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New hope for tough lymphoma: Two-Drug combo tested in phase 3 trial

NCT ID NCT06742996

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This study tests whether adding sonrotoclax to the standard drug zanubrutinib helps adults with mantle cell lymphoma that has returned or stopped responding to prior therapy. About 300 participants will receive either the combination or a placebo plus zanubrutinib. The main goal is to see if the combination delays cancer progression or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell lymphoma Mantle cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    106 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Cancer Center Hospital Clinical Oncology

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Aidport Sp Z O O

    ACTIVE_NOT_RECRUITING

    Skorzewo, 60-185, Poland

  • Antalya Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Dokuma, 07025, Turkey (Türkiye)

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Atrium Health Levine Cancer Institute (Lci)

    RECRUITING

    Charlotte, North Carolina, 28204-2990, United States

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Auxilio Mutuo Cancer Center

    RECRUITING

    San Juan, 00917, Puerto Rico

  • Azienda Sanitaria Universitaria Giuliano Isontina

    ACTIVE_NOT_RECRUITING

    Trieste, 34129, Italy

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Box Hill Hospital

    ACTIVE_NOT_RECRUITING

    Box Hill, Victoria, VIC 3128, Australia

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    ACTIVE_NOT_RECRUITING

    Nantes, 44000, France

  • Centroricerche Cliniche Di Verona Srl

    ACTIVE_NOT_RECRUITING

    Verona, 37134, Italy

  • Chiba Cancer Center

    RECRUITING

    Chiba, Chiba, 260-8717, Japan

  • Christchurch Hospital

    ACTIVE_NOT_RECRUITING

    Christchurch, 8011, New Zealand

  • Chu Hopital Lyon Sud

    ACTIVE_NOT_RECRUITING

    PierreBenite, 69495, France

  • Chu Montpellier Hopital Saint Eloi

    RECRUITING

    Montpellier, 34090, France

  • Chu Tours Hopital Bretonneau

    RECRUITING

    Tours, 37000, France

  • Clatterbridge Cancer Centre

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331-3609, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195-0001, United States

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, NSW 2139, Australia

  • Dana Farber Cancer Institute Longwood Medical Center

    RECRUITING

    Boston, Massachusetts, 02215-5418, United States

  • Dept of Medicine Iii, University Hospitallmu

    RECRUITING

    München, 81377, Germany

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Diakonie Klinikum Jung Stilling Krankenhaus

    RECRUITING

    Siegen, 57074, Germany

  • Dokkyo Medical University Saitama Medical Center

    RECRUITING

    Koshigaya, Saitama, 503-8502, Japan

  • Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii

    ACTIVE_NOT_RECRUITING

    Wroclaw, 53-439, Poland

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Dunedin Hospital

    ACTIVE_NOT_RECRUITING

    Dunedin, 9016, New Zealand

  • Etlik City Hospital

    ACTIVE_NOT_RECRUITING

    Ankara, 06170, Turkey (Türkiye)

  • FUNDALEU

    ACTIVE_NOT_RECRUITING

    Caba, CP1114, Argentina

  • Fort Wayne Medical Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Fundacao Pio Xii Hospital de Amor de Barretos

    ACTIVE_NOT_RECRUITING

    Barretos, 14.784-400, Brazil

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

    ACTIVE_NOT_RECRUITING

    Petrópolis, 95070-560, Brazil

  • Genesiscare North Shore

    RECRUITING

    St Leonards, New South Wales, NSW 2065, Australia

  • H Puerta de Hierro Majadahonda

    ACTIVE_NOT_RECRUITING

    Majadahonda, 28222, Spain

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Hattiesburg Hematology and Oncology Clinic

    RECRUITING

    Hattiesburg, Mississippi, 39401-7233, United States

  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

    ACTIVE_NOT_RECRUITING

    São Paulo, 05402-000, Brazil

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    RECRUITING

    Hiroshima, Hiroshima, 730-8619, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Aleman

