Chronic Lymphocytic LeukemiaPhase 3NCT07277231
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3 study testing Sonrotoclax, Zanubrutinib and Acalabrutinib in people with Chronic Lymphocytic Leukemia, run by BeOne Medicines at 115 sites in 17 countries.
Trial summary
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Sonrotoclax, Zanubrutinib and Acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 115 sitesin 17 countries
- Study dates
- 22 Jan 2026to Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 bone marrow and organ function
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 or clinically significant cardiovascular disease
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
115 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
115 sites in 17 countries
United States22 sites, 22 recruiting
- Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, 80012-5405
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
- Recruiting
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010-3012
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705-3976
- Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865
- Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, 33140
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429
- Recruiting
Columbia University Medical Center
New York, New York, 10032
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
- Recruiting
Stanford Cancer Institute
Palo Alto, California, 94304-2205
- Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612-9496
- Recruiting
Texas Oncology Tyler
Tyler, Texas, 75702-7522
- Recruiting
Midwestern Regional Medical Center
Zion, Illinois, 60099-2676
China20 sites, 19 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Active, not recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
- Recruiting
Sun Yat Sen University Cancer Center Huangpu Branch
Guangzhou, Guangdong, 510555
- Recruiting
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, 550002
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203
- Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020
- Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Australia8 sites, 8 recruiting
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
- Recruiting
Monash Health
Clayton, Victoria, VIC 3168
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139
- Recruiting
Austin Health
Heidelberg, Victoria, VIC 3084
- Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144
- Recruiting
The Alfred Hospital
Melbourne, Victoria, VIC 3004
- Recruiting
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
France7 sites, 7 recruiting
- Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
- Recruiting
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
ClermontFerrand, 63100
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72037
- Recruiting
Hopital Claude Huriez Chu Lille
Lille, 59000
- Recruiting
Centre Leon Berard
Lyon, 69373
- Recruiting
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090
- Recruiting
Iuc Toulouse Oncopole
Toulouse, 31100
Canada6 sites, 6 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
- Recruiting
Ciusss Nim Hscm
Montreal, Quebec, H4J 1C5
- Recruiting
Jewish General Hospital
Montreal, Quebec, QC H3t 1E2
- Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Quebec, G1J 1Z4
- Recruiting
Ciusss de Lestrie Chus
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Bc Cancer Victoria
Victoria, British Columbia, V8R 6V5
Czechia6 sites, 6 recruiting
- Recruiting
Fakultni Nemocnice Brno
Brno, 625 00
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03
- Recruiting
Fakultni Nemocnice Olomouc
Olomouc, 77900
- Recruiting
Fakultni Nemocnice Ostrava
Ostrava, 708 00
- Recruiting
Fakultni Nemocnice Plzen
PLZE, 323 00
- Recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
Italy6 sites, 6 recruiting
- Recruiting
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138
- Recruiting
Aou Careggi, Servizio Sanitario Toscana
Florence, 50134
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Azienda Ospedaliera Di Padova
Padova, 35128
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Brazil5 sites, 5 recruiting
- Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140
- Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
- Recruiting
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, 41950-640
- Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
New Zealand5 sites, 5 recruiting
- Recruiting
North Shore Hospital
Auckland, 0622
- Recruiting
Auckland City Hospital
Auckland, 1023
- Recruiting
Health New Zealand Canterbury
Christchurch, 8011
- Recruiting
Dunedin Hospital
Dunedin, 9016
- Recruiting
Wellington Regional Hospital (Ccdhb)
Wellington, 6021
Poland5 sites, 5 recruiting
- Recruiting
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200
- Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Recruiting
Pratia McM Krakow
Krakow, 30-727
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090
- Recruiting
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367
South Korea5 sites, 5 recruiting
- Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
- Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
United Kingdom5 sites, 5 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham, B15 2TH
- Recruiting
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, BH7 7DW
- Recruiting
St Jamess University Hospital
Leeds, LS9 7TF
- Recruiting
Kings College Hospital
London, SE5 9RS
- Recruiting
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY
Germany4 sites, 4 recruiting
- Recruiting
Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie
Deggendorf, 94469
- Recruiting
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, 60389
- Recruiting
Geho Munster
Münster, 48153
- Recruiting
Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh
Straubing, 94315
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Virgen de Las Nieves
Granada, 18014
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
- Recruiting
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, 30120
Netherlands3 sites, 3 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad, 1315 RA
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
- Recruiting
Hagaziekenhuis
Sgravenhage, 2545 AA
Romania3 sites, 3 recruiting
- Recruiting
Coltea Clinical Hospital
Bucharest, 30171
- Recruiting
Institutul Clinic Fundeni
Bucureti, 022328
- Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, 400015
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
About this study
Official title: A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Sonrotoclax, Zanubrutinib, Acalabrutinib, Venetoclax
- Keywords
- B-cell Lymphoma-2 Inhibitor, Bruton Tyrosine Kinase Inhibitor
- 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, Brukinsa
Administered orally.
