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B-cell MalignanciesPhase 3NCT04170283

A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib

A Phase 3 study testing Zanubrutinib and Tislelizumab in people with B-cell Malignancies, run by BeOne Medicines at 153 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Malignancies
What is being tested?
Zanubrutinib and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
955 participants
Where
153 sitesin 18 countries
Study dates
16 Jan 2020to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
  • Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
  • 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
  • Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
  • Pregnant or lactating woman
  • Inability to comply with study procedures
Show all 9Show fewer
  • Concurrent participation in another therapeutic clinical study
  • History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

153 sites in 18 countries.

153 sites in 18 countries

United States26 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers Centennial

    Centennial, Colorado, 80112

  • Scri Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Duke University Hospital

    Durham, North Carolina, 27705

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Florida Cancer Specialists Fort Myers

    Fort Myers, Florida, 33916

  • Texas Oncology Fort Worth Cancer Center

    Fort Worth, Texas, 76104-2150

  • Banner Md Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Forrest General Hospital Cancer Center

    Hattiesburg, Mississippi, 39401

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Carti Cancer Center

    Little Rock, Arkansas, 72205

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • Tennessee Oncology

    Nashville, Tennessee, 37205

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Roanoke, Virginia, 24014

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Texas Oncology San Antonio Medical Center Usor

    San Antonio, Texas, 78240

  • University of Washington Seattle Cancer Alliance

    Seattle, Washington, 98185

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Scri Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Optum Medical Care, Pc.

    Westbury, New York, 11590

Other trials in United States

Australia26 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • Flinders Medical Centre

    Bedford PK, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Paratus Clinical Research Woden

    Canberra, Australian Capital Territory, 2606

  • Monash Health

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Border Medical Oncology

    East Albury, New South Wales, 2640

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Peninsula Private Hospital

    Frankston, Victoria, 3199

  • Barwon Health the Geelong Hospital

    Geelong, Victoria, 3220

  • Brisbane Clinic For Lymphoma

    Greenslopes, Queensland, 4120

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, 5037

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

China23 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

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

    Shanghai, Shanghai Municipality, 200092

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

United Kingdom13 sites

  • Nhs Grampian Ppds

    Aberdeen, AB25 2ZN

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Christie Hospital

    Greater Manchester, M20 4BX

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE

  • St Jamess Institute of Oncology

    Leeds, LS9 7LP

  • Barts Health Nhs Trust

    London, EC1A 7BE

  • University College Hospital

    London, NW1 2PG

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL6 8DH

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy10 sites

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124

  • Aou Maggiore Della Carita

    Novara, 28100

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera S Maria Di Terni

    Terni, 05100

  • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino

    Torino, 10126

  • Aou Santa Maria Della Misericordia Di Udine

    Udine, 33100

Other trials in Italy

Poland10 sites

  • Interhem Opieka Szpitalna

    Bialystok, 15748

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200

  • Szpital Uniwersytecki Nr Im Dr Jana Biziela

    Bydgoszcz, 85-168

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdask, 80-219

  • Pratia McM Krakow

    Krakow, 30-727

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Centrum Medyczne Pratia Poznan

    Skorzewo Poznan, 60-185

Other trials in Poland

Spain9 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Ico Hug Trias I Pujol

    Barcelona, 08916

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Ico Girona

    Girona, 17007

  • Institut Catala D'Oncologia

    L'Hospitalet de Llobregat

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Toledo

    Toledo, 45004

Other trials in Spain

New Zealand7 sites

  • Auckland City Hospital

    Auckland, 1023

  • Aotearoa Clinical Trials

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton Waikato, 3204

  • North Shore Hospital

    Takapuna, 0622

  • Tauranga Hospital

    Tauranga, 3112

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021

Other trials in New Zealand

Czechia6 sites

  • Fakultni Nemocnice Brno

    Brno, 62500

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 00

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000

  • University Hospital Vinohrady Hematology Department

    Prague, 10034

Other trials in Czechia

France5 sites

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • Hopital Saint Louis

    Paris, 75010

  • Chu Tours Hopital Bretonneau

    Tours, 37000

Other trials in France

South Korea5 sites

  • Inje University Busan Paik Hospital

    Busan, Busan Gwang'yeogsi, 47392

  • Dong A University Hospital

    Busan, Busan Gwang'yeogsi, 49201

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center Hematology Oncology

    Seoul, Seoul Teugbyeolsi, 135-740

Other trials in South Korea

Japan4 sites

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

Other trials in Japan

Netherlands3 sites

  • Amsterdam Umc Amc

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis

    Nijmegen, 6525 GA

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Sweden2 sites

  • Skanes Universitetssjukhus I Lund

    Lund, 221 85

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

Other trials in Sweden

Germany1 site

  • Srh Kliniken Landkreis Sigmaringen

    Sigmaringen, 72488

Other trials in Germany

Greece1 site

  • General Hospital of Athens Alexandra

    Athens, 11528

Other trials in Greece

Taiwan1 site

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

Other trials in Taiwan

Turkey (Türkiye)1 site

  • Namik Kemal University

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

About this study

Official title: An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up after treatment. Information collected in this study will help health authorities better understand the long-term effects of zanubrutinib.

Being tested
Zanubrutinib, Tislelizumab
Keywords
Zanubrutinib, Bruton's tyrosine kinase (BTK) inhibitor, long-term extension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111

    Participants will receive a total dose of 320 mg daily, given either as 160 mg BID or 320 mg QD, or the last dose level received in the sponsor parent study.

  • TislelizumabDrug

    Also called BGB-A317

    Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks.

Study groups in NCT04170283
Study groupRoleWhat they receive
Zanubrutinib (BGB-3111)ExperimentalAll participants to receive open-label zanubrutinib
Receives: Drug: Zanubrutinib
Zanubrutinib in combination with TislelizumabExperimentalParticipants to receive the combination as in the parent study (Australia Only)
Receives: Drug: Zanubrutinib; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) and according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    PFS is defined as time from start of treatment in an eligible BeOne (previously BeiGene) study to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment

    Measured: Up to 5 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the date that a confirmed response (CR or PR) was first observed in an eligible BeOne (previously BeiGene) study to the date of first documented disease progression or death, whichever occurred first, and as determined by the investigator.

    Measured: Up to 5 years

  3. Overall Survival (OS)

    OS is defined as the ime from the starting date of zanubrutinib in the eligible BeOne (previously BeiGene) study to the date of death due to any reason

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start16 Jan 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
955 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04170283
Sponsor's protocol ID
BGB-3111-LTE1
Other IDs
2020-000547-31, 2024-511267-28-00
Status last verified
Aug 2026
First submitted
18 Nov 2019
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Expanded access
Available

Publications

  • Garcia-Sanz R, Owen RG, Jurczak W, Dimopoulos MA, McCarthy H, Cull G, Opat SS, Castillo JJ, Kersten MJ, Wahlin BE, Grosicki S, Prathikanti R, Tian T, Allewelt H, Cohen AC, Tam CS. Outcomes after transition from ibrutinib to zanubrutinib in patients with Waldenstrom macroglobulinemia from the ASPEN study. Blood Adv. 2025 Dec 23;9(24):6538-6546. doi: 10.1182/bloodadvances.2024015596.

    PubMed 40924923

  • Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.

    PubMed 38502198

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zanubrutinib and Tislelizumab in people with B-cell Malignancies, run by BeOne Medicines at 153 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Australia, China, United Kingdom, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04170283, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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