicago, Illinois 60607

United States

University of Chicago Medical Center

Chicago, Illinois 60637-1443

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46804

United States

Mission Cancer and Blood

Waukee, Iowa 50263

United States

Our Lady of the Lake Hospital

Baton Rouge, Louisiana 70808-4365

United States

The University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Dana Farber Cancer Institute Longwood Medical Center

Boston, Massachusetts 02215-5418

United States

University of Michigan

Ann Arbor, Michigan 48109-1382

United States

The Cancer and Hematology Centers

Grand Rapids, Michigan 49503-2563

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905-0001

United States

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi 39401-7233

United States

Washington University School of Medicine

St Louis, Missouri 63110-1010

United States

Nebraska Cancer Specialists St Francis Grand Island

Grand Island, Nebraska 68803

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130-2042

United States

The Valley Hospital, Inc

Paramus, New Jersey 07652

United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York 10065-6800

United States

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina 28204-2990

United States

Duke University

Durham, North Carolina 27710

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

University Hospitals

Cleveland, Ohio 44106-1716

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195-0001

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210-1280

United States

Ohio Health Research Institute

Columbus, Ohio 43214-3907

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania 17033

United States

McGlinn Cancer Institute

West Reading, Pennsylvania 19611-2143

United States

Tennessee Oncology Nashville St Thomas Midtown Clinic

Nashville, Tennessee 37205

United States

Tennessee Oncology

Nashville, Tennessee 37205

United States

Md Anderson Cancer Center

Houston, Texas 77030-3907

United States

Texas Oncology Austin Midtown

Round Rock, Texas 78681-4019

United States

University of Virginia

Charlottesville, Virginia 22908-0817

United States

Virgina Cancer Specialists

Gainesville, Virginia 20155-3257

United States

Vcu Massey Cancer Center

Richmond, Virginia 23298-5026

United States

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington 98684-6930

United States

University of Wisconsin

Madison, Wisconsin 53792-0001

United States

Hospital Aleman

CABA, 1425

Argentina

FUNDALEU

Caba, CP1114

Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, 1413

Argentina

Hospital Universitario de Cordoba

Córdoba, X5000HUA

Argentina

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

Genesiscare North Shore

St Leonards, New South Wales NSW 2065

Australia

Westmead Hospital

Westmead, New South Wales NSW 2145

Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland QLD 4575

Australia

Box Hill Hospital

Box Hill, Victoria VIC 3128

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Rockingham Hospital

Cooloongup, Western Australia WA 6168

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

One Clinical Research

Nedlands, Western Australia WA 6009

Australia

Perth Blood Institute

West Perth, Western Australia WA 6005

Australia

Ordensklinikum Linz Gmbh Elisabethinen

Linz, 4020

Austria

Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

Salzburg, 5020

Austria

Uk St Poelten

Sankt Pölten, 3100

Austria

Medical University Vienna Oncology

Vienna, 1090

Austria

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, 14.784-400

Brazil

Hospital Felicio Rocho

Belo Horizonte, 30110-068

Brazil

Universidade de Campinas Centro de Hematologia E Hemoterapia

Campinas, 13083-878

Brazil

Hospital Erasto Gaertner

Curitiba, 81520-060

Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, 89201-260

Brazil

Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

Petrópolis, 95070-560

Brazil

Hospital de Clinicas de Porto Alegre

Porto AlegreRS, 900350-903

Brazil

Hospital Do Cancer de Pernambuco

Recife, 50040-000

Brazil

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, 05402-000

Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, 29043-260

Brazil

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Beijing Hospital

Beijing, Beijing Municipality 100730

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 630014

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong 510515

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

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

Wuhan, Hubei 430022

China

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

Wuhan, Hubei 430030

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221000

China

Jiangxi Cancer Hospital

Nanchang, Jiangxi 330029

China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning 110042

China

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi 710068

China

Linyi Cancer Hospital

Linyi, Shandong 276001

China

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong 266555

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200000

China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan 610071

China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang 310002

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Chu Montpellier Hopital Saint Eloi

Montpellier, 34090

France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, 44000

France

Chu Hopital Lyon Sud

PierreBenite, 69495

France

Chu Tours Hopital Bretonneau

Tours, 37000

France

Klinikum Chemnitz Ggmbh

Chemnitz, 09116

Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, 60596

Germany

Universitatsklinikum Halle

Halle, 06120

Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, 20251

Germany

Stauferklinikum Schwabisch Gmund Kliniken Ostalb

Mutlangen, 73557

Germany

Dept of Medicine Iii, University Hospitallmu

München, 81377

Germany

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, 40138

Italy

Ospedale Vito Fazzi, Asl Lecce

Lecce, 73100

Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, 47014

Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, 34129

Italy

Centroricerche Cliniche Di Verona Srl

Verona, 37134

Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken 464-8681

Japan

Toyohashi Municipal Hospital

Toyohashishi, Aichi-ken 441-8570

Japan

Chiba Cancer Center

Chiba, Chiba 260-8717

Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime 790 8524

Japan

Ogaki Municipal Hospital

Ōgaki, Gifu 503-8502

Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima 730-8619

Japan

Hokkaido University Hospital

Sapporo, Hokkaido 060-8648

Japan

Kobe City Medical Center General Hospital

KobeShi, Hyōgo 650-0047

Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken 890-8520

Japan

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Kurashiki Central Hospital

Kurashikishi, Okayama-ken 710-8602

Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, Osaka 545-8586

Japan

Osaka Red Cross Hospital

Osakashi, Osaka 543-8555

Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama 503-8502

Japan

Institute of Science Tokyo Hospital

Bunkyoku, Tokyo 113-8519

Japan

Yokohama Municipal Citizens Hospital

Yokohama, 221-0855

Japan

North Shore Hospital

Auckland, 0622

New Zealand

Christchurch Hospital

Christchurch, 8011

New Zealand

Dunedin Hospital

Dunedin, 9016

New Zealand

Tauranga Hospital

Tauranga, 3112

New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, 6021

New Zealand

Pratia McM Krakow

Krakow, 30-727

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, 93-513

Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090

Poland

Aidport Sp Z O O

Skorzewo, 60-185

Poland

Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii

Wroclaw, 53-439

Poland

Auxilio Mutuo Cancer Center

San Juan, 00917

Puerto Rico

Pusan National University Hospital

Seogu, Busan Gwang'Yeogsi 49241

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea

The Catholic University of Korea, Yeouido St Marys Hospital

Yeongdeungpo-gu, Seoul Teugbyeolsi 07345

South Korea

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Ico H Duran I Reynals

Barcelona, 08907

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040

Spain

H Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Etlik City Hospital

Ankara, 06170

Turkey (Türkiye)

Antalya Memorial Hospital

Dokuma, 07025

Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, 41380

Turkey (Türkiye)

Birmingham Heartlands Hospital

Birmingham, B9 5SS

United Kingdom

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth, BH7 7DW

United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN

United Kingdom

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, OX3 7LE

United Kingdom

University College Hospital

London, NW1 2PG

United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom

Derriford Hospital

Plymouth, PL6 8DH

United Kingdom