AcalabrutinibDrug
Also called Calquence
Administered orally.
VenetoclaxDrug
Also called Venclexta, Venclyxto
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sonrotoclax plus Zanubrutinib | Experimental | Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation. Receives: Drug: Sonrotoclax; Drug: Zanubrutinib |
| Arm B: Venetoclax plus Acalabrutinib | Active comparator | Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation. Receives: Drug: Acalabrutinib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Measured: Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
Measured: Up to approximately 16 months
Secondary outcomes (11)
PFS in High-Risk Participants
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Measured: Up to approximately 70 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 70 months
Overall Response Rate (ORR) as Determined by IRC
ORR is defined as the percentage of participants with a complete response (CR), complete response with incomplete hematopoietic recovery (CRi), nodal partial response (nPR), or partial response (PR), before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by IRC.
Measured: Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Rate of uMRD5 is defined as the percentage of participants who achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier).
Measured: Up to approximately 16 months
Number of Participants with Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of clinical interest, and serious adverse events (SAEs), including laboratory values, vital signs, and physical examination findings.
Measured: Up to approximately 70 months
PFS Determined by Investigator Assessment
PFS is defined as the time from the date of randomization to the date of disease progression as determined by investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 70 months
Complete Response Rate (CRR) by IRC and Investigator Assessment
CRR is defined as the percentage of participants with a CR or CRi before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier).
Measured: Up to approximately 70 months
ORR Determined by Investigator Assessment
ORR is defined as the percentage of participants with a complete response or partial response, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by investigator.
Measured: Up to approximately 70 months
Duration of Response (DOR)
Duration of response (determined by both IRC and investigator assessment) is defined as the time from the first qualifying response (CR, CRi, nPR, or PR) until CLL progression or death. DOR analysis will only include responders.
Measured: Up to approximately 70 months
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of the next treatment for CLL.
Measured: Up to approximately 70 months
Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire
Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 (an itemized version of [EORTC] quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17). The EORTC-IL-409 consists of 17 questions answered on a 4-point scale where 1 = Not at all (best) to 4 = Very Much (worst) and 2 global health questions answered on a 7-point scale where 1 = Very poor (worst) to 7 = Excellent (best). Higher scores in GHS and functional scales and lower scores in symptom scales indicate better quality of life.
Measured: At baseline and up to approximately 70 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start22 Jan 2026
- Primary completionFeb 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277231
- Sponsor's protocol ID
- BGB-11417-304
- Other IDs
- 2025-524366-21-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT07277231
- Acronym / sponsor ID
- BGB-11417-304
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- B-cell Lymphoma-2 Inhibitor, Bruton Tyrosine Kinase Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Sonrotoclax plus Zanubrutinib | Experimental | Drug: Sonrotoclax, Drug: ZanubrutinibParticipants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation. |
| Arm B: Venetoclax plus Acalabrutinib | Active comparator | Drug: Acalabrutinib, Drug: VenetoclaxParticipants will receive venetoclax and acalabrutinib for a fixed duration followed by observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 bone marrow and organ function
Key exclusion criteria (6 listed)
- 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 or clinically significant cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonrotoclaxAlso: BGB-11417Administered orally. | Drug | Arm A: Sonrotoclax plus Zanubrutinib |
| ZanubrutinibAlso: BGB-3111, BrukinsaAdministered orally. | Drug | Arm A: Sonrotoclax plus Zanubrutinib |
| AcalabrutinibAlso: CalquenceAdministered orally. | Drug | Arm B: Venetoclax plus Acalabrutinib |
| VenetoclaxAlso: Venclexta, VenclyxtoAdministered orally. | Drug | Arm B: Venetoclax plus Acalabrutinib |
Primary outcome
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
Time frame: Up to approximately 70 months
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Time frame: Up to approximately 16 months
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
11 secondary outcomes
PFS in High-Risk Participants
Time frame: Up to approximately 70 months
Overall Survival (OS)
Time frame: Up to approximately 70 months
Overall Response Rate (ORR) as Determined by IRC
Time frame: Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Time frame: Up to approximately 16 months
Number of Participants with Adverse Events
Time frame: Up to approximately 70 months
PFS Determined by Investigator Assessment
Time frame: Up to approximately 70 months
Complete Response Rate (CRR) by IRC and Investigator Assessment
Time frame: Up to approximately 70 months
ORR Determined by Investigator Assessment
Time frame: Up to approximately 70 months
Duration of Response (DOR)
Time frame: Up to approximately 70 months
Time to Next Treatment (TTNT)
Time frame: Up to approximately 70 months
Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire
Time frame: At baseline and up to approximately 70 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
115 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sonrotoclax, Zanubrutinib and Acalabrutinib in people with Chronic Lymphocytic Leukemia, run by BeOne Medicines at 115 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, China, Australia, France, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (8778285568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) (time frame: Up to approximately 70 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.