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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib (BGB-3111) | Experimental | All participants to receive open-label zanubrutinib |
|
| Zanubrutinib in combination with Tislelizumab | Experimental | Participants to receive the combination as in the parent study (Australia Only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) per investigator assessment | Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of first documentation of disease progression or death, whichever occurs first | Up to 5 years |
| Duration of Response (DOR) per investigator assessment |
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Currently participating or participated recently in a BeiGene parent study
Intent to continue or start zanubrutinib treatment after any of the following:
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
Zanubrutinib-naive patient:
Must meet the following criteria ≤ 15 days before first dose of study drug:
Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Md Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Carti Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40924923 | Derived | 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. | |
| 38502198 |
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|
| Tislelizumab | Drug | 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.. |
|
|
Time from the date that response criteria are first met after the start of zanubrutinib in the eligible BeiGene study to the date that progressive disease (PD) is objectively documented or death, whichever occurs first |
| Up to 5 years |
| Overall Survival (OS) | Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of death due to any reason | Up to 5 years |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C000707970 | tislelizumab |
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