Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

August 6, 2026 updated by: BeOne Medicines

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

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.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Study Type

Interventional

Enrollment (Estimated)

652

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Concord Repatriation General Hospital
      • St Leonards, New South Wales, Australia, NSW 2065
        • GenesisCare North Shore
    • Queensland
      • Benowa, Queensland, Australia, QLD 4217
        • Pindara Private Hospital
      • Birtinya, Queensland, Australia, QLD 4575
        • Sunshine Coast Hospital and Health Service
      • Woolloongabba, Queensland, Australia, QLD 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford PK, South Australia, Australia, SA 5042
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • Fitzroy, Victoria, Australia, VIC 3065
        • St Vincents Hospital Melbourne
      • Heidelberg, Victoria, Australia, VIC 3084
        • Austin Health
      • Malvern, Victoria, Australia, VIC 3144
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, VIC 3004
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Hollywood Private Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitatsklinik Innsbruck
      • Salzburg, Austria, 5020
        • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus
  • Brazil
      • Botucatu, Brazil, 18618687
        • Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
      • Curitiba, Brazil, 81520-060
        • Hospital Erasto Gaertner
      • Porto Alegre, Brazil, 90110-270
        • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
      • Ribeirão Preto, Brazil, 14051-140
        • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
      • São Paulo, Brazil, 05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo, Brazil, 05402-000
        • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
  • Canada
      • Québec, Canada, G1J 1Z4
        • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur JE Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de Luniversite de Montreal (Chum)
      • SaintJerome, Quebec, Canada, J7Z 5T3
        • Unité de Recherche Clinique du CISSS des Laurentides
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Ciusss de Lestrie Chus
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking University Third Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University
      • Jieyang, Guangdong, China, 522000
        • Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Henan
      • Nanyang, Henan, China, 473000
        • Nanyang Central Hospital
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
      • Yichang, Hubei, China, 443001
        • Yichang Central Peoples Hospitaljiangnan Branch
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The First Peoples Hospital of Changzhou
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nantong, Jiangsu, China, 201203
        • Affiliated Hospital of Nantong University
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong Provincial Hospital
      • Jining, Shandong, China, 272000
        • Jining No1 Peoples Hospital West Branch
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610071
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology and Hospital of Blood Disease
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultní Nemocnice Brno
      • Hradec Králové, Czechia, 500 03
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc
      • Ostrava, Czechia, 708 00
        • Fakultni nemocnice Ostrava
      • PLZE, Czechia, 323 00
        • Fakultni nemocnice Plzen
      • Prague, Czechia, 10000
        • Vseobecna Fakultni nemocnice v Praze
  • France
      • Bordeaux, France, 33076
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • ClermontFerrand, France, 63100
        • Chu Clermont Ferrand Therapie Cellulaire and Hematolo
      • Esseylesnancy, France, 54270
        • Clinique Louis Pasteur
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Lille, France, 59037
        • CHU Lille
      • Lyon, France, 69373
        • Centre Leon Berard
      • Nantes, France, 44200
        • Hopital Prive du Confluent
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Paris, France, 75013
        • Hôpital de la Pitié Salpêtrière
      • Rennes Cedes, France, 35000
        • CHU Rennes
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Tours, France, 37000
        • Chu Tours Hopital Bretonneau
      • VandoeuvrelesNancy, France, 54511
        • Chu Nancy Hopital Brabois
  • Germany
      • Berlin, Germany, 10715
        • Praxis am Volkspark
      • Frankfurt am Main, Germany, 60389
        • Centrum Fur Haematologie Und Onkologie Bethanien
      • Lübeck, Germany, 23538
        • Universitaetsklinikum Schleswig Holstein Campus Luebeck
  • Israel
      • Ashdod, Israel, 7747629
        • Assuta Ashdod Medical Center
      • Haifa, Israel, 3365409
        • Carmel Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital Ein Kerem
      • Tel Aviv, Israel, 60000
        • Assuta Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
      • Ferrara, Italy, 44124
        • Azienda ospedaliero Universitaria di Ferrara
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Novara, Italy, 28100
        • Aou Maggiore Della Carita
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Perugia, Italy, 6129
        • Ospedale Santa Maria della Misericordia
  • Japan
      • Aomori, Japan, 030-8553
        • Aomori Prefectural Central Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan university Hospital
      • Yokohama, Japan, 221-0855
        • Yokohama Municipal Citizens Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center Hospital Clinical Oncology
