A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status: Recruiting
Location: See all (199) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
• Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
• Measurable disease by Computer Tomography/Magnetic Resonance Imaging
• Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
• Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
Locations
United States
Alaska
Alaska Oncology and Hematology, Llc
ACTIVE_NOT_RECRUITING
Anchorage
California
City of Hope National Medical Center
ACTIVE_NOT_RECRUITING
Duarte
University of California San Diego (Ucsd) Moores Cancer Center
ACTIVE_NOT_RECRUITING
La Jolla
UCLA Department of Medicine Hematologyoncology
ACTIVE_NOT_RECRUITING
Los Angeles
Valkyrie Clinical Trials
ACTIVE_NOT_RECRUITING
Los Angeles
Chao Family Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Orange
Stanford Medicine
ACTIVE_NOT_RECRUITING
Palo Alto
Colorado
University of Colorado Cancer Center
ACTIVE_NOT_RECRUITING
Aurora
Washington, D.c.
Medstar Georgetown University Hospital
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Mount Sinai Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Miami Beach
Moffitt Cancer Center
ACTIVE_NOT_RECRUITING
Tampa
Georgia
Southeastern Regional Medical Center
ACTIVE_NOT_RECRUITING
Newnan
Iowa
University of Iowa Hospitals and Clinics
ACTIVE_NOT_RECRUITING
Iowa City
Mission Cancer and Blood
ACTIVE_NOT_RECRUITING
Waukee
Illinois
Northwestern University
ACTIVE_NOT_RECRUITING
Chicago
Illinois Cancercare, Pc
ACTIVE_NOT_RECRUITING
Peoria
Indiana
Fort Wayne Medical Oncology and Hematology
ACTIVE_NOT_RECRUITING
Fort Wayne
Kansas
The University of Kansas Cancer Center
ACTIVE_NOT_RECRUITING
Westwood
Kentucky
Norton Cancer Institute Pavilion
ACTIVE_NOT_RECRUITING
Louisville
Louisiana
Ochsner Clinic Foundation
ACTIVE_NOT_RECRUITING
New Orleans
Minnesota
University of Minnesota
ACTIVE_NOT_RECRUITING
Minneapolis
Missouri
Washington University School of Medicine
ACTIVE_NOT_RECRUITING
St Louis
North Carolina
University of North Carolina At Chapel Hill
ACTIVE_NOT_RECRUITING
Chapel Hill
Atrium Health Levine Cancer Institute (Lci)
ACTIVE_NOT_RECRUITING
Charlotte
Duke University Medical Center
ACTIVE_NOT_RECRUITING
Durham
New Jersey
John Theurer Cancer Center Hackensack University Medical Center
ACTIVE_NOT_RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey
ACTIVE_NOT_RECRUITING
New Brunswick
New York
Columbia University Medical Center
ACTIVE_NOT_RECRUITING
New York
Clinical Research Alliance, Inc
ACTIVE_NOT_RECRUITING
Westbury
Ohio
Cleveland Clinic Foundation
ACTIVE_NOT_RECRUITING
Cleveland
The James Cancer Hospital and Solove Research Institute At Ohio State University
ACTIVE_NOT_RECRUITING
Columbus
Oregon
Oncology Associates of Oregon Willamette Valley Cancer Center
ACTIVE_NOT_RECRUITING
Eugene
Pennsylvania
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
Tennessee
Scri Tennessee Oncology Chattanooga
ACTIVE_NOT_RECRUITING
Chattanooga
Utah
Huntsman Cancer Institute
ACTIVE_NOT_RECRUITING
Salt Lake City
Virginia
Vcu Health Systemmassey Comprehensive Cancer Center
COMPLETED
Richmond
Virginia Cancer Institute
ACTIVE_NOT_RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Research Center
ACTIVE_NOT_RECRUITING
Seattle
Wisconsin
Gunderson Health System
ACTIVE_NOT_RECRUITING
La Crosse
Medical College of Wisconsin
ACTIVE_NOT_RECRUITING
Milwaukee
Other Locations
Australia
Flinders Medical Centre
