CLLPhase 3NCT06073821
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
A Phase 3 study testing Sonrotoclax, Zanubrutinib and Venetoclax in people with CLL, run by BeOne Medicines at 201 sites in 21 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL
- What is being tested?
- Sonrotoclax, Zanubrutinib and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 201 sitesin 21 countries
- Study dates
- 11 Nov 2023to Dec 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
201 sites in 21 countries.
201 sites in 21 countries
United States40 sites
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974
University of Colorado Cancer Center
Aurora, Colorado, 80045-2517
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404-1130
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240
City of Hope National Medical Center
Duarte, California, 91010-3012
Duke University Medical Center
Durham, North Carolina, 27705-3976
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
Gunderson Health System
La Crosse, Wisconsin, 54601-5467
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, 90095-3075
Norton Cancer Institute Pavilion
Louisville, Kentucky, 40207-4700
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
University of Minnesota
Minneapolis, Minnesota, 55455-0341
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429
Columbia University Medical Center
New York, New York, 10032
Southeastern Regional Medical Center
Newnan, Georgia, 30265-8001
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
Stanford Medicine
Palo Alto, California, 94304-2205
Illinois Cancercare, Pc
Peoria, Illinois, 61615-7822
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2434
Virginia Cancer Institute
Richmond, Virginia, 23229-8605
Vcu Health System Massey Comprehensive Cancer Center
Richmond, Virginia, 23298-5004
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Moffitt Cancer Center
Tampa, Florida, 33612-9496
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113
Mission Cancer and Blood
Waukee, Iowa, 50263
Optum Medical Care, Pc
Westbury, New York, 11590-5119
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003
China26 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang, Guangdong, 522000
Shandong Provincial Hospital
Jinan, Shandong, 250000
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203
Nanyang Central Hospital
Nanyang, Henan, 473000
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, 443001
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Japan19 sites
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo, 660-8550
Aomori Prefectural Central Hospital
Aomori, 030-8553
Chiba Cancer Center
Chiba, Chiba, 260-8717
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Tokai University Hospital
Iseharashi, Kanagawa, 259-1193
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Kumamoto University Hospital
Kumamoto, 860-8556
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, 710-8602
Nho Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, 464-8681
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Osaka Metropolitan University Hospital
Osaka, 545-8586
Kindai University Hospital
Sakai, Osaka, 590-0197
Aiiku Hospital
Sapporo, Hokkaido, 064-0804
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855
France13 sites
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
ClermontFerrand, 63100
Clinique Louis Pasteur
Esseylesnancy, 54270
Centre Hospitalier Le Mans
Le Mans, 72037
Chu Lille
Lille, 59037
Centre Leon Berard
Lyon, 69373
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000
Hopital Prive Du Confluent
Nantes, 44200
Hopital de La Pitie Salpetriere
Paris, 75013
Chu Rennes
Rennes Cedes, 35000
Centre Henri Becquerel
Rouen, 76038
Chu Tours Hopital Bretonneau
Tours, 37000
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511
Australia12 sites
Flinders Medical Centre
Bedford PK, South Australia, SA 5042
Pindara Private Hospital
Benowa, Queensland, QLD 4217
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575
Monash Health
Clayton, Victoria, VIC 3168
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065
Austin Health
Heidelberg, Victoria, VIC 3084
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144
The Alfred Hospital
Melbourne, Victoria, VIC 3004
Hollywood Private Hospital
Nedlands, Western Australia, WA 6009
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
Canada10 sites
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec, J4V 2H1
Centre Hospitalier de Luniversite de Montreal (Chum)
Montreal, Quebec, H2X 0C1
Lakeridge Health
Oshawa, Ontario, L1G 2B9
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec, J7Z 5T3
Ciusss de Lestrie Chus
Sherbrooke, Quebec, J1H 5N4
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9
United Kingdom10 sites
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Kent and Canterbury Hospital
Canterbury, CT1 3NG
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE
St Jamess University Hospital
Leeds, LS9 7TF
The Clatterbridge Cancer Centre Liverpool
Liverpool, L7 8YA
University College Hospital
London, NW1 2PG
Kings College
London, SE5 9RS
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY
Southampton General Hospital
Southampton, SO16 6YD
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT
Netherlands9 sites
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
Flevoziekenhuis
Almere Stad, 1315 RA
Meander Medisch Centrum
Amersfoort, 3813 TZ
Amsterdam Umc Vu Mc
Amsterdam, 1081 HV
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
Martini Ziekenhuis
Groningen, 9728 NT
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Franciscus Gasthuis and Vlietland
Schiedam, 3318 JH
Hagaziekenhuis
Sgravenhage, 2545 AA
Spain8 sites
Hospital Universitario de Burgos
Burgos, 09006
Institut Catala Doncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, 8908
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, 35010