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba cancer center
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0804
        • Aiiku Hospital
    • Hyōgo
      • AmagasakiCity, Hyōgo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital
    • Kanagawa
      • Iseharashi, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
    • Okayama-ken
      • Kurashikishi, Okayama-ken, Japan, 710-8602
        • Kurashiki Central Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital
    • Tokyo
      • ChuoKu, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Noordwest Ziekenhuisgroep
      • Almere Stad, Netherlands, 1315 RA
        • Flevoziekenhuis
      • Amersfoort, Netherlands, 3813 TZ
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam Umc Vu Mc
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Groningen, Netherlands, 9728 NT
        • Martini Ziekenhuis
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
      • Schiedam, Netherlands, 3318 JH
        • Franciscus Gasthuis and Vlietland
      • Sgravenhage, Netherlands, 2545 AA
        • Hagaziekenhuis
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Auckland, New Zealand, 0622
        • North Shore Hospital
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Tauranga, New Zealand, 3112
        • Tauranga Hospital
      • Wellington, New Zealand, 6021
        • Wellington Regional Hospital (Ccdhb)
  • Poland
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
      • Lublin, Poland, 20-090
        • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
      • Poznan, Poland, 61-131
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Poland, 02-776
        • Instytut Hematologii I Transfuzjologii W Warszawie
      • Warsaw, Poland, 02-097
        • Centralny Szpital Kliniczny UCK WUM
      • Wroclaw, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Auxilio Mutuo Cancer Center
  • South Korea
    • Gyeonggi-do
      • IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408
        • National Cancer Center (Korea)
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Seoul Teugbyeolsi
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St Marys Hospital
      • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital
      • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center
  • Spain
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • L'Hospitalet de Llobregat, Spain, 8908
        • Institut Catala Doncologia Hospital Duran I Reynals
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr Negrin
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28033
        • Md Anderson Cancer Center Madrid Spain
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital La Candelaria
  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06620
        • Ankara University Medical Faculty
      • Ankara, Turkey (Türkiye), 6500
        • Gazi University
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes University School of Medicine
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • University Hospitals Dorset Royal Bournemouth Hospital
      • Canterbury, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Headington, United Kingdom, OX3 7LE
        • Oxford University Hospitals Nhs Trust Churchill Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St Jamess University Hospital
      • Liverpool, United Kingdom, L7 8YA
        • The Clatterbridge Cancer Centre Liverpool
      • London, United Kingdom, NW1 2PG
        • University College Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Nhs Foundation Royal Marsden Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508-2974
        • Alaska Oncology and Hematology, LLC
    • California
      • Duarte, California, United States, 91010-3012
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92093-1503
        • University of California San Diego (Ucsd) Moores Cancer Center
      • Los Angeles, California, United States, 90067-2011
        • Valkyrie Clinical Trials
      • Los Angeles, California, United States, 90095-3075
        • UCLA Department of Medicine Hematologyoncology
      • Orange, California, United States, 92868-3201
        • Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304-2205
        • Stanford Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • University Of Colorado Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007-2113
        • MedStar Georgetown University Hospital
    • Florida
      • Miami, Florida, United States, 33140
        • Mount Sinai Medical Center Braman Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612-9496
        • Moffitt Cancer Center
    • Georgia
      • Newnan, Georgia, United States, 30265-8001
        • Southeastern Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Peoria, Illinois, United States, 61615-7822
        • Illinois Cancercare, Pc
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • University of Iowa Hospitals and Clinics
      • Waukee, Iowa, United States, 50263
        • Mission Cancer and Blood
    • Kansas
      • Westwood, Kansas, United States, 66205-2003
        • The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207-4700
        • Norton Cancer Institute Pavilion
    • Louisiana
      • New Orleans, Louisiana, United States, 70121-2429
        • Ochsner Clinic Foundation
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0341
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901-1914
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center
      • Westbury, New York, United States, 11590-5119
        • Optum Medical Care, PC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514-4220
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204-2990
        • Atrium Health Levine Cancer Institute (Lci)
      • Durham, North Carolina, United States, 27705-3976
