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A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Sponsor: BeiGene
Summary
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.
Official title: An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2017-10-31
Completion Date
2027-10-31
Last Updated
2026-03-09
Healthy Volunteers
No
Interventions
Zanubrutinib
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Bendamustine
Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.
Rituximab
Administered intravenously (IV) at a dose of 375 mg/m\^2 on day 0 of cycle 1, and at a dose of 500 mg/m\^2 on day 1 of cycles 2 to 6
Venetoclax
400 mg tablets administered orally once daily.
Locations (158)
Augusta University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Florham Park, New Jersey, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Va Puget Sound Health Care System
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
The Tweed Valley Hospital
Cudgen, 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
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, 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
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, Austria
Allgemeines Krankenhaus Der Stadt Linz
Linz, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, Austria
Klinikum Wels Grieskirchen
Wels, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
Liège, Belgium
Clinique Saint Pierre
Ottignies, Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir, Belgium
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing 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
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, 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
Fakultni Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Centre Hospitalier Victor Dupouy Dargenteuil
Argenteuil, France
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Chu Caen Normandie
Caen, France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, France
Centre Hospitalier Le Mans
Le Mans, France
Centre Hospitalier Universitaire Limoges Chu de Limoges
Limoges, France
Institut Paoli Calmettes
Marseille, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France
Hopital de La Pitie Salpetriere
Paris, France
Groupe Hospitalier Du Haut Leveque
Pessac, France
Chu Hopital Lyon Sud
PierreBenite, France
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
Poitiers, France
Hopital Robert Debre
Reims, France
Hopital Pontchaillou
Rennes, France
Centre Henri Becquerel
Rouen, France
Chu Tours Hopital Bretonneau Service Pneumologie
Tours, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, France
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, Italy
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna, Italy
Universita Degli Studi La Sapienza
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Azienda Ospedaliera S Maria Di Terni
Terni, Italy
Ao Citta Della Salute E Della Scienza Di Torino Presidio O
Torino, Italy
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
North Shore Hospital
Takapuna, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk, Poland
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, Poland
Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach
Gliwice, Poland
Malopolskie Centrum Medyczne Sc
Krakow, Poland
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, Poland
Kaluga Regional Hospital
Kaluga, Kaluga Oblast, Russia
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, Russia
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, Russia
Russian Academy of Advanced Medical Studies, City Clinical Hospital
Moscow, Moscow, Russia
Nizhniy Novgorod Regional Clinical Hospital Nasemashko
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
State Budgetary Healthcare Institution Regional Clinical Dispensary
Penza, Penza Oblast, Russia
State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment
Perm, Permskiy Kray, Russia
Kemerovo Regional Clinical Hospital Na Sv Belyaev
Kemerovo, Pskov Oblast, Russia
Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, Russia
Fgu Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Clinical Hospital
Yekaterinburg, Sverdlovsk Oblast, Russia
Central City Hospital
Yekaterinburg, Sverdlovsk Oblast, Russia
Clinical Oncology Dispensary
Kazan, Tambov Oblast, Russia
Tula Area Clinical Hospital
Tula, Tula Oblast, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, Russia
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital Del Mar
Barcelona, Spain
Institut Catala Doncologia
Barcelona, Spain
Hospital de La Princesa
Madrid, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Clinica Universidad de Navarra Pamplona
Pamplona, Spain
Hospital Universitari I Politecnic La Fe
Valencia, Spain
Hospital de Dia Quironsalud Zaragoza
Zaragoza, Spain
Medicinkliniken
Borås, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Skanes Universitetssjukhus I Lund
Lund, Sweden
Universitetssjukhuset Orebro
Örebro, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Uppsala Akademiska Sjukhus
Uppsala, Sweden
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
National Taiwan University Hospital East Campus
Taipei, Taiwan
Birmingham Heartlands Hospital
Birmingham, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
The Christie Hospital
Greater Manchester, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
Barts and the London Nhs Trust
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Sarah Cannon Research Institute Uk
London, United Kingdom
Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital
Maidstone, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
The Royal Wolverhampton Nhs Trust
Wolverhampton, United Kingdom