A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL (SEQUOIA)

February 17, 2026 updated by: BeiGene

An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in participants with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3]. Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Participants in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax.

Study Type

Interventional

Enrollment (Actual)

590

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, 2139
        • Concord Repatriation General Hospital
      • Cudgen, New South Wales, Australia, 2487
        • The Tweed Valley Hospital
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Centre Wesley
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Womens Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitatsklinik Innsbruck
      • Linz, Austria, 4010
        • Krankenhaus Der Barmherzigen Schwestern Linz
      • Linz, Austria, 4021
        • Allgemeines Krankenhaus der Stadt Linz
      • Salzburg, Austria, 5020
        • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
      • Wels, Austria, 4600
        • Klinikum Wels Grieskirchen
  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
      • Yvoir, Belgium, 5530
        • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100000
        • Peking University Third Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Affliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University Branch Shizi
      • Wuxi, Jiangsu, China, 214023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • 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
  • Czechia
      • Brno, Czechia, 62500
        • Fakultní nemocnice Brno
      • Hradec Králové, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 10000
        • Vseobecna fakultni nemocnice v Praze
  • France
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy Dargenteuil
      • Bordeaux, France, 33076
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • Caen, France, 14033
        • CHU Caen Normandie
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Départemental de Vendée
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Limoges Chu de Limoges
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Paris, France, 75013
        • Hôpital de la Pitié Salpêtrière
      • Pessac, France, 33604
        • Groupe Hospitalier Du Haut Leveque
      • PierreBenite, France, 69495
        • Chu Hopital Lyon Sud
      • Poitiers, France, 86000
        • Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
      • Reims, France, 51056
        • Hopital Robert Debre
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Tours, France, 37000
        • Chu Tours Hopital Bretonneau Service Pneumologie
      • VandoeuvrelesNancy, France, 54511
        • Chu Nancy Hopital Brabois
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Meldola, Italy, 47014
        • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Modena, Italy, 41124
        • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
      • Ravenna, Italy, 48121
        • Azienda Unita Sanitaria Locale Di Ravenna
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00161
        • Universita Degli Studi La Sapienza
      • Terni, Italy, 05100
        • Azienda Ospedaliera S Maria Di Terni
      • Torino, Italy, 10126
        • Ao Citta Della Salute E Della Scienza Di Torino Presidio O
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Palmerston North, New Zealand, 4442
        • Palmerston North Hospital
      • Takapuna, New Zealand, 0622
        • North Shore Hospital
      • Tauranga, New Zealand, 3112
        • Tauranga Hospital
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
      • Chorzów, Poland, 41-500
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Gdansk, Poland, 80-219
        • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
      • Gliwice, Poland, 44-101
        • Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne Sc
      • Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny w Legnicy
      • Lodz, Poland, 93-510
        • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
  • Russia
    • Kaluga Oblast
      • Kaluga, Kaluga Oblast, Russia, 248000
        • Kaluga Regional Hospital
    • Krasnodarskiy Kray
      • Sochi, Krasnodarskiy Kray, Russia, 354057
        • State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • N N Blokhin Russian Cancer Research Center Konstantin Laktionov
      • Moscow, Moscow, Russia, 115478
        • Russian Academy of Advanced Medical Studies, City Clinical Hospital
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhniy Novgorod Regional Clinical Hospital Nasemashko
    • Penza Oblast
      • Penza, Penza Oblast, Russia, 440071
        • State Budgetary Healthcare Institution Regional Clinical Dispensary
    • Permskiy Kray
      • Perm, Permskiy Kray, Russia, 614077
        • State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment
    • Pskov Oblast
      • Kemerovo, Pskov Oblast, Russia, 650066
        • Kemerovo Regional Clinical Hospital Na Sv Belyaev
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russia, 390039
        • Ryazan Regional Clinical Hospital
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 191024
        • Fgu Russian Scientific Research Institute of Hematology and Transfusiology
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620137
        • Central City Hospital
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620102
        • Sverdlovsk Regional Clinical Hospital
    • Tambov Oblast
      • Kazan, Tambov Oblast, Russia, 420029
        • Clinical Oncology Dispensary
    • Tula Oblast
      • Tula, Tula Oblast, Russia, 300053
        • Tula Area Clinical Hospital
    • Volgograd Oblast
      • Volgograd, Volgograd Oblast, Russia, 400138
        • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra Pamplona
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
      • Zaragoza, Spain, 50009
        • Hospital de Día Quirónsalud Zaragoza
  • Sweden
      • Borås, Sweden, 501 82
        • Medicinkliniken
      • Gothenburg, Sweden, 416 85
        • Sahlgrenska Universitetssjukhuset
      • Lund, Sweden, 221 85
        • Skanes Universitetssjukhus I Lund
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna
      • Uppsala, Sweden, 75185
        • Uppsala Akademiska Sjukhus
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Örebro
  • Taiwan
      • Hualien City, Taiwan, 970
        • Hualien Tzu Chi Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital East Campus
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • Leeds, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals Nhs Trust
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, United Kingdom, EC1M 6BQ
        • Barts and the London NHS Trust
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG51PB
        • Nottingham University Hospitals NHS Trust
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust
  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Prairie Lakes Healthcare System
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, Pllc Nashville
    • Texas
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
  • Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
  • Measurable disease by imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Life expectancy ≥ 6 months
  • Adequate bone marrow function
  • Adequate renal and hepatic function

Key Exclusion Criteria:

  • Previous systemic treatment for CLL/SLL
  • Requires ongoing need for corticosteroid treatment
  • Known prolymphocytic leukemia or history of or suspected Richter's transformation.
  • Clinically significant cardiovascular disease
  • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer
  • History of severe bleeding disorder
  • History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
  • Severe or debilitating pulmonary disease
  • Inability to swallow capsules or disease affecting gastrointestinal function
  • Active infection requiring systemic treatment
  • Known central nervous system involvement by leukemia or lymphoma
  • Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs
  • Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection
  • Major surgery ≤ 4 weeks prior to start of study treatment
  • Pregnant or nursing females
  • Vaccination with live vaccine within 35 days prior to the first dose of study drug.
  • Ongoing alcohol or drug addiction
  • Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs
  • Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer
  • Concurrent participation in another therapeutic clinical study

NOTE: Other protocol defined Inclusion/Exclusion 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: Cohort 1: Bendamustine + Rituximab
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)
Drug: Bendamustine
Administered intravenously (IV) at a dose of 90 mg/m^2/day on the first 2 days of each cycle for 6 cycles.
Other Names:
  • Treanda, Ribomustin, and Levact
Drug: Rituximab
Administered intravenously (IV) at a dose of 375 mg/m^2 on day 0 of cycle 1, and at a dose of 500 mg/m^2 on day 1 of cycles 2 to 6
Other Names:
  • Rituxan, MabThera
Experimental: Cohort 1: Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)
Drug: Zanubrutinib
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Other Names:
  • BGB-3111
  • BRUKINSA
Experimental: Cohort 1a (China only): Bendamustine + Rituximab
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)
Drug: Bendamustine
Administered intravenously (IV) at a dose of 90 mg/m^2/day on the first 2 days of each cycle for 6 cycles.
Other Names:
  • Treanda, Ribomustin, and Levact
Drug: Rituximab
Administered intravenously (IV) at a dose of 375 mg/m^2 on day 0 of cycle 1, and at a dose of 500 mg/m^2 on day 1 of cycles 2 to 6
Other Names:
  • Rituxan, MabThera
Experimental: Cohort 1a (China only): Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)
Drug: Zanubrutinib
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Other Names:
  • BGB-3111
  • BRUKINSA
Experimental: Cohort 2: Zanubrutinib
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)
Drug: Zanubrutinib
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Other Names:
  • BGB-3111
  • BRUKINSA
Experimental: Cohort 3: Venetoclax + Zanubrutinib
Approximately 110 participants, 50 without del17p and 60 with del[17p] or TP53 mutation will receive zanubrutinib plus venetoclax; Participants will also receive zanubrutinib starting on Cycle 1 Day 1 then daily for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Participants will receive venetoclax starting Cycle 4 Day 1 according to a 5-week dose-up schedule then daily until unacceptable toxicity, disease progression, or for a maximum of 24 cycles. Each cycle is 28 days. (Arm D)
Drug: Zanubrutinib
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Other Names:
  • BGB-3111
  • BRUKINSA
Drug: Venetoclax
400 mg tablets administered orally once daily.
Other Names:
  • Venclexta, Venclyxto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)
Time Frame: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).
Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR
Time Frame: Up to 5 years
ORR in Cohort 1 is defined as the percentage of participants who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by the ICR.
Up to 5 years
Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups
Time Frame: Up to 5 years
Up to 5 years
Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR
Time Frame: Up to 5 years
OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason.
Up to 5 years
Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR
Time Frame: Up to 5 years
Duration of response in Cohort 1 determined using the iwCLL criteria with modification for treatment related lymphocytosis (in participants with CLL) and the Lugano Classification for non-Hodgkin lymphoma (NHL; in participants with SLL), is defined as the time from the date that criteria for response (ie, partial response with lymphocytosis [PR-L] or better) are first met to the date that disease progression is objectively documented or death, whichever occurs first.
Up to 5 years
Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups
Time Frame: Up to 5 years
Up to 5 years
Cohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)
Time Frame: Up to 5 years
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per iwCLL guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL.
Up to 5 years
Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)
Time Frame: Up to 5 years
Up to 5 years
Cohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire
Time Frame: Up to 5 years
Up to 5 years
Cohort 1: Patient-reported Outcomes as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire.
Time Frame: Up to 5 years
Up to 5 years
Cohort 2: Overall Response Rate (ORR)
Time Frame: Up to 5 years
Up to 5 years
Cohort 2: Progression-free Survival (PFS)
Time Frame: Up to 5 years
Up to 5 years
Cohort 2: Duration of Response (DOR)
Time Frame: Up to 5 years
Up to 5 years
Cohort 3: Overall Response Rate (ORR)
Time Frame: Up to 5 years
Up to 5 years
Cohort 3: Progression-free Survival (PFS)
Time Frame: Up to 5 years
Up to 5 years
Cohort 3: Duration of Response (DOR)
Time Frame: Up to 5 years
Up to 5 years
Cohort 3: Rate of Undetectable Minimal Residual Disease (MRD4)
Time Frame: Up to 5 years
Up to 5 years
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 5 years
Up to 5 years
Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F
Time Frame: Predose up to 12 hours postdose
Predose up to 12 hours postdose
Cohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12)
Time Frame: Predose up to 12 hours postdose
Predose up to 12 hours postdose
Cohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib
Time Frame: Predose up to 12 hours postdose
Predose up to 12 hours postdose

Collaborators and Investigators

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

Sponsor

BeiGene

Investigators

  • Study Director: Study Director, BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 31, 2017

Primary Completion (Actual)

May 7, 2021

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-304
  • 2017-001551-31 (EudraCT Number)
  • CTR20190416 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeiGene 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.

BeiGene 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 BeiGene 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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