ACTIVE_NOT_RECRUITING
Bedford Pk
Pindara Private Hospital
ACTIVE_NOT_RECRUITING
Benowa
Sunshine Coast Hospital and Health Service
ACTIVE_NOT_RECRUITING
Birtinya
Monash Health
ACTIVE_NOT_RECRUITING
Clayton
Concord Repatriation General Hospital
ACTIVE_NOT_RECRUITING
Concord
St Vincents Hospital Melbourne
ACTIVE_NOT_RECRUITING
Fitzroy
Austin Health
ACTIVE_NOT_RECRUITING
Heidelberg
Cabrini Hospital Malvern
ACTIVE_NOT_RECRUITING
Malvern East
The Alfred Hospital
ACTIVE_NOT_RECRUITING
Melbourne
Hollywood Private Hospital
ACTIVE_NOT_RECRUITING
Nedlands
Genesiscare North Shore
ACTIVE_NOT_RECRUITING
St Leonards
Princess Alexandra Hospital
ACTIVE_NOT_RECRUITING
Woolloongabba
Austria
Medizinische Universitatsklinik Innsbruck
ACTIVE_NOT_RECRUITING
Innsbruck
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
ACTIVE_NOT_RECRUITING
Salzburg
Hanusch Krankenhaus
ACTIVE_NOT_RECRUITING
Vienna
Brazil
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
ACTIVE_NOT_RECRUITING
Botucatu
Hospital Erasto Gaertner
ACTIVE_NOT_RECRUITING
Curitiba
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
ACTIVE_NOT_RECRUITING
Ribeirão Preto
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
ACTIVE_NOT_RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Arthur Je Child Comprehensive Cancer Centre
ACTIVE_NOT_RECRUITING
Calgary
Cross Cancer Institute
ACTIVE_NOT_RECRUITING
Edmonton
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
ACTIVE_NOT_RECRUITING
Greenfield Park
Centre Hospitalier de Luniversite de Montreal (Chum)
ACTIVE_NOT_RECRUITING
Montreal
Lakeridge Health
ACTIVE_NOT_RECRUITING
Oshawa
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
ACTIVE_NOT_RECRUITING
Québec
Unite de Recherche Clinique Du Cisss Des Laurentides
ACTIVE_NOT_RECRUITING
Saintjerome
Ciusss de Lestrie Chus
ACTIVE_NOT_RECRUITING
Sherbrooke
Princess Margaret Cancer Centre
ACTIVE_NOT_RECRUITING
Toronto
British Columbia Cancer Agency the Vancouver Centre
COMPLETED
Vancouver
Cancercare Manitoba
ACTIVE_NOT_RECRUITING
Winnipeg
China
Peking University Third Hospital
ACTIVE_NOT_RECRUITING
Beijing
The First Peoples Hospital of Changzhou
ACTIVE_NOT_RECRUITING
Changzhou
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital, Sichuan University
ACTIVE_NOT_RECRUITING
Chengdu
Chongqing University Cancer Hospital
ACTIVE_NOT_RECRUITING
Chongqing
Fujian Medical University Union Hospital
ACTIVE_NOT_RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
ACTIVE_NOT_RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
ACTIVE_NOT_RECRUITING
Hefei
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
ACTIVE_NOT_RECRUITING
Jieyang
Shandong Provincial Hospital
ACTIVE_NOT_RECRUITING
Jinan
Jining No Peoples Hospital West Branch
ACTIVE_NOT_RECRUITING
Jining
The Second Affiliated Hospital of Nanchang University
ACTIVE_NOT_RECRUITING
Nanchang
Jiangsu Province Hospital
ACTIVE_NOT_RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
ACTIVE_NOT_RECRUITING
Nanning
Affiliated Hospital of Nantong University
ACTIVE_NOT_RECRUITING
Nantong
Nanyang Central Hospital
ACTIVE_NOT_RECRUITING
Nanyang
The First Hospital of China Medical University
ACTIVE_NOT_RECRUITING
Shenyang
Institute of Hematology and Hospital of Blood Disease
ACTIVE_NOT_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
ACTIVE_NOT_RECRUITING
Wenzhou
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
ACTIVE_NOT_RECRUITING
Wuhan
The Second Affiliated Hospital of Xian Jiaotong University
