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)
Who is this study for? Adult patients with CD20-Positive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
What treatments are being studied? Zanubrutinib
Status: Active_not_recruiting
Location: See all (154) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
• Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
• Measurable disease by imaging
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Life expectancy ≥ 6 months
• Adequate bone marrow function
• Adequate renal and hepatic function
Locations
United States
Georgia
Augusta University
Augusta
Illinois
Northwestern University
Chicago
Massachusetts
Dana Farber Cancer Institute
Boston
Missouri
Research Medical Center
Kansas City
Washington University
Saint Louis
North Carolina
Duke University
Durham
New Jersey
Summit Medical Group
Florham Park
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Columbia University Medical Center
New York
Icahn School of Medicine At Mount Sinai
New York
University of Rochester
Rochester
Oregon
Oregon Health and Science University
Portland
South Dakota
Prairie Lakes Healthcare System
Watertown
Tennessee
Tennessee Oncology, Pllc Nashville
Nashville
Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock
Virginia
University of Virginia
Charlottesville
Washington
Fred Hutchinson Cancer Research Center
Seattle
Va Puget Sound Health Care System
Seattle
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Icon Cancer Centre Wesley
Auchenflower
Box Hill Hospital
Box Hill
Princess Alexandra Hospital
Brisbane
Monash Health
Clayton
Concord Repatriation General Hospital
Concord
The Tweed Valley Hospital
Cudgen
St Vincents Hospital Melbourne
Fitzroy
Peninsula Private Hospital
Frankston
Royal Brisbane and Womens Hospital
Herston
Royal Hobart Hospital
Hobart
Peter Maccallum Cancer Centre
Melbourne
Royal Perth Hospital
Perth
Calvary Mater Newcastle
Waratah
Westmead Hospital
Westmead
The Queen Elizabeth Hospital
Woodville South
Austria
Medizinische Universitatsklinik Innsbruck
Innsbruck
Allgemeines Krankenhaus Der Stadt Linz
Linz
Krankenhaus Der Barmherzigen Schwestern Linz
Linz
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg
Klinikum Wels Grieskirchen
Wels
Belgium
Universitair Ziekenhuis Brussel
Brussels
Universitair Ziekenhuis Gent
Gent
Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
Liege
Clinique Saint Pierre
Ottignies
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir
China
Beijing Friendship Hospital, Capital Medical University
Beijing
Peking Union Medical College Hospital
Beijing
Peking University Third Hospital
Beijing
The First Hospital of Jilin University
Changchun
West China Hospital, Sichuan University
Chengdu
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing
Fujian Medical University Union Hospital
Fuzhou
Guangdong Provincial Peoples Hospital
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Anhui Provincial Hospital
Hefei
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang
Jiangsu Province Hospital
Nanjing
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou
Institute of Hematology and Hospital of Blood Disease
Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Wuxi Peoples Hospital
Wuxi
Henan Cancer Hospital
Zhengzhou
France
Centre Hospitalier Victor Dupouy Dargenteuil
Argenteuil Cedex
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Chu Caen Normandie
Caen Cedex
Centre Hospitalier Departemental de Vendee
La Roche Sur Yon
Centre Hospitalier Le Mans
Le Mans
Centre Hospitalier Universitaire Limoges Chu de Limoges
Limoges Cedex
Institut Paoli Calmettes
Marseille
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes Cedex
Hopital de La Pitie Salpetriere
Paris
Groupe Hospitalier Du Haut Leveque
Pessac Cedex
Chu Hopital Lyon Sud
Pierrebenite
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
Poitiers
Hopital Robert Debre
Reims Cedex
Hopital Pontchaillou
Rennes Cedex
Centre Henri Becquerel
Rouen Cedex
Chu Tours Hopital Bretonneau Service Pneumologie
Tours
Chu Nancy Hopital Brabois
Vandoeuvrelesnancy
Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milano
Ospedale San Raffaele
Milano
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Universita Degli Studi La Sapienza
Roma
Azienda Ospedaliera S Maria Di Terni
Terni
Ao Citta Della Salute E Della Scienza Di Torino Presidio O
Torino
New Zealand
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch
Palmerston North Hospital
Palmerston North
North Shore Hospital
Takapuna
Tauranga Hospital
Tauranga
Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia
Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach
Gliwice
Malopolskie Centrum Medyczne Sc
Krakow
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz
Centrum Onkologii Ziemi Lubelskiej
Lublin
Russian Federation
Sverdlovsk Regional Clinical Hospital
Ekaterinburg
Kaluga Regional Hospital
Kaluga
Clinical Oncology Dispensary
Kazan
Kemerovo Regional Clinical Hospital Na Sv Belyaev
Kemerovo
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow
Russian Academy of Advanced Medical Studies, City Clinical Hospital
Moscow
Nizhniy Novgorod Regional Clinical Hospital Nasemashko
Nizhniy Novgorod
