A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Who is this study for? Adult patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
What treatments are being studied? Zanubrutinib
Status: Completed
Location: See all (109) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
• CLL/SLL requiring treatment per 2008 IWCLL criteria
• Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
• Measurable disease by Computerized Tomography (CT)/magnetic resonance imaging (MRI)
• 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
Arkansas
Carti Cancer Center
Little Rock
California
David Geffen School of Medicine At UCLA
Los Angeles
Colorado
Rocky Mountain Cancer Centers Boulder
Boulder
Florida
Scri Florida Cancer Specialists South
Fort Myers
Scri Florida Cancer Specialists North
Saint Petersburg
Georgia
Augusta University
Augusta
Kansas
Scri Hca Midwest Health
Kansas City
Kentucky
Norton Cancer Institute Pavilion
Louisville
Massachusetts
Dana Farber Cancer Institute
Boston
Mississippi
Forrest General Hospital Cancer Center
Hattiesburg
North Carolina
Duke University Hospital
Durham
Nebraska
Nebraska Medical Center
Omaha
New Jersey
Atlantic Health System
Morristown
Morristown Medical Center
Morristown
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Columbia University Medical Center
New York
Clinical Research Alliance, Inc
Westbury
Oregon
Oregon Health and Science University
Portland
Willamette Valley Cancer Center
Springfield
Tennessee
Scri Tennessee Oncology Chattanooga
Chattanooga
Sarah Cannon Cancer Center
Nashville
Texas
Texas Oncology Fort Worth Cancer Center
Fort Worth
The University of Texas Md Anderson Cancer Center
Houston
Joe Arrington Cancer Research and Treatment Center
Lubbock
Texas Oncology San Antonio Medical Center Usor
San Antonio
Texas Oncology Tyler Longview
Tyler
Virginia
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanoke
Washington
Fred Hutchinson Cancer Research Center
Seattle
Va Puget Sound Health Care System
Seattle
Medical Oncology Associates
Spokane
Other Locations
Australia
Box Hill Hospital
Box Hill
Princess Alexandra Hospital
Brisbane
Monash Health
Clayton
Peninsula Private Hospital
Frankston
Royal Perth Hospital
Perth
Icon Cancer Foundation
South Brisbane
Calvary Mater Newcastle
Waratah
Belgium
Gasthuiszusters Antwerpen Sint Augustinus
Wilrijk
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
Fujian Medical University Union Hospital
Fuzhou
Guangdong Provincial Peoples Hospital
Guangzhou
Nanfang Hospital of Southern Medical University
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Jiangsu Province Hospital
Nanjing
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou
Affiliated Zhongshan Hospital of Fudan University
Shanghai
Tongji Hospital of Tongji University
Shanghai
Shengjing Hospital of China Medical University
Shenyang
Institute of Hematology and Hospital of Blood Disease
Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin
The First Provincial Wenzhou Hospital of Zhejiang
Wenzhou
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Henan Cancer Hospital
Zhengzhou
France
Hopital Prive Sevigne
Cesson Sevigne
Centre Hospitalier Departemental de Vendee
La Roche Sur Yon
Centre Hospitalier Le Mans
Le Mans
Chu Hopital Lyon Sud
Pierrebenite
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
Poitiers
Chu Tours Hopital Bretonneau Service Pneumologie
Tours
Germany
Evangelisches Krankenhaus Hamm
Hamm
Uniklinik Koln (Aor)
Koln
Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano
Ospedale San Raffaele
Milano