ACTIVE_NOT_RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
ACTIVE_NOT_RECRUITING
Xuzhou
Yantai Yuhuangding Hospital
ACTIVE_NOT_RECRUITING
Yantai
Yichang Central Peoples Hospitaljiangnan Branch
ACTIVE_NOT_RECRUITING
Yichang
Henan Cancer Hospital
ACTIVE_NOT_RECRUITING
Zhengzhou
France
Centre de Lutte Contre Le Cancer Institut Bergonie
ACTIVE_NOT_RECRUITING
Bordeaux
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
ACTIVE_NOT_RECRUITING
Clermontferrand
Clinique Louis Pasteur
ACTIVE_NOT_RECRUITING
Esseylesnancy
Centre Hospitalier Le Mans
ACTIVE_NOT_RECRUITING
Le Mans
Chu Lille
ACTIVE_NOT_RECRUITING
Lille
Centre Leon Berard
ACTIVE_NOT_RECRUITING
Lyon
Centre Hospitalier Universitaire Nantes Hotel Dieu
ACTIVE_NOT_RECRUITING
Nantes
Hopital Prive Du Confluent
ACTIVE_NOT_RECRUITING
Nantes
Hopital de La Pitie Salpetriere
ACTIVE_NOT_RECRUITING
Paris
Chu Rennes
ACTIVE_NOT_RECRUITING
Rennes Cedes
Centre Henri Becquerel
ACTIVE_NOT_RECRUITING
Rouen
Chu Tours Hopital Bretonneau
ACTIVE_NOT_RECRUITING
Tours
Chu Nancy Hopital Brabois
ACTIVE_NOT_RECRUITING
Vandoeuvrelesnancy
Germany
Praxis Am Volkspark
ACTIVE_NOT_RECRUITING
Berlin
Centrum Fur Haematologie Und Onkologie Bethanien
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Universitaetsklinikum Schleswig Holstein Campus Luebeck
ACTIVE_NOT_RECRUITING
Lübeck
Israel
Assuta Ashdod Medical Center
ACTIVE_NOT_RECRUITING
Ashdod
Carmel Medical Center
ACTIVE_NOT_RECRUITING
Haifa
Hadassah University Hospital Ein Kerem
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Assuta Medical Center
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
ACTIVE_NOT_RECRUITING
Bologna
Azienda Ospedaliero Universitaria Di Ferrara
ACTIVE_NOT_RECRUITING
Ferrara
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
ACTIVE_NOT_RECRUITING
Milan
Istituto Europeo Di Oncologia
ACTIVE_NOT_RECRUITING
Milan
Aou Maggiore Della Carita
ACTIVE_NOT_RECRUITING
Novara
Azienda Ospedaliera Di Padova
ACTIVE_NOT_RECRUITING
Padua
Ospedale Santa Maria Della Misericordia
ACTIVE_NOT_RECRUITING
Perugia
Japan
Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Amagasakicity
Aomori Prefectural Central Hospital
RECRUITING
Aomori
Chiba Cancer Center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chuoku
Kansai Medical University Hospital
RECRUITING
Hirakata
Tokai University Hospital
RECRUITING
Iseharashi
Kagoshima University Hospital
RECRUITING
Kagoshima
Kumamoto University Hospital
RECRUITING
Kumamoto
Kurashiki Central Hospital
RECRUITING
Kurashikishi
Nho Shikoku Cancer Center
RECRUITING
Matsuyama
Aichi Cancer Center Hospital Clinical Oncology
RECRUITING
Nagoya
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Aiiku Hospital
RECRUITING
Sapporo
Kindai University Hospital
RECRUITING
Sayama
Tohoku University Hospital
RECRUITING
Sendai
Yamagata University Hospital
RECRUITING
Yamagata
Yokohama Municipal Citizens Hospital
RECRUITING
Yokohama
Netherlands
Noordwest Ziekenhuisgroep
ACTIVE_NOT_RECRUITING
Alkmaar
Flevoziekenhuis
ACTIVE_NOT_RECRUITING
Almere Stad
Meander Medisch Centrum
ACTIVE_NOT_RECRUITING
Amersfoort
Amsterdam Umc Vu Mc
ACTIVE_NOT_RECRUITING
Amsterdam
Reinier de Graaf Gasthuis
COMPLETED
Delft
Albert Schweitzer Ziekenhuis
ACTIVE_NOT_RECRUITING
Dordrecht
Martini Ziekenhuis
ACTIVE_NOT_RECRUITING
Groningen
Ikazia Ziekenhuis
ACTIVE_NOT_RECRUITING
Rotterdam
Maasstad Hospital
COMPLETED
Rotterdam
Franciscus Gasthuis and Vlietland