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210-1240
        • The James Cancer Hospital and Solove Research Institute At Ohio State University
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon Willamette Valley Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2434
        • Fox Chase Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-1130
        • Scri Tennessee Oncology Chattanooga
    • Utah
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Virginia
      • Richmond, Virginia, United States, 23229-8605
        • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23298-5004
        • Vcu Health System Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109-4433
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601-5467
        • Gunderson Health System
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Sonrotoclax
Administered orally
Other Names:
  • BGB-11417
Drug: Zanubrutinib
Administered orally
Other Names:
  • BGB-3111
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)
Drug: Obinutuzumab
Administered intravenously
Drug: Venetoclax
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Progression Free Survival (PFS）
Time Frame: Up to approximately 9 years
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
Time Frame: Up to one and a half years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Complete Response Rate (CRR ) by IRC
Time Frame: Up to approximately 9 years
CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by IRC.
Up to approximately 9 years
Cohort 1: Overall Survival (OS)
Time Frame: Up to approximately 9 years
OS is defined as time from the date of enrollment to the date of death because of any cause
Up to approximately 9 years
Cohort 1: PFS by Investigator Assessment
Time Frame: Up to approximately 9 years
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 investigator assessment
Up to approximately 9 years
Cohort 1: CRR by Investigator Assessment
Time Frame: Up to approximately 9 years
CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by Investigator Assessment
Up to approximately 9 years
Cohort 1: Rate of Undetectable Measurable Residual Disease
Time Frame: Up to approximately 9 years
The overall uMRD4 rate is defined as the percentage of participants who achieve uMRD status in peripheral blood before disease progression or start of new anti-CLL treatment (whichever is earlier), based on flow cytometry.
Up to approximately 9 years
Cohort 1: Overall Response Rate (ORR) by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
ORR is defined as the percentage of participants who achieve a response (CR, CRi, nodular partial remission (nPR), partial response (PR), and partial response with lymphocytosis [PR-L]), before disease progression or start of new anti-CLL treatment (whichever is earlier).
Up to approximately 9 years
Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
DOR is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.
Up to approximately 9 years
Pooled Cohorts: PFS by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
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 IRC
Up to approximately 9 years
Pooled Cohorts: ORR by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
ORR is defined as the percentage of participants who achieve a response (CR, CRi, nodular partial remission (nPR), partial response (PR), and partial response with lymphocytosis [PR-L]), before disease progression or start of new anti-CLL treatment （whichever is earlier）.
Up to approximately 9 years
Pooled Cohorts: DOR by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
DOR is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.
Up to approximately 9 years
Pooled Cohorts: Rate of Undetectable Measurable Residual Disease
Time Frame: Up to approximately 9 years
The overall uMRD4 rate is defined as the percentage of participants who achieve uMRD status in peripheral blood before disease progression or start of new anti-CLL treatment (whichever is earlier),based on next-generation sequencing.
Up to approximately 9 years
Pooled Cohorts: CRR by IRC and Investigator Assessment
Time Frame: Up to approximately 9 years
CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by Investigator Assessment
Up to approximately 9 years
Cohort 1 and Pooled Cohorts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to one and a half years for Sonrotoclax Plus Zanubrutinib group and 13 months for Venetoclax Plus Obinutuzumab group]
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Up to one and a half years for Sonrotoclax Plus Zanubrutinib group and 13 months for Venetoclax Plus Obinutuzumab group]
Cohort 1 and Pooled Cohorts: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales
Time Frame: Every three cycles during the treatment period
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in GHS and functional scales indicate better quality of life.
Every three cycles during the treatment period
Cohort 1 and Pooled Cohorts: Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales
Time Frame: Every three cycles during the treatment period
The symptom burden and physical condition/fatigue will be measured by EQ-5D-5L. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.
Every three cycles during the treatment period
Cohort 1 and Pooled Cohorts: Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire （EQ-5D-5L) Visual Analogue Scale (VAS).
Time Frame: Every three cycles during the treatment period
Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine. A higher score indicates better health outcomes.
Every three cycles during the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-11417-301
  • CTR20241195 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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