Md Anderson Cancer Center Madrid Spain
Madrid, 28033
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital La Candelaria
Santa Cruz de Tenerife, 38010
Italy7 sites
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, 40138
Azienda Ospedaliero Universitaria Di Ferrara
Ferrara, 44124
Istituto Europeo Di Oncologia
Milan, 20141
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Aou Maggiore Della Carita
Novara, 28100
Azienda Ospedaliera Di Padova
Padova, 35128
Ospedale Santa Maria Della Misericordia
Perugia, 6129
Brazil6 sites
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, 18618687
Hospital Erasto Gaertner
Curitiba, 81520-060
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, 14051-140
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
São Paulo, 05403-010
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Czechia6 sites
Fakultni Nemocnice Brno
Brno, 625 00
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03
Fakultni Nemocnice Olomouc
Olomouc, 77900
Fakultni Nemocnice Ostrava
Ostrava, 708 00
Fakultni Nemocnice Plzen
PLZE, 323 00
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
New Zealand6 sites
North Shore Hospital
Auckland, 0622
Auckland City Hospital
Auckland, 1023
Christchurch Hospital
Christchurch, 8011
Dunedin Hospital
Dunedin, 9016
Tauranga Hospital
Tauranga, 3112
Wellington Regional Hospital (Ccdhb)
Wellington, 6021
Poland6 sites
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 61-131
Centralny Szpital Kliniczny Uck Wum
Warsaw, 02-097
Instytut Hematologii I Transfuzjologii W Warszawie
Warsaw, 02-776
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367
South Korea6 sites
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
Israel5 sites
Assuta Ashdod Medical Center
Ashdod, 7747629
Carmel Medical Center
Haifa, 3365409
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah University Hospital Ein Kerem
Jerusalem, 91120
Assuta Medical Center
Tel Aviv, 60000
Turkey (Türkiye)4 sites
Ankara University Medical Faculty
Ankara, 06620
Gazi University
Ankara, 6500
Erciyes University School of Medicine
Kayseri, 38039
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
Austria3 sites
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, 5020
Hanusch Krankenhaus
Vienna, 1140
Germany3 sites
Praxis Am Volkspark
Berlin, 10715
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, 60389
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, 23538
About this study
Official title: 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)
Read the 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.
- Conditions
- CLL
- Being tested
- Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab
- Keywords
- CLL, Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Also called BGB-11417
Administered orally
ZanubrutinibDrug
Also called BGB-3111
Administered orally
VenetoclaxDrug
Administered orally
ObinutuzumabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Sonrotoclax Plus Zanubrutinib | Experimental | 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) Receives: Drug: Sonrotoclax; Drug: Zanubrutinib |
| Venetoclax Plus Obinutuzumab | Active comparator | 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) Receives: Drug: Venetoclax; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Up to one and a half years
Secondary outcomes (16)
Cohort 1: Overall Survival (OS)
OS is defined as time from the date of enrollment to the date of death because of any cause
Measured: Up to approximately 9 years
Cohort 1: Complete Response Rate (CRR ) by IRC
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.
Measured: Up to approximately 9 years
Cohort 1: PFS by Investigator Assessment
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
Measured: Up to approximately 9 years
Cohort 1: CRR by Investigator Assessment
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
Measured: Up to approximately 9 years
Cohort 1: Rate of Undetectable Measurable Residual Disease
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.
Measured: Up to approximately 9 years
Cohort 1: Overall Response Rate (ORR) by IRC and Investigator Assessment
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).
Measured: Up to approximately 9 years
Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment
DOR is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.
Measured: Up to approximately 9 years
Pooled Cohorts: PFS by IRC and Investigator Assessment
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
Measured: Up to approximately 9 years
Pooled Cohorts: ORR by IRC and Investigator Assessment
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）.
Measured: Up to approximately 9 years
Pooled Cohorts: DOR by IRC and Investigator Assessment
DOR is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.
Measured: Up to approximately 9 years
Pooled Cohorts: Rate of Undetectable Measurable Residual Disease
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.
Measured: Up to approximately 9 years
Pooled Cohorts: CRR by IRC and Investigator Assessment
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
Measured: Up to approximately 9 years
Cohort 1 and Pooled Cohorts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Measured: 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
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.
Measured: 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
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.
Measured: 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).
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.
Measured: Every three cycles during the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Nov 2023
- Primary completionFeb 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073821
- Sponsor's protocol ID
- BGB-11417-301
- Other IDs
- CTR20241195
- Status last verified
- Sep 2026
- First submitted
- 3 Oct 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.