RecruitingPhase 3NCT06742996

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)

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Sponsor

BeOne Medicines

Enrollment

300 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called CELESTIAL-RRMCL) tests whether adding a new drug called sonrotoclax to zanubrutinib (an existing targeted therapy) works better than zanubrutinib alone for people with mantle cell lymphoma that has come back or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with mantle cell lymphoma (confirmed by biopsy) - You have received 1 to 5 prior treatment regimens including a rituximab-based therapy - Your lymphoma has relapsed or is no longer responding to your last treatment - You have measurable disease on imaging - You are in reasonably good physical condition (ECOG 0–2) - Your organ function is adequate **You may NOT be eligible if...** - You have previously taken a BCL-2 inhibitor (such as venetoclax) or BTK degrader - You have previously taken a BTK inhibitor (like ibrutinib) and your disease progressed because of it - You have had a stem cell transplant or CAR-T cell therapy in the past 3–6 months - Your lymphoma has spread to the brain - You have significant heart disease or a recent stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSonrotoclax

Administered orally

DRUGZanubrutinib

Administered orally

DRUGPlacebo

Administered orally

Locations(148)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 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

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

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

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

FUNDALEU

Caba, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Hospital Universitario de Cordoba

Córdoba, 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

Medical University Vienna Oncology

Vienna, 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

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

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, 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

Klinikum Der Johann Wolfgang Goethe Universitat

Frankfurt am Main, Germany

Universitatsklinikum Halle

Halle, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Stauferklinikum Schwabisch Gmund Kliniken Ostalb

Mutlangen, Germany

Dept of Medicine Iii, University Hospitallmu

München, 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

Institute of Science Tokyo Hospital

Bunkyoku, Tokyo, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, 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 4 W Lublinie

Lublin, Poland

Aidport Sp Z O O

Skorzewo, Poland

Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii

Wroclaw, Poland

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

Seoul National University Bundang Hospital

Seongnam-si, 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

Hospital Clinic de Barcelona

Barcelona, Spain

Ico H Duran I Reynals

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

H Puerta de Hierro Majadahonda

Majadahonda, Spain

Etlik City Hospital

Ankara, Turkey (Türkiye)

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

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, United Kingdom

University College Hospital

London, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06742996

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