Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
- Registration Number
- NCT04170283
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500
Not provided
- 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)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib in combination with Tislelizumab Tislelizumab Participants to receive the combination as in the parent study (Australia Only) Zanubrutinib (BGB-3111) Zanubrutinib All participants to receive open-label zanubrutinib Zanubrutinib in combination with Tislelizumab Zanubrutinib Participants to receive the combination as in the parent study (Australia Only)
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 5 years Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to 5 years Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of death due to any reason
Progression-Free Survival (PFS) per investigator assessment Up to 5 years 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
Duration of Response (DOR) per investigator assessment Up to 5 years 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
Trial Locations
- Locations (152)
Chu Hopital Lyon Sud
🇫🇷PierreBenite, France
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
🇮🇹Pavia, Italy
Toyohashi Municipal Hospital
🇯🇵Toyohashi, Aichi, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Aiiku Hospital
🇯🇵Sapporo, Hokkaido, Japan
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
Oncology and Hematology Associates of Southwest Virginia, Inc
🇺🇸Roanoke, Virginia, United States
Florida Cancer Specialists Fort Myers
🇺🇸Fort Myers, Florida, United States
Scri Florida Cancer Specialists North
🇺🇸Saint 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
University of Washington Seattle Cancer Alliance
🇺🇸Seattle, Washington, 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
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, China
Peking University Peoples Hospital
🇨🇳Beijing, Beijing, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, 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, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Fakultni Nemocnice Brno
🇨🇿Brno, Czechia
Institute of Hematology and Hospital of Blood Disease
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Czechia
Fakultni Nemocnice Ostrava
🇨🇿Ostrava, Czechia
University Hospital Vinohrady Hematology Department
🇨🇿Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, 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
Amsterdam Umc Amc
🇳🇱Amsterdam, Netherlands
Hopital Saint Louis
🇫🇷Paris, 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
🇮🇹Milano, Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
🇮🇹Modena, Italy
Aou Maggiore Della Carita
🇮🇹Novara, 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
Inje University Busan Paik Hospital
🇰🇷Busan, Busan Gwang'yeogsi, Korea, Republic of
Dong A University Hospital
🇰🇷Busan, Busan Gwang'yeogsi, Korea, Republic of
Albert Schweitzer Ziekenhuis
🇳🇱Nijmegen, Netherlands
National Cancer Center
🇰🇷Goyangsi, Gyeonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center Hematology Oncology
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
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
🇵🇱Brzozow, Poland
Szpital Uniwersytecki Nr Im Dr Jana Biziela
🇵🇱Bydgoszcz, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
🇵🇱Chorzow, 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
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
🇹🇷Tekirdag, Turkey
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