Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT06073821
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
652 participants
INTERVENTIONAL
2023-11-11
2032-12-31
Brief Summary
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Detailed Description
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In this study, participants with CLL without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.
The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
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)
Venetoclax
Administered orally
Obinutuzumab
Administered intravenously
Interventions
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Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Venetoclax
Administered orally
Obinutuzumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
* Known central nervous system involvement
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Uncontrolled hypertension
Note: Other protocol defined criteria may apply
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Locations
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Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Medicine
Palo Alto, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Illinois Cancercare, Pc
Peoria, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mission Cancer and Blood
Waukee, Iowa, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute Pavilion
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Vcu Health Systemmassey Comprehensive Cancer Center
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Gunderson Health System
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, , Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, , Austria
Hanusch Krankenhaus
Vienna, , Austria
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, , Brazil
Hospital Erasto Gaertner
Curitiba, , Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, , Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, , Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec, Canada
Centre Hospitalier de Luniversite de Montreal (Chum)
Montreal, Quebec, Canada
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, , Canada
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Nanyang Central Hospital
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Jining No Peoples Hospital West Branch
Jining, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fakultni Nemocnice Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Fakultni Nemocnice Plzen
PLZE, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, , France
Clinique Louis Pasteur
Esseylesnancy, , France
Centre Hospitalier Le Mans
Le Mans, , France
Chu Lille
Lille, , France
Centre Leon Berard
Lyon, , France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, , France
Hopital Prive Du Confluent
Nantes, , France
Hopital de La Pitie Salpetriere
Paris, , France
Chu Rennes
Rennes Cedes, , France
Centre Henri Becquerel
Rouen, , France
Chu Tours Hopital Bretonneau
Tours, , France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, , France
Praxis Am Volkspark
Berlin, , Germany
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, , Germany
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, , Germany
Assuta Ashdod Medical Center
Ashdod, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital Ein Kerem
Jerusalem, , Israel
Assuta Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, , Italy
Azienda Ospedaliero Universitaria Di Ferrara
Ferrara, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Aou Maggiore Della Carita
Novara, , Italy
Azienda Ospedaliera Di Padova
Padua, , Italy
Ospedale Santa Maria Della Misericordia
Perugia, , Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital
Iseharashi, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Aomori Prefectural Central Hospital
Aomori, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Yokohama Municipal Citizens Hospital
Yokohama, , Japan
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Amsterdam Umc Vu Mc
Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Maasstad Hospital
Rotterdam, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Franciscus Gasthuis and Vlietland
Schiedam, , Netherlands
Hagaziekenhuis
Sgravenhage, , Netherlands
North Shore Hospital
Auckland, , New Zealand
Auckland City Hospital
Auckland, , New Zealand
Health New Zealand Canterbury
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, , New Zealand
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, , Poland
Uniwersytecki Szpital Kliniczny Nr W Lublinie
Lublin, , Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, , Poland
Centralny Szpital Kliniczny Uck Wum
Warsaw, , Poland
Instytut Hematologii I Transfuzjologii
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, , Poland
Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario de Burgos
Burgos, , Spain
Institut Catala Doncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, , Spain
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, , Spain
Md Anderson Cancer Center Madrid Spain
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital La Candelaria
Santa Cruz de Tenerife, , Spain
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University
Ankara, , Turkey (Türkiye)
Erciyes University School of Medicine
Kayseri, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
St Jamess University Hospital
Leeds, , United Kingdom
The Clatterbridge Cancer Centre Liverpool
Liverpool, , United Kingdom
University College Hospital
London, , United Kingdom
Kings College
London, , United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Other Identifiers
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CTR20241195
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-11417-301
Identifier Type: -
Identifier Source: org_study_id