State Budgetary Healthcare Institution Regional Clinical Dispensary
Penza
State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment
Perm
Ryazan Regional Clinical Hospital
Ryazan
Fgu Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi
Tula Area Clinical Hospital
Tula
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd
Central City Hospital
Yekaterinburg
Spain
Hospital Universitari Germans Trias I Pujol
Badalona
Hospital Del Mar
Barcelona
Institut Catala Doncologia
Barcelona
Clinica Universidad de Navarra
Madrid
Hospital de La Princesa
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Clinica Universidad de Navarra Pamplona
Pamplona
Hospital Universitari I Politecnic La Fe
Valencia
Hospital de Dia Quironsalud Zaragoza
Zaragoza
Sweden
Medicinkliniken
Boras
Sahlgrenska Universitetssjukhuset
Goteborg
Skanes Universitetssjukhus I Lund
Lund
Universitetssjukhuset Orebro
Orebro
Karolinska Universitetssjukhuset Solna
Stockholm
Uppsala Akademiska Sjukhus
Uppsala
Taiwan
Hualien Tzu Chi Hospital
Hualien
Taipei Medical University Shuang Ho Hospital
New Taipei City
National Taiwan University Hospital East Campus
Taipei
United Kingdom
Birmingham Heartlands Hospital
Birmingham
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth
Cambridge University Hospitals Nhs Foundation Trust
Cambridge
Kent and Canterbury Hospital
Canterbury
The Christie Hospital
Greater Manchester
The Leeds Teaching Hospitals Nhs Trust
Leeds
Barts and the London Nhs Trust
London
Royal Marsden Hospital
London
Sarah Cannon Research Institute Uk
London
Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital
Maidstone
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich
Nottingham University Hospitals Nhs Trust
Nottingham
Derriford Hospital
Plymouth
Southampton General Hospital
Southampton
Sunderland Royal Hospital
Sunderland
The Royal Wolverhampton Nhs Trust
Wolverhampton
Time Frame
Start Date: 2017-10-31
Completion Date: 2026-09
Participants
Target number of participants: 590
Treatments
Experimental: Cohort 1: Bendamustine + Rituximab
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)
Experimental: Cohort 1: Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)
Experimental: Cohort 1a (China only): Bendamustine + Rituximab
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)
Experimental: Cohort 1a (China only): Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)
Experimental: Cohort 2: Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)
Experimental: Cohort 3: Venetoclax + Zanubrutinib
Approximately 110 participants, 50 without del17p and 60 with del\[17p\] or TP53 mutation will receive zanubrutinib plus venetoclax; Participants will also receive zanubrutinib starting on Cycle 1 Day 1 then daily for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Participants will receive venetoclax starting Cycle 4 Day 1 according to a 5-week dose-up schedule then daily until unacceptable toxicity, disease progression, or for a maximum of 24 cycles. Each cycle is 28 days. (Arm D)
Authors
Hanlon Sia, Craig Portell, Jonah Shulman, Bipinkumar Amin, Ian Flinn, Andrew Zelenetz, Alexey Danilov, Bruce Cheson, Paul Barr, Wojciech Janowski, Nicole Lamanna, Locke Bryan, Mazyar Shadman, Brad Kahl, Charles Farber, Robert Marcus, Solomon Graf, Muhammad-Ali Zaydan, Edwin Kingsley, Suman Kambhampati, Donald Quick, Véronique Leblond, Alain Delmer, Fontanet Bijou, Thérése Aurran-Schleinitz, Helen McCarthy, Fritz Offner, Cécile Tomowiak, Sophie De Guibert, Pierre Feugier, Dean Smith, Emmanuelle Ferrant, Marc Andre, Claire Hutchinson, Philippe Genet, Bruno Villemagne, Adrian Tempescul, George Follows, Kamel Laribi, Clemens Schmitt, Stephane Lepretre, Nimish Shah, John Gribben, Scott Marshall, Béatrice Mahé, Caroline Dartigeas, Christopher Flowers, Danielle Brander, Sonja Burgstaller, Agostino Cortelezzi, Michael Steurer, Jadwiga Hołojda, Roberto Foà, Alexander Pristupa, Tatyana Konstantinova, Ching-Yuan Kuo, Marco Gobbi, Wanda Knopińska-Posłuszny, Sergey Semochkin, Michael Fridrik, Andrzej Pluta, Jean-Pierre Vilque, Birgitta Lauri, Nicola Cascavilla, Peter Ganly, Peter Browett, Sonja Heibl, Hanna Ciepłuch, Gianluigi Reda, Emma Verner, Uwe Hahn, Javier Loscertales, Catharina Lewerin, Stephen Opat, Anders Osterborg, Adolfo De La Fuente, Martin Šimkovič, Bertil Uggla, Michael Leahy, Chieh-Lung Cheng, Kamil Kaplanov, Giuseppe Rossi, Tomáš Papajik, Marina Motta, Stephen Ting, Gunnar Juliusson, Anna Marina Liberati, Roberto Marasca, Rosemary Harrup, Sebastian Giebel, Anne-Sophie Michallet, Per-Ola Andersson, Sheng-Yen Hsiao, Krzysztof Giannopoulos, Francisco Javier López-Jiménez, Marie-Sarah Dilhuydy, Lukáš Smolej, Francesco Forconi, Alessandra Tedeschi, Eva María González-Barca, Paolo Ghia, Wojciech Jurczak, Sebastian Grosicki, Luca Laurenti, Wei-Han Huang, Richard Greil, Monica Tani, Marek Trnĕný, Tadeusz Robak, Roberto Lemoli, Shankara Paneesha, Marta Coscia, Pau Abrisqueta, Paula Marlton, Constantine Tam, Nicholas Weber, Jiří Mayer, Adrian Bloor, Sunil Iyengar, Peter Hillmen, Andreas Petzer, Dariusz Woszczyk, Dominik Wolf, Sergey Voloshin, Roman Hájek, Tomas Kozak
Related Therapeutic Areas
Sponsors
Leads: BeiGene