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino
Netherlands
Gelre Ziekenhuizen
Apeldoorn
Albert Schweitzer Ziekenhuis
Nijmegen
New Zealand
Middlemore Clinical Trials
Auckland
Christchurch Hospital (Canterbury Health Laboratories)
Christchurch
Waikato Hospital
Hamilton Waikato
North Shore Hospital
Takapuna
Tauranga Hospital
Tauranga
Wellington Regional Hospital (Ccdhb)
Wellington
Poland
Interhem Opieka Szpitalna
Bialystok
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow
Uniwersyteckie Centrum Kliniczne
Gdansk
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdask
Malopolskie Centrum Medyczne Sc
Krakow
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz
Examen Sp Z Oo
Poznan
Spain
Hospital Universitari Germans Trias I Pujol
Badalona
Hospital Clinic I Provincial
Barcelona
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Universitario Vall Dhebron
Barcelona
Ico Girona
Girona
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Universitario Marques de Valdecilla
Santander
Hospital Virgen de La Salud
Toledo
Sweden
Skanes Universitetssjukhus I Lund
Lund
Karolinska Universitetssjukhuset Solna
Stockholm
Turkey
Namik Kemal University
Tekirdag
United Kingdom
Nhs Grampian Ppds
Aberdeen
Birmingham Heartlands Hospital
Birmingham
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth
Kent and Canterbury Hospital
Canterbury
St Jamess Institute of Oncology
Leeds
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
Time Frame
Start Date: 2018-11-01
Completion Date: 2024-02-28
Participants
Target number of participants: 652
Treatments
Experimental: Zanubrutinib
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy
Active_comparator: Ibrutinib
Participants received Ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy
Authors
Shankaranarayana Paneesha, Don Stevens, Robert Ruxer, Bertrand Anz III, Ian Flinn, Benjamin Freeman, Darla Liles, Elizabeth Cull, Seema Bhat, Alexey Danilov, Alessandra Ferrajoli, Leonard Klein, Jennifer Cultrera, Wei Zhang, Michael Thirman, Locke Bryan, Morton Coleman, Mazyar Shadman, Arvind Chaudhry, Syed Zafar, Jay Courtright, John Burke, Kristi McIntyre, Charles Farber, Moshe Levy, Solomon Graf, Leonid Shunyakov, Edwin Kingsley, Ryan Hall, Herbert Eradat, Amanda Gillespie-Twardy, Donald Quick, Cécile Tomowiak, Sophie De Guibert, Emmanuelle Ferrant, Bruno Villemagne, Kamel Laribi, Scott Marshall, Steffen Doerfel, Rudiger Liersch, Caroline Dartigeas, Benoit Bareau, Suman Kambhampati, Jadwiga Holojda, Jaroslaw Piszcz, Gavin Preston, Nicholas Wickham, Henry Chan, Andrzej Pluta, Richard Eek, Francesco Forconi, Rebecca Auer, Nicola Cascavilla, Dariusz Woszczyk, Roberto Marasca, Angel Ramirez Payer, Josep Roncero, Javier Lopez Jimenez, Andrzej Mital, Per-Ola Andersson, Peter Ganly, Zimin Sun, Robert Weinkove, Ling Pan, Peter Hillmen, Wojciech Jurczak, Nimish Shah, Marzia Palma, Paolo Ghia, Keshu ZHOU, Martin Simkovic, Sebastian Grosicki, Xiongpeng Zhu, Jianyu Weng, Alessandra Tedeschi, Luca Laurenti, Ann De Becker, Krzysztof Giannopoulos, Renata Walewska, Tadeusz Robak, Leylagul Kaynar, Patricia Walker, Maciej Kazmierczak, Burhan Turgut, Anna Schuh, Fei Li, Sujun Gao, Roman Hajek, Pau Abrisqueta, Dongmei Yan, Zhuogang Liu, Constantine Tam, Anil Tombak, Kang Yu, Ru Feng, Javier Loscertales, Fevzi Altuntas, Lugui QIU, Julien Depaus, Zengjun Li, Stephen Ting, Huilai Zhang, Piers Patten, Stephen Opat, Paula Marlton, Julio Delgado, Jianda Hu, Peng Liu, Adrian Bloor, Jiri Mayer, Christopher Fox
Related Therapeutic Areas
Sponsors
Leads: BeiGene