Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies
1 other identifier
interventional
955
17 countries
152
Brief Summary
The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2020
Longer than P75 for phase_3
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedStudy Start
First participant enrolled
January 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
October 21, 2025
October 1, 2025
7.8 years
November 18, 2019
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events (AEs)
Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
Up to 5 years
Secondary Outcomes (3)
Progression-Free Survival (PFS) per investigator assessment
Up to 5 years
Duration of Response (DOR) per investigator assessment
Up to 5 years
Overall Survival (OS)
Up to 5 years
Study Arms (2)
Zanubrutinib (BGB-3111)
EXPERIMENTALAll participants to receive open-label zanubrutinib
Zanubrutinib in combination with Tislelizumab
EXPERIMENTALParticipants to receive the combination as in the parent study (Australia Only)
Interventions
Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study.
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..
Eligibility Criteria
You may not qualify if:
- Permanently discontinued from zanubrutinib treatment in the 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
- Concurrent participation in another therapeutic clinical study
- History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (152)
Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Carti Cancer Center
Little Rock, Arkansas, 72205, United States
Rocky Mountain Cancer Centers Centennial
Centennial, Colorado, 80112, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Florida Cancer Specialists Fort Myers
Fort Myers, Florida, 33916, United States
Scri Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Forrest General Hospital Cancer Center
Hattiesburg, Mississippi, 39401, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
Clinical Research Alliance, Inc
Westbury, New York, 11590, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37205, United States
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, 76104-2150, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas, 78240, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke, Virginia, 24014, United States
University of Washington Seattle Cancer Alliance
Seattle, Washington, 98185, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
Paratus Clinical Research Woden
Canberra, Australian Capital Territory, 2606, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Border Medical Oncology
East Albury, New South Wales, 2640, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Brisbane Clinic For Lymphoma
Greenslopes, Queensland, 4120, Australia
John Flynn Private Hospital
Tugun, Queensland, 4224, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford PK, South Australia, 5042, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Health
Clayton, Victoria, 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Peninsula Private Hospital
Frankston, Victoria, 3199, Australia
Barwon Health the Geelong Hospital
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, 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
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
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
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000, Czechia
University Hospital Vinohrady Hematology Department
Prague, 10034, Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, 85925, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Hopital Saint Louis
Paris, 75010, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Chu Tours Hopital Bretonneau
Tours, 37000, France
Srh Kliniken Landkreis Sigmaringen
Sigmaringen, 72488, Germany
General Hospital of Athens Alexandra
Athens, 11528, Greece
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, 41124, Italy
Aou Maggiore Della Carita
Novara, 28100, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, 27100, Italy
Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliera S Maria Di Terni
Terni, 05100, Italy
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino, 10126, Italy
Aou Santa Maria Della Misericordia Di Udine
Udine, 33100, Italy
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Aiiku Hospital
Sapporo, Hokkaido, 064-0804, Japan
Amsterdam Umc Amc
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis
Nijmegen, 6525 GA, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
Aotearoa Clinical Trials
Auckland, 2025, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Waikato Hospital
Hamilton Waikato, 3204, New Zealand
North Shore Hospital
Takapuna, 0622, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Interhem Opieka Szpitalna
Bialystok, 15748, Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200, Poland
Szpital Uniwersytecki Nr Im Dr Jana Biziela
Bydgoszcz, 85-168, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdask, 80-219, Poland
Malopolskie Centrum Medyczne Sc
Krakow, 30-510, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510, Poland
Centrum Medyczne Pratia Poznan
Skorzewo Poznan, 60-185, Poland
Inje University Busan Paik Hospital
Busan, Busan Gwang'yeogsi, 47392, South Korea
Dong A University Hospital
Busan, Busan Gwang'yeogsi, 49201, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Samsung Medical Center Hematology Oncology
Seoul, Seoul Teugbyeolsi, 135-740, South Korea
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Ico Hug Trias I Pujol
Barcelona, 08916, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Ico Girona
Girona, 17007, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Toledo
Toledo, 45004, Spain
Skanes Universitetssjukhus I Lund
Lund, 221 85, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Namik Kemal University
Tekirdağ, 59100, Turkey (Türkiye)
Nhs Grampian Ppds
Aberdeen, AB25 2ZN, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
The Christie Hospital
Greater Manchester, M20 4BX, United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, OX3 7LE, United Kingdom
St Jamess Institute of Oncology
Leeds, LS9 7LP, United Kingdom
Barts Health Nhs Trust
London, EC1A 7BE, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, NG51PB, United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, PL6 8DH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
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.
PMID: 40924923DERIVEDMoslehi 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.
PMID: 38502198DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2019
First Posted
November 20, 2019
Study Start
January 16, 2020
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
October 21, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share