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Cancer drug zanubrutinib tested for Long-Term safety in 955 patients

NCT ID NCT04170283

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study looks at the long-term safety of the drug zanubrutinib in people with B-cell cancers who were already in a related trial. About 955 participants will continue or start taking zanubrutinib and be monitored for side effects and how well the drug controls their cancer. The goal is to see if the drug remains safe and effective over a longer period.

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

955 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Dec 2026

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.

1. Currently participating or participated recently in a BeOne (previously BeiGene) parent study 2. Intent to continue or start zanubrutinib treatment after any of the following: 1. At time of final analysis or study closure of the eligible BeOne (previously BeiGene) parent study 2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest 3. At an alternative timepoint for an alternative reason 3. Patient who is currently on zanubrutinib treatment: Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment 4. Zanubrutinib-naive patient: Must meet the following criteria ≤ 15 days before first dose of study drug: 1. Platelets ≥ 50,000/mm3 2. Absolute neutrophil count ≥ 750/mm3 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal 4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome) 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec 6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure 7. Creatinine clearance ≥ 30 mL/min 5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control. Key Exclusion Criteria: 1. Permanently discontinued from zanubrutinib treatment in the BeOne (previously BeiGene) parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent 2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy 3. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk 4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol 5. Pregnant or lactating woman 6. Inability to comply with study procedures 7. Concurrent participation in another therapeutic clinical study 8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm

As listed by the trial registrant

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

B cell malignancies

Contacts and locations

Locations

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804, Japan

  • Albert Schweitzer Ziekenhuis

    Nijmegen, 6525 GA, Netherlands

  • Amsterdam Umc Amc

    Amsterdam, 1105 AZ, Netherlands

  • Aotearoa Clinical Trials

    Auckland, 2025, New Zealand

  • Aou Maggiore Della Carita

    Novara, 28100, Italy

  • Aou Santa Maria Della Misericordia Di Udine

    Udine, 33100, Italy

  • Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera S Maria Di Terni

    Terni, 05100, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Banner Md Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Barts Health Nhs Trust

    London, EC1A 7BE, United Kingdom

  • Barwon Health the Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Border Medical Oncology

    East Albury, New South Wales, 2640, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Brisbane Clinic For Lymphoma

    Greenslopes, Queensland, 4120, Australia

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Carti Cancer Center

    Little Rock, Arkansas, 72205, United States

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076, France

  • Centrum Medyczne Pratia Poznan

    Skorzewo Poznan, 60-185, Poland

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090, Poland

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Chu Tours Hopital Bretonneau

    Tours, 37000, France

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE, United Kingdom

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdask, 80-219, Poland

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dong A University Hospital

    Busan, Busan Gwang'yeogsi, 49201, South Korea

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

  • Fakultni Nemocnice Brno

    Brno, 62500, Czechia

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 00, Czechia

  • Flinders Medical Centre

    Bedford PK, South Australia, 5042, Australia

  • Florida Cancer Specialists Fort Myers

    Fort Myers, Florida, 33916, United States

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Forrest General Hospital Cancer Center

    Hattiesburg, Mississippi, 39401, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • General Hospital of Athens Alexandra

    Athens, 11528, Greece

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hopital Saint Louis

    Paris, 75010, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitario de Toledo

    Toledo, 45004, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Ico Girona

    Girona, 17007, Spain

  • Ico Hug Trias I Pujol

    Barcelona, 08916, Spain

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, 5037, Australia

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066, Australia

  • Inje University Busan Paik Hospital

    Busan, Busan Gwang'yeogsi, 47392, South Korea

  • Institut Catala D'Oncologia

    L'Hospitalet de Llobregat, Spain

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Interhem Opieka Szpitalna

    Bialystok, 15748, Poland

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014, Italy

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • John Flynn Private Hospital

    Tugun, Queensland, 4224, Australia

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76, Sweden

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Medical Oncology Associates

    Spokane, Washington, 99208, United States

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Namik Kemal University

    Tekirdağ, 59100, Turkey (Türkiye)

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • Nhs Grampian Ppds

    Aberdeen, AB25 2ZN, United Kingdom

  • North Shore Hospital

    Takapuna, 0622, New Zealand

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB, United Kingdom

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401, United States

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Roanoke, Virginia, 24014, United States

  • Optum Medical Care, Pc.

    Westbury, New York, 11590, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Paratus Clinical Research Woden

    Canberra, Australian Capital Territory, 2606, Australia

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Peninsula Private Hospital

    Frankston, Victoria, 3199, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL6 8DH, United Kingdom

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138, Italy

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102, Australia

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000, China

  • Rocky Mountain Cancer Centers Centennial

    Centennial, Colorado, 80112, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500, Poland

  • Samsung Medical Center Hematology Oncology

    Seoul, Seoul Teugbyeolsi, 135-740, South Korea

  • Scri Florida Cancer Specialists North

    St. Petersburg, Florida, 33705, United States

  • Scri Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • Skanes Universitetssjukhus I Lund

    Lund, 221 85, Sweden

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Srh Kliniken Landkreis Sigmaringen

    Sigmaringen, 72488, Germany

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St Jamess Institute of Oncology

    Leeds, LS9 7LP, United Kingdom

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200, Poland

  • Szpital Uniwersytecki Nr Im Dr Jana Biziela

    Bydgoszcz, 85-168, Poland

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Tauranga Hospital

    Tauranga, 3112, New Zealand

  • Tennessee Oncology

    Nashville, Tennessee, 37205, United States

  • Texas Oncology Fort Worth Cancer Center

    Fort Worth, Texas, 76104-2150, United States

  • Texas Oncology San Antonio Medical Center Usor

    San Antonio, Texas, 78240, United States

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Christie Hospital

    Greater Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW, United Kingdom

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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

    Wuhan, Hubei, 430030, China

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570, Japan

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

    Wuhan, Hubei, 430022, China

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121, Italy

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124, Italy

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University Hospital Vinohrady Hematology Department

    Prague, 10034, Czechia

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Washington Seattle Cancer Alliance

    Seattle, Washington, 98185, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000, Czechia

  • Waikato Hospital

    Hamilton Waikato, 3204, New Zealand

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021, New Zealand

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510, Poland

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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