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Active, not recruitingNCT03336333SEQUOIAUpdated Mar 9, 2026Results posted

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

A Phase 3 interventional study of Zanubrutinib and Bendamustine in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by BeiGene. Active, not recruiting at 158 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by BeiGene · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
590
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Keywords

  • zanubrutinib
  • BTK inhibitor
  • bendamustine
  • rituximab
  • venetoclax
  • BGB-3111
  • Phase 3
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
590 participants (actual)

Study arms

  • Experimental
    Cohort 1: Bendamustine + Rituximab

    Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)

    Drug: Bendamustine · Drug: Rituximab

  • Experimental
    Cohort 1: Zanubrutinib

    Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)

    Drug: Zanubrutinib

  • 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 · Drug: Rituximab

  • Experimental
    Cohort 1a (China only): Zanubrutinib

    Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)

    Drug: Zanubrutinib

  • Experimental
    Cohort 2: Zanubrutinib

    Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)

    Drug: Zanubrutinib

  • 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 · Drug: Venetoclax

Interventions

  • DrugZanubrutinib

    Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)

    Also known as: BGB-3111, BRUKINSA

  • DrugBendamustine

    Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.

    Also known as: Treanda, Ribomustin, and Levact

  • DrugRituximab

    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

    Also known as: Rituxan, MabThera

  • DrugVenetoclax

    400 mg tablets administered orally once daily.

    Also known as: Venclexta, Venclyxto

05

What researchers measure

Primary outcomes

  1. Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)

    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).

    Time frame: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)

Secondary outcomes

  1. Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR

    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.

    Time frame: Up to 5 years

  2. Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups

    Time frame: Up to 5 years

  3. Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR

    OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason.

    Time frame: Up to 5 years

  4. Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR

    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.

    Time frame: Up to 5 years

  5. Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups

    Time frame: Up to 5 years

  6. Cohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)

    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.

    Time frame: Up to 5 years

  7. Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)

    Time frame: Up to 5 years

  8. 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

  9. 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

  10. Cohort 2: Overall Response Rate (ORR)

    Time frame: Up to 5 years

  11. Cohort 2: Progression-free Survival (PFS)

    Time frame: Up to 5 years

  12. Cohort 2: Duration of Response (DOR)

    Time frame: Up to 5 years

  13. Cohort 3: Overall Response Rate (ORR)

    Time frame: Up to 5 years

  14. Cohort 3: Progression-free Survival (PFS)

    Time frame: Up to 5 years

  15. Cohort 3: Duration of Response (DOR)

    Time frame: Up to 5 years

  16. Cohort 3: Rate of Undetectable Minimal Residual Disease (MRD4)

    Time frame: Up to 5 years

  17. Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 5 years

  18. Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F

    Time frame: Predose up to 12 hours postdose

  19. 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

  20. Cohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib

    Time frame: Predose up to 12 hours postdose

06

Results

Posted Nov 7, 2023

Participant flow

Available data are presented as of the primary analysis data cut-off date of 07MAY2021; as of the data cut-off date, all cohorts were ongoing.

Participant flow — Overall Study
MilestoneCohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)
Started238241111
Treated227240111
Completed000
Not completed238241111
Withdrew: Remained on study at time of data cut-off202219102
Withdrew: Death14168
Withdrew: Withdrawal by subject1651
Withdrew: Physician decision510
Withdrew: Lost to follow-up100

Outcome measures

PrimaryCohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)

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).

Time frame:
Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)
Reported as:
Median · Months
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)
MonthsCohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)33.7 (28.1 to NA)NA (NA to NA)
Statistical analysis
  • Cohort 1: Bendamustine + Rituximab Without Del(17p) vs Cohort 1: Zanubrutinib Without Del(17p) · Log Rank · p = <0.0001 (One-sided) · Hazard ratio (hr): 0.42 · 95% CI 0.28 to 0.63
SecondaryCohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR

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.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryPooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR

OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR

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.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryPooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)

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.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryPooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 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

Results for this outcome have not been posted.

SecondaryCohort 2: Overall Response Rate (ORR)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 2: Progression-free Survival (PFS)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 2: Duration of Response (DOR)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 3: Overall Response Rate (ORR)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 3: Progression-free Survival (PFS)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 3: Duration of Response (DOR)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryCohort 3: Rate of Undetectable Minimal Residual Disease (MRD4)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryNumber of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame:
Up to 5 years

Results for this outcome have not been posted.

SecondaryApparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F
Time frame:
Predose up to 12 hours postdose

Results for this outcome have not been posted.

SecondaryCohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12)
Time frame:
Predose up to 12 hours postdose

Results for this outcome have not been posted.

SecondaryCohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib
Time frame:
Predose up to 12 hours postdose

Results for this outcome have not been posted.

SecondaryCohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib
Time frame:
Predose up to 12 hours postdose

Results for this outcome have not been posted.

Adverse events

Collected over All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: Bendamustine + Rituximab Without Del(17p)14/238 (5.9%)113/227 (49.8%)214/227 (94.3%)
Cohort 1: Zanubrutinib Without Del(17p)16/241 (6.6%)88/240 (36.7%)208/240 (86.7%)
Cohort 2: Zanubrutinib With Del(17p)8/111 (7.2%)45/111 (40.5%)104/111 (93.7%)
Most frequent serious events
Showing 10 of 232
Most frequent serious events
EventCohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)
PyrexiaGeneral disorders17/2272/2402/111
PneumoniaInfections and infestations7/2274/2406/111
Febrile neutropeniaBlood and lymphatic system disorders11/2271/2401/111
COVID-19Infections and infestations1/2278/2401/111
Infusion related reactionInjury, poisoning and procedural complications7/2270/2400/111
COVID-19 pneumoniaInfections and infestations0/2277/2401/111
Atrial fibrillationCardiac disorders1/2274/2403/111
FallInjury, poisoning and procedural complications2/2270/2403/111
SepsisInfections and infestations6/2272/2400/111
AnaemiaBlood and lymphatic system disorders5/2272/2401/111
Most frequent other events
Showing 10 of 85
Most frequent other events
EventCohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)
NeutropeniaBlood and lymphatic system disorders101/22730/24013/111
NauseaGastrointestinal disorders74/22724/24018/111
Upper respiratory tract infectionInfections and infestations27/22741/24023/111
PyrexiaGeneral disorders46/22715/2406/111
ContusionInjury, poisoning and procedural complications8/22746/24022/111
ArthralgiaMusculoskeletal and connective tissue disorders19/22732/24022/111
ConstipationGastrointestinal disorders43/22724/24017/111
RashSkin and subcutaneous tissue disorders42/22726/24016/111
AnaemiaBlood and lymphatic system disorders41/22711/2405/111
DiarrhoeaGastrointestinal disorders26/22733/24020/111

Baseline characteristics

Intent-to-treat analysis set included all enrolled participants who were assigned to a treatment group (as of cut-off date of 07MAY2021)

Age, Categorical
Age, Categorical(Participants)Cohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)Total
<=18 years0000
Between 18 and 65 years464516107
>=65 years19219695483
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)Total
Female948732213
Male14415479377
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)Total
Hispanic or Latino45110
Not Hispanic or Latino21121899528
Unknown or Not Reported23181152
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: Bendamustine + Rituximab Without Del(17p)Cohort 1: Zanubrutinib Without Del(17p)Cohort 2: Zanubrutinib With Del(17p)Total
American Indian or Alaska Native0000
Asian94114
Native Hawaiian or Other Pacific Islander0101
Black or African American1405
White206221105532
More than one race0000
Unknown or Not Reported2211538
07

Study locations

158 sites
  • Augusta University
    Augusta, Georgia 30912, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Research Medical Center
    Kansas City, Missouri 64132, United States
  • Washington University
    St Louis, Missouri 63110, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89169, United States
  • Summit Medical Group
    Florham Park, New Jersey 07932, United States
  • Icahn School of Medicine At Mount Sinai
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Prairie Lakes Healthcare System
    Watertown, South Dakota 57201, United States
  • Tennessee Oncology, Pllc Nashville
    Nashville, Tennessee 37203, United States
  • Joe Arrington Cancer Research and Treatment Center
    Lubbock, Texas 79410, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
  • Va Puget Sound Health Care System
    Seattle, Washington 98108, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
  • Concord Repatriation General Hospital
    Concord, New South Wales 2139, Australia
  • The Tweed Valley Hospital
    Cudgen, New South Wales 2487, Australia
  • Calvary Mater Newcastle
    Waratah, New South Wales 2298, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Icon Cancer Centre Wesley
    Auchenflower, Queensland 4066, Australia
  • Princess Alexandra Hospital
    Brisbane, Queensland 4102, Australia
  • Royal Brisbane and Womens Hospital
    Herston, Queensland 4029, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • The Queen Elizabeth Hospital
    Woodville South, South Australia 5011, Australia
  • Royal Hobart Hospital
    Hobart, Tasmania 7000, Australia
  • Box Hill Hospital
    Box Hill, Victoria 3128, Australia
  • Monash Health
    Clayton, Victoria 3168, Australia
  • St Vincents Hospital Melbourne
    Fitzroy, Victoria 3065, Australia
  • Peninsula Private Hospital
    Frankston, Victoria 3199, Australia
  • Peter Maccallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Royal Perth Hospital
    Perth, Western Australia 6000, Australia
  • Medizinische Universitatsklinik Innsbruck
    Innsbruck, 6020, Austria
  • Krankenhaus Der Barmherzigen Schwestern Linz
    Linz, 4010, Austria
  • Allgemeines Krankenhaus Der Stadt Linz
    Linz, 4021, Austria
  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
    Salzburg, 5020, Austria
  • Klinikum Wels Grieskirchen
    Wels, 4600, Austria
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
  • Universitair Ziekenhuis Gent
    Ghent, 9000, Belgium
  • Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
    Liège, 4000, Belgium
  • Clinique Saint Pierre
    Ottignies, 1340, Belgium
  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
    Yvoir, 5530, Belgium
  • Anhui Provincial Hospital
    Hefei, Anhui 230000, China
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100000, China
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality 100050, China
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
    Chongqing, Chongqing Municipality 400037, China
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
  • Quanzhou First Affliated Hospital of Fujian Medical University
    Quanzhou, Fujian 362000, China
  • Guangdong Provincial Peoples Hospital
    Guangzhou, Guangdong 510080, China
  • Henan Cancer Hospital
    Zhengzhou, Henan 450000, China
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
  • The First Affiliated Hospital of Soochow University Branch Shizi
    Suzhou, Jiangsu 215006, China
  • Wuxi Peoples Hospital
    Wuxi, Jiangsu 214023, China
  • The First Affiliated Hospital of Nanchang University Branch Donghu
    Nanchang, Jiangxi 330006, China
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
  • Institute of Hematology and Hospital of Blood Disease
    Tianjin, Tianjin Municipality 300020, China
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin Municipality 300060, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310003, China
  • Fakultni Nemocnice Brno
    Brno, 62500, Czechia
  • Fakultni Nemocnice Hradec Kralove
    Hradec Králové, 50005, Czechia
  • Fakultni Nemocnice Olomouc
    Olomouc, 77900, Czechia
  • Vseobecna Fakultni Nemocnice V Praze
    Prague, 10000, Czechia
  • Centre Hospitalier Victor Dupouy Dargenteuil
    Argenteuil, 95107, France
  • Centre de Lutte Contre Le Cancer Institut Bergonie
    Bordeaux, 33076, France
  • Chu Caen Normandie
    Caen, 14033, France
  • Centre Hospitalier Departemental de Vendee
    La Roche-sur-Yon, 85925, France
  • Centre Hospitalier Le Mans
    Le Mans, 72037, France
  • Centre Hospitalier Universitaire Limoges Chu de Limoges
    Limoges, 87042, France
  • Institut Paoli Calmettes
    Marseille, 13009, France
  • Centre Hospitalier Universitaire Nantes Hotel Dieu
    Nantes, 44093, France
  • Hopital de La Pitie Salpetriere
    Paris, 75013, France
  • Groupe Hospitalier Du Haut Leveque
    Pessac, 33604, France
  • Chu Hopital Lyon Sud
    PierreBenite, 69495, France
  • Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
    Poitiers, 86000, France
  • Hopital Robert Debre
    Reims, 51056, France
  • Hopital Pontchaillou
    Rennes, 35033, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Chu Tours Hopital Bretonneau Service Pneumologie
    Tours, 37000, France
  • Chu Nancy Hopital Brabois
    VandoeuvrelesNancy, 54511, France
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
    Brescia, 25123, Italy
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
    Meldola, 47014, Italy
  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
  • Ospedale San Raffaele
    Milan, 20132, Italy
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
    Milan, 20162, Italy
  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
    Modena, 41124, Italy
  • Azienda Unita Sanitaria Locale Di Ravenna
    Ravenna, 48121, Italy
  • Universita Degli Studi La Sapienza
    Roma, 00161, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli
    Roma, 00168, Italy
  • Azienda Ospedaliera S Maria Di Terni
    Terni, 05100, Italy
  • Ao Citta Della Salute E Della Scienza Di Torino Presidio O
    Torino, 10126, Italy
  • Auckland City Hospital
    Auckland, 1023, New Zealand
  • Christchurch Hospital
    Christchurch, 8011, New Zealand
  • Palmerston North Hospital
    Palmerston North, 4442, New Zealand
  • North Shore Hospital
    Takapuna, 0622, New Zealand
  • Tauranga Hospital
    Tauranga, 3112, New Zealand

Showing the first 100 of 158 sites across 15 countries.

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References and documents

Publications

  • Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26. PubMed 31875923 ↗
  • Tam CS, Robak T, Ghia P, Kahl BS, Walker P, Janowski W, Simpson D, Shadman M, Ganly PS, Laurenti L, Opat S, Tani M, Ciepluch H, Verner E, Simkovic M, Osterborg A, Trneny M, Tedeschi A, Paik JC, Kuwahara SB, Feng S, Ramakrishnan V, Cohen A, Huang J, Hillmen P, Brown JR. Zanubrutinib monotherapy for patients with treatment naive chronic lymphocytic leukemia and 17p deletion. Haