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 (174) 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
Washington, D.c.
Georgetown University Medical Center
Washington
Georgia
Emory University
Atlanta
Augusta University
Augusta
Illinois
Northwestern University
Chicago
Kentucky
Montgomery Cancer Center
Mount Sterling
Massachusetts
Dana Farber Cancer Institute
Boston
Missouri
Research Medical Center - Kansas City
Kansas City
Washington University
Saint Louis
North Carolina
Duke University Medical Center
Durham
New Jersey
Summit Medical Group, PA
Florham Park
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Columbia University Medical Center
New York
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai
New York
University of Rochester
Rochester
Oregon
Oregon Health & Science University
Portland
South Dakota
Prairie Lakes Healthcare System
Watertown
Tennessee
Tennessee Oncology - Centennial Clinic
Nashville
Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock
Texas Oncology - Tyler
Tyler
Virginia
University of Virginia
Charlottesville
Washington
Fred Hutchinson Cancer Research Center
Seattle
VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113
Seattle
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Icon Cancer Care - Wesley
Auchenflower
Monash Medical Centre
Bentleigh East
Box Hill Hospital
Box Hill
Concord Hospital
Concord
Peter MacCallum Cancer Centre
East Melbourne
Saint Vincent's Hospital Melbourne
Fitzroy
Peninsula Private Hospital
Frankston
Royal Brisbane and Women's Hospital
Herston
Royal Hobart Hospital
Hobart
Royal Perth Hospital
Perth
Icon Cancer Care - South Brisbane
South Brisbane
The Tweed Hospital
Tweed Heads
Calvary Mater Newcastle Hospital
Waratah
Westmead Hospital
Westmead
The Queen Elizabeth Hospital
Woodville South
Princess Alexandra Hospital
Woolloongabba
Austria
Medizinische Universitätsklinik Innsbruck
Innsbruck
Allgemeines Krankenhaus der Stadt Linz
Linz
Krankenhaus der Barmherzigen Schwestern Linz
Linz
Universitätsklinik für Innere Medizin Salzburg
Salzburg
Klinikum Wels-Grieskirchen
Wels
Belgium
Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph
Arlon
Universitair Ziekenhuis Brussel
Brussels
Universitair Ziekenhuis Gent
Gent
Centre Hospitalier Universitaire (CHU) de Liège - Site du Sart Tilman
Liège
Clinique Saint-Pierre
Ottignies
GasthuisZusters Antwerpen Sint-Augustinus
Wilrijk
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
Xinqiao Hospital
Chongqing
Fujian Medical University Union Hospital
Fuzhou
Guangdong Provincial People's 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 Affiliated 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 People's Hospital
Wuxi
Henan Cancer Hospital
Zhengzhou
France
Centre Hospitalier Victor Dupouy d'Argenteuil
Argenteuil
Institut Bergonié
Bordeaux
CHU de Caen Côte de Nacre
Caen
Centre Hospitalier Départemental Vendée
La Roche Sur Yon
Centre Hospitalier Le Mans
Le Mans
Centre Hospitalier Universitaire Limoges CHU de Limoges
Limoges
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes
Groupe Hospitalier Pitie-Salpetriere
Paris
Groupe Hospitalier du Haut Leveque
Pessac
Centre hospitalier Lyon Sud
Pierre-bénite
Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
Poitiers Cedex
Hôpital Robert Debré
Reims
Hôpital Pontchaillou
Rennes
Centre Henri-Becquerel
Rouen
Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau
Tours
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandoeuvre-lès-nancy
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia
Presidio Ospedale di Montichiari
Brescia
Presidio Ospedaliero di Gardone Val Trompia
Brescia
Azienda Ospedaliera Universitaria San Martino
Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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 di Roma La Sapienza - Umberto I Policlinico di Roma
Roma
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Azienda Ospedaliera Santa Maria di Terni
Terni
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino
New Zealand
Christchurch Hospital
Christchurch
Auckland City Hospital
Grafton
North Shore Hospital
North Shore
Palmerston North Hospital
Palmerston North
Tauranga Hospital
Tauranga
Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Chorzów
Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii
Gdańsk
Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
Gdynia
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach
Gliwice
Malopolskie Centrum Medyczne
Kraków
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica
Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź
Centrum Onkologii Ziemi Lubelskiej
Lublin
Russian Federation
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg
Kaluga Regional Hospital
Kaluga
Clinical Oncology Dispensary, Kazan
Kazan
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo
City Clinical Hospital No. 52 of the Moscow Healthcare Department
Moscow
N. N. Blokhin Russian Cancer Research Center
Moscow
Nizhniy Novgorod Regional Clinical Hospital N.A.
Nizhny Novgorod
Penza Regional Oncology Dispensary
Penza
Municipal Healthcare Institution Clinical Medical Sanitary Establishment #1
Perm
Ryazan Regional Clinical Hospital
Ryazan
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Sochi
Tula Area Clinical Hospital
Tula
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1
Volgograd
Central City Hospital # 7
Yekaterinburg
Spain
Institut Català d'Oncologia
Badalona
Hospital del Mar
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Institut Català d'Oncologia - L'Hospitalet de Llobregat
Barcelona
Clinica Universidad de Navarra Madrid
Madrid
Hospital Universitario de La Princesa
Madrid
Hospital Universitario Ramón Y Cajal
Madrid
MD Anderson Cancer Center - Madrid
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda
Clínica Universidad de Navarra Pamplona
Pamplona
Hospital Universitari Parc Taulí
Sabadell
Hospital Universitario La Fe
Valencia
Hospital de Día Quirónsalud Zaragoza
Zaragoza
Sweden
Södra Älvsborgs Sjukhus - Borås
Borås
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
Göteborg
Sunderby Sjukhus
Lulea
Skånes Universitetssjukhus i Lund
Lund
Universitetssjukhuset Örebro
Orebro
Karolinska Universitetssjukhuset - Solna
Stockholm
Uppsala Akademiska Sjukhus
Uppsala
Taiwan
Hualien Tzu Chi Hospital
Hualien City
Taipei Medical University - Shuang Ho Hospital
New Taipei City
Chi Mei Hospital Liouying
Tainan City
National Taiwan University Hospital
Taipei
United Kingdom
Heart of England NHS Foundation Trust
Birmingham
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth
Cambridge University Hospitals NHS Foundation Trust
Cambridge
East Kent Hospitals University NHS Foundation Trust
Canterbury
The Leeds Teaching Hospitals NHS Trust
Leeds
Barts and The London NHS Trust
London
Sarah Cannon Research Institute London
London
The Royal Marsden NHS Foundation Trust
London
Maidstone and Tunbridge Wells NHS Trust
Maidstone
The Christie NHS Foundation Trust
Manchester
Norfolk and Norwich University Hospital
Norwich
Nottingham University Hospitals NHS Trust
Nottingham
Derriford Hospital
Plymouth
Southampton General Hospital
Southampton
City Hospitals Sunderland NHS Foundation Trust
Sunderland
The Royal Marsden NHS Foundation Trust
Sutton
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, Nicole Lamanna, Locke Bryan, Mazyar Shadman, Brad Kahl, Charles Farber, Robert Marcus, Solomon Graf, Muhammad-Ali Zaydan, Edwin Kingsley, Donald Quick, Véronique Leblond, Alain Delmer, Fontanet Bijou, Thérése Aurran-Schleinitz, John Gribben, Fritz Offner, Cécile Tomowiak, Sophie De Guibert, Pierre Feugier, Dean Smith, Emmanuelle Ferrant, Marc Andre, Philippe Genet, Bruno Villemagne, Adrian Tempescul, Kamel Laribi, Clemens Schmitt, Stephane Lepretre, Scott Marshall, Béatrice Mahé, Caroline Dartigeas, Christopher Flowers, Suman Kambhampati, Sonja Burgstaller, Agostino Cortelezzi, Michael Steurer, Jadwiga Hołojda, Roberto Foà, Alexander Pristupa, Ching-Yuan Kuo, Wanda Knopińska-Posłuszny, Sergey Semochkin, Michael Fridrik, Francisco Javier López-Jiménez, Andrzej Pluta, Jean-Pierre Vilque, Birgitta Lauri, Wei-Han Huang, Adolfo De La Fuente, Francesco Forconi, Marie-Sarah Dilhuydy, Anna Marina Liberati, Kamil Kaplanov, Nicola Cascavilla, Dariusz Woszczyk, Bertil Uggla, Roberto Marasca, Lukáš Smolej, Per-Ola Andersson, Peter Ganly, Chieh-Lung Cheng, Sergey Voloshin, Michael Leahy, Giuseppe Rossi, Tomas Kozak, Andreas Petzer, Peter Browett, Wojciech Janowski, Sonja Heibl, Peter Hillmen, Eva María González-Barca, Wojciech Jurczak, Marek Trnĕný, Nimish Shah, Paolo Ghia, Gianluigi Reda, Marina Motta, Martin Šimkovič, Gayane Tumyan, Sebastian Grosicki, Sunil Iyengar, Anders Osterborg, Alessandra Tedeschi, Luca Laurenti, Monica Tani, Anne-Sophie Michallet, Emma Verner, Krzysztof Giannopoulos, Helen McCarthy, Richard Greil, George Follows, Tadeusz Robak, David Gottlieb, Marta Coscia, Roman Hájek, Pau Abrisqueta, Uwe Hahn, Dominik Wolf, Constantine Tam, Marco Gobbi, Yung-Cheng Su, Javier Loscertales, Nicholas Weber, Stephen Ting, Catharina Lewerin, Tomáš Papajik, Sebastian Giebel, Stephen Opat, Paula Marlton, Roberto Lemoli, Sheng-Yen Hsiao, Adrian Bloor, Rosemary Harrup, Shankara Paneesha, Gunnar Juliusson, Jiří Mayer
Related Therapeutic Areas
Sponsors
Leads: BeiGene