Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
NCT ID: NCT04170283
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
955 participants
INTERVENTIONAL
2020-01-16
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanubrutinib (BGB-3111)
All participants to receive open-label zanubrutinib
Zanubrutinib
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.
Zanubrutinib in combination with Tislelizumab
Participants to receive the combination as in the parent study (Australia Only)
Zanubrutinib
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.
Tislelizumab
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..
Interventions
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Zanubrutinib
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.
Tislelizumab
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..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
Rocky Mountain Cancer Centers Centennial
Centennial, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Florida Cancer Specialists Fort Myers
Fort Myers, Florida, United States
Scri Florida Cancer Specialists North
St. Petersburg, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Forrest General Hospital Cancer Center
Hattiesburg, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Florham Park, New Jersey, United States
Atlantic Health System
Morristown, New Jersey, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke, Virginia, United States
University of Washington Seattle Cancer Alliance
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
Paratus Clinical Research Woden
Canberra, Australian Capital Territory, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Border Medical Oncology
East Albury, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Brisbane Clinic For Lymphoma
Greenslopes, Queensland, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Barwon Health the Geelong Hospital
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
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
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Fakultni Nemocnice Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
University Hospital Vinohrady Hematology Department
Prague, , Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, , France
Centre Hospitalier Le Mans
Le Mans, , France
Hopital Saint Louis
Paris, , France
Chu Hopital Lyon Sud
PierreBenite, , France
Chu Tours Hopital Bretonneau
Tours, , France
Srh Kliniken Landkreis Sigmaringen
Sigmaringen, , Germany
General Hospital of Athens Alexandra
Athens, , Greece
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, , Italy
Aou Maggiore Della Carita
Novara, , Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, , Italy
Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
Ravenna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliera S Maria Di Terni
Terni, , Italy
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino, , Italy
Aou Santa Maria Della Misericordia Di Udine
Udine, , Italy
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Amsterdam Umc Amc
Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis
Nijmegen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Aotearoa Clinical Trials
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Waikato Hospital
Hamilton Waikato, , New Zealand
North Shore Hospital
Takapuna, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, , New Zealand
Interhem Opieka Szpitalna
Bialystok, , Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, , Poland
Szpital Uniwersytecki Nr Im Dr Jana Biziela
Bydgoszcz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdask, , Poland
Malopolskie Centrum Medyczne Sc
Krakow, , Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, , Poland
Centrum Medyczne Pratia Poznan
Skorzewo Poznan, , Poland
Inje University Busan Paik Hospital
Busan, Busan Gwang'yeogsi, South Korea
Dong A University Hospital
Busan, Busan Gwang'yeogsi, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center Hematology Oncology
Seoul, Seoul Teugbyeolsi, South Korea
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Ico Hug Trias I Pujol
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Ico Girona
Girona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Skanes Universitetssjukhus I Lund
Lund, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Namik Kemal University
Tekirdağ, , Turkey (Türkiye)
Nhs Grampian Ppds
Aberdeen, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Christie Hospital
Greater Manchester, , United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
St Jamess Institute of Oncology
Leeds, , United Kingdom
Barts Health Nhs Trust
London, , United Kingdom
University College Hospital
London, , United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, , United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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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 A, Tam CS. Outcomes following transition from ibrutinib to zanubrutinib in patients with Waldenstrom macroglobulinemia from ASPEN. Blood Adv. 2025 Sep 9:bloodadvances.2024015596. doi: 10.1182/bloodadvances.2024015596. Online ahead of print.
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.
Other Identifiers
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BGB-3111-LTE1
Identifier Type: -
Identifier Source: org_study_id
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