    RECRUITING

    Caba, 1425, Argentina

  • Hospital Clinic de Barcelona

    ACTIVE_NOT_RECRUITING

    Barcelona, 08036, Spain

  • Hospital Do Cancer de Pernambuco

    ACTIVE_NOT_RECRUITING

    Recife, 50040-000, Brazil

  • Hospital Erasto Gaertner

    ACTIVE_NOT_RECRUITING

    Curitiba, 81520-060, Brazil

  • Hospital Felicio Rocho

    ACTIVE_NOT_RECRUITING

    Belo Horizonte, 30110-068, Brazil

  • Hospital Italiano de Buenos Aires

    ACTIVE_NOT_RECRUITING

    Ciudad Autonoma Buenos Aires, 1413, Argentina

  • Hospital Santa Rita de Cassia Afecc

    RECRUITING

    Vitória, 29043-260, Brazil

  • Hospital Universitario Fundacion Jimenez Diaz

    ACTIVE_NOT_RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario de Cordoba

    ACTIVE_NOT_RECRUITING

    Córdoba, X5000HUA, Argentina

  • Hospital de Clinicas de Porto Alegre

    ACTIVE_NOT_RECRUITING

    Porto AlegreRS, 900350-903, Brazil

  • Ico H Duran I Reynals

    ACTIVE_NOT_RECRUITING

    Barcelona, 08907, Spain

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyoku, Tokyo, 113-8519, Japan

  • Instituto Joinvilense de Hematologia E Oncologia

    ACTIVE_NOT_RECRUITING

    Joinville, 89201-260, Brazil

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    ACTIVE_NOT_RECRUITING

    Meldola, 47014, Italy

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Kagoshima University Hospital

    RECRUITING

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Kaiser Permanente Southern California

    RECRUITING

    Irvine, California, 92618-3734, United States

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Klinikum Chemnitz Ggmbh

    RECRUITING

    Chemnitz, 09116, Germany

  • Kobe City Medical Center General Hospital

    RECRUITING

    KobeShi, Hyōgo, 650-0047, Japan

  • Kocaeli Universitesi Tip Fakultesi

    ACTIVE_NOT_RECRUITING

    Kocaeli, 41380, Turkey (Türkiye)

  • Kurashiki Central Hospital

    RECRUITING

    Kurashikishi, Okayama-ken, 710-8602, Japan

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276001, China

  • Matsuyama Red Cross Hospital

    RECRUITING

    Matsuyama, Ehime, 790 8524, Japan

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • McGlinn Cancer Institute

    RECRUITING

    West Reading, Pennsylvania, 19611-2143, United States

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3907, United States

  • Medical University Vienna Oncology

    ACTIVE_NOT_RECRUITING

    Vienna, 1090, Austria

  • Memorial Cancer Institute, Memorial Healthcare System

    RECRUITING

    Pembroke Pines, Florida, 33026-4119, United States

  • Memorial Sloan Kettering Cancer Center Mskcc

    RECRUITING

    New York, New York, 10065-6800, United States

  • Mission Cancer and Blood

    RECRUITING

    Waukee, Iowa, 50263, United States

  • Monash Health

    ACTIVE_NOT_RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • National Hospital Organization Okayama Medical Center

    RECRUITING

    Okayama, Okayama-ken, 701-1192, Japan

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130-2042, United States

  • Nebraska Cancer Specialists St Francis Grand Island

    RECRUITING

    Grand Island, Nebraska, 68803, United States

  • North Shore Hospital

    ACTIVE_NOT_RECRUITING

    Auckland, 0622, New Zealand

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    RECRUITING

    Vancouver, Washington, 98684-6930, United States

  • Ogaki Municipal Hospital

    RECRUITING

    Ōgaki, Gifu, 503-8502, Japan

  • Ohio Health Research Institute

    RECRUITING

    Columbus, Ohio, 43214-3907, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210-1280, United States

  • One Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Ordensklinikum Linz Gmbh Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, Osaka, 545-8586, Japan

  • Osaka Red Cross Hospital

    RECRUITING

    Osakashi, Osaka, 543-8555, Japan

  • Ospedale Vito Fazzi, Asl Lecce

    ACTIVE_NOT_RECRUITING

    Lecce, 73100, Italy

  • Our Lady of the Lake Hospital

    RECRUITING

    Baton Rouge, Louisiana, 70808-4365, United States

  • Oxford University Hospitals Nhs Trust Churchill Hospital

    RECRUITING

    Headington, OX3 7LE, United Kingdom

  • Penn State Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Perth Blood Institute

    ACTIVE_NOT_RECRUITING

    West Perth, Western Australia, WA 6005, Australia

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    ACTIVE_NOT_RECRUITING

    Bologna, 40138, Italy

  • Pratia McM Krakow

    ACTIVE_NOT_RECRUITING

    Krakow, 30-727, Poland

  • Pusan National University Hospital

    ACTIVE_NOT_RECRUITING

    Seogu, Busan Gwang'Yeogsi, 49241, South Korea

  • Rockingham Hospital

    ACTIVE_NOT_RECRUITING

    Cooloongup, Western Australia, WA 6168, Australia

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shaanxi Provincial Peoples Hospital

    RECRUITING

    Xi'an, Shaanxi, 710068, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, Sichuan, 610071, China

  • Stauferklinikum Schwabisch Gmund Kliniken Ostalb

    RECRUITING

    Mutlangen, 73557, Germany

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Sunshine Coast Hospital and Health Service

    ACTIVE_NOT_RECRUITING

    Birtinya, Queensland, QLD 4575, Australia

  • Tauranga Hospital

    ACTIVE_NOT_RECRUITING

    Tauranga, 3112, New Zealand

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Tennessee Oncology Nashville St Thomas Midtown Clinic

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Texas Oncology Austin Midtown

    RECRUITING

    Round Rock, Texas, 78681-4019, United States

  • The Affiliated Hospital of Qingdao University Branch West Coast

    RECRUITING

    Qingdao, Shandong, 266555, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • The Cancer and Hematology Centers

    RECRUITING

    Grand Rapids, Michigan, 49503-2563, United States

  • The Catholic University of Korea, Seoul St Marys Hospital

    ACTIVE_NOT_RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The Catholic University of Korea, Yeouido St Marys Hospital

    ACTIVE_NOT_RECRUITING

    Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345, South Korea

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    RECRUITING

    Hangzhou, Zhejiang, 310002, China

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    RECRUITING

    Bournemouth, BH7 7DW, United Kingdom

  • The University of Maryland Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • The Valley Hospital, Inc

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

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

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Toyohashi Municipal Hospital

    RECRUITING

    Toyohashishi, Aichi-ken, 441-8570, Japan

  • Ucsf Fresno

    RECRUITING

    Fresno, California, 93701, United States

  • Uk St Poelten

    ACTIVE_NOT_RECRUITING

    Sankt Pölten, 3100, Austria

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universidade de Campinas Centro de Hematologia E Hemoterapia

    ACTIVE_NOT_RECRUITING

    Campinas, 13083-878, Brazil

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    RECRUITING

    Salzburg, 5020, Austria

  • Universitatsklinikum Frankfurt

    RECRUITING

    Frankfurt am Main, 60596, Germany

  • Universitatsklinikum Halle

    RECRUITING

    Halle, 06120, Germany

  • Universitatsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • University College Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospitals

    RECRUITING

    Cleveland, Ohio, 44106-1716, United States

  • University of Alabama At Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294-0004, United States

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724-0001, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637-1443, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-1382, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908-0817, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    ACTIVE_NOT_RECRUITING

    Lublin, 20-090, Poland

  • Vcu Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298-5026, United States

  • Virgina Cancer Specialists

    RECRUITING

    Gainesville, Virginia, 20155-3257, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Wellington Regional Hospital (Ccdhb)

    ACTIVE_NOT_RECRUITING

    Wellington, 6021, New Zealand

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, NSW 2145, Australia

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    ACTIVE_NOT_RECRUITING

    Lodz, 93-513, Poland

  • Yale University Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520-8028, United States

  • Yokohama Municipal Citizens Hospital

    RECRUITING

    Yokohama, 221-0855, Japan

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