Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
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
2 other identifiers
interventional
652
20 countries
189
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
November 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
April 22, 2026
April 1, 2026
8.2 years
October 3, 2023
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohort 1: Progression Free Survival (PFS）
PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by independent review committee (IRC)
Up to approximately 9 years
Cohort 1: Rate of Undetectable Measurable Residual Disease
Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.
Up to one and a half years
Secondary Outcomes (16)
Cohort 1: Complete Response Rate (CRR ) by IRC
Up to approximately 9 years
Cohort 1: Overall Survival (OS)
Up to approximately 9 years
Cohort 1: PFS by Investigator Assessment
Up to approximately 9 years
Cohort 1: CRR by Investigator Assessment
Up to approximately 9 years
Cohort 1: Rate of Undetectable Measurable Residual Disease
Up to approximately 9 years
- +11 more secondary outcomes
Study Arms (2)
Sonrotoclax Plus Zanubrutinib
EXPERIMENTALParticipants 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)
Venetoclax Plus Obinutuzumab
ACTIVE COMPARATORParticipants 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous systemic treatment for CLL
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (201)
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974, United States
City of Hope National Medical Center
Duarte, California, 91010-3012, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, 90095-3075, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201, United States
Stanford Medicine
Palo Alto, California, 94304-2205, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045-2517, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140, United States
Moffitt Cancer Center
Tampa, Florida, 33612-9496, United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265-8001, United States
Northwestern University
Chicago, Illinois, 60611, United States
Illinois Cancercare, Pc
Peoria, Illinois, 61615-7822, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009, United States
Mission Cancer and Blood
Waukee, Iowa, 50263, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003, United States
Norton Cancer Institute Pavilion
Louisville, Kentucky, 40207-4700, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429, United States
University of Minnesota
Minneapolis, Minnesota, 55455-0341, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914, United States
Columbia University Medical Center
New York, New York, 10032, United States
Clinical Research Alliance, Inc
Westbury, New York, 11590-5119, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990, United States
Duke University Medical Center
Durham, North Carolina, 27705-3976, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2434, United States
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404-1130, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Virginia Cancer Institute
Richmond, Virginia, 23229-8605, United States
Vcu Health Systemmassey Comprehensive Cancer Center
Richmond, Virginia, 23298-5004, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433, United States
Gunderson Health System
La Crosse, Wisconsin, 54601-5467, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222, United States
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
Pindara Private Hospital
Benowa, Queensland, QLD 4217, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
Flinders Medical Centre
Bedford PK, South Australia, SA 5042, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, VIC 3144, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Hollywood Private Hospital
Nedlands, Western Australia, WA 6009, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Hanusch Krankenhaus
Vienna, 1140, Austria
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, 18618687, Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, 14051-140, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, 05402-000, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Hospitalier de Luniversite de Montreal (Chum)
Montreal, Quebec, H2X 0C1, Canada
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec, J7Z 5T3, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, J1H 5N4, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4, Canada
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang, Guangdong, 522000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, 443001, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Fakultni Nemocnice Brno
Brno, 625 00, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 00, Czechia
Fakultni Nemocnice Plzen
PLZE, 323 00, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000, Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000, France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, 63100, France
Clinique Louis Pasteur
Esseylesnancy, 54270, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Chu Lille
Lille, 59037, France
Centre Leon Berard
Lyon, 69373, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000, France
Hopital Prive Du Confluent
Nantes, 44200, France
Hopital de La Pitie Salpetriere
Paris, 75013, France
Chu Rennes
Rennes Cedes, 35000, France
Centre Henri Becquerel
Rouen, 76038, France
Chu Tours Hopital Bretonneau
Tours, 37000, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511, France
Praxis Am Volkspark
Berlin, 10715, Germany
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, 60389, Germany
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, 23538, Germany
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Carmel Medical Center
Haifa, 3365409, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Assuta Medical Center
Tel Aviv, 60000, Israel
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Di Ferrara
Ferrara, 44124, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Aou Maggiore Della Carita
Novara, 28100, Italy
Azienda Ospedaliera Di Padova
Padova, 35128, Italy
Ospedale Santa Maria Della Misericordia
Perugia, 6129, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, 464-8681, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Aiiku Hospital
Sapporo, Hokkaido, 064-0804, Japan
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo, 660-8550, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
Tokai University Hospital
Iseharashi, Kanagawa, 259-1193, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, 710-8602, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Aomori Prefectural Central Hospital
Aomori, 030-8553, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855, Japan
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
Flevoziekenhuis
Almere Stad, 1315 RA, Netherlands
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Amsterdam Umc Vu Mc
Amsterdam, 1081 HV, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
Franciscus Gasthuis and Vlietland
Schiedam, 3318 JH, Netherlands
Hagaziekenhuis
Sgravenhage, 2545 AA, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-513, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 61-131, Poland
Centralny Szpital Kliniczny Uck Wum
Warsaw, 02-097, Poland
Instytut Hematologii I Transfuzjologii W Warszawie
Warsaw, 02-776, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367, Poland
Auxilio Mutuo Cancer Center
San Juan, 00917, Puerto Rico
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Hospital Universitario de Burgos
Burgos, 09006, Spain
Institut Catala Doncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, 8908, Spain
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, 35010, Spain
Md Anderson Cancer Center Madrid Spain
Madrid, 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital La Candelaria
Santa Cruz de Tenerife, 38010, Spain
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Ankara University Medical Faculty
Ankara, 06620, Turkey (Türkiye)
Gazi University
Ankara, 6500, Turkey (Türkiye)
Erciyes University School of Medicine
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE, United Kingdom
St Jamess University Hospital
Leeds, LS9 7TF, United Kingdom
The Clatterbridge Cancer Centre Liverpool
Liverpool, L7 8YA, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
Kings College
London, SE5 9RS, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 10, 2023
Study Start
November 11, 2023
Primary Completion (Estimated)
February 1, 2032
Study Completion (Estimated)
December 1, 2032
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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