ACTIVE_NOT_RECRUITING
Schiedam
Hagaziekenhuis
ACTIVE_NOT_RECRUITING
Sgravenhage
Elisabeth Tweesteden Ziekenhuis
COMPLETED
Tilburg
New Zealand
Auckland City Hospital
ACTIVE_NOT_RECRUITING
Auckland
North Shore Hospital
ACTIVE_NOT_RECRUITING
Auckland
Health New Zealand Canterbury
ACTIVE_NOT_RECRUITING
Christchurch
Dunedin Hospital
ACTIVE_NOT_RECRUITING
Dunedin
Tauranga Hospital
ACTIVE_NOT_RECRUITING
Tauranga
Wellington Regional Hospital (Ccdhb)
ACTIVE_NOT_RECRUITING
Wellington
Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
ACTIVE_NOT_RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr W Lublinie
ACTIVE_NOT_RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny
ACTIVE_NOT_RECRUITING
Poznan
Centralny Szpital Kliniczny Uck Wum
ACTIVE_NOT_RECRUITING
Warsaw
Instytut Hematologii I Transfuzjologii
ACTIVE_NOT_RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
ACTIVE_NOT_RECRUITING
Wroclaw
Puerto Rico
Auxilio Mutuo Cancer Center
ACTIVE_NOT_RECRUITING
San Juan
Republic of Korea
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Bundanggu Seongnamsi
National Cancer Center (Korea)
ACTIVE_NOT_RECRUITING
Ilsandonggu Goyangsi
The Catholic University of Korea, Seoul St Marys Hospital
ACTIVE_NOT_RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
ACTIVE_NOT_RECRUITING
Seodaemungu
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Asan Medical Center
ACTIVE_NOT_RECRUITING
Songpagu
Spain
Hospital Universitario de Burgos
ACTIVE_NOT_RECRUITING
Burgos
Institut Catala Doncologia Hospital Duran I Reynals
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Gran Canaria Dr Negrin
ACTIVE_NOT_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de Octubre
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramon Y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Md Anderson Cancer Center Madrid Spain
ACTIVE_NOT_RECRUITING
Madrid
Hospital La Candelaria
ACTIVE_NOT_RECRUITING
Santa Cruz De Tenerife
Sweden
Karolinska Universitetssjukhuset Solna
ACTIVE_NOT_RECRUITING
Stockholm
Turkey
Ankara University Medical Faculty
ACTIVE_NOT_RECRUITING
Ankara
Gazi University
ACTIVE_NOT_RECRUITING
Ankara
Erciyes University School of Medicine
ACTIVE_NOT_RECRUITING
Kayseri
Kocaeli Universitesi Tip Fakultesi
ACTIVE_NOT_RECRUITING
Kocaeli
United Kingdom
University Hospitals Dorset Royal Bournemouth Hospital
ACTIVE_NOT_RECRUITING
Bournemouth
Kent and Canterbury Hospital
ACTIVE_NOT_RECRUITING
Canterbury
Churchill Hospital Oxford University Hospital Nhs Trust
ACTIVE_NOT_RECRUITING
Headington
St Jamess University Hospital
ACTIVE_NOT_RECRUITING
Leeds
The Clatterbridge Cancer Centre Liverpool
ACTIVE_NOT_RECRUITING
Liverpool
Kings College
ACTIVE_NOT_RECRUITING
London
University College Hospital
ACTIVE_NOT_RECRUITING
London
Norfolk and Norwich University Hospitals Nhs Foundation Trust
ACTIVE_NOT_RECRUITING
Norwich
Southampton General Hospital
ACTIVE_NOT_RECRUITING
Southampton
Royal Marsden Nhs Foundation Royal Marsden Hospital
ACTIVE_NOT_RECRUITING
Sutton
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1-877-828-5568
Time Frame
Start Date: 2023-11-11
Estimated Completion Date: 2032-12
Participants
Target number of participants: 652
Treatments
Experimental: Sonrotoclax Plus Zanubrutinib
Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)
Active_comparator: Venetoclax Plus Obinutuzumab
Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)
Related Therapeutic Areas
Sponsors
Leads: BeiGene