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ACTIVE NOT RECRUITING
NCT03336333
PHASE3

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Sponsor: BeiGene

View on ClinicalTrials.gov

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

DRUG

Zanubrutinib

Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)

DRUG

Bendamustine

Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.

DRUG

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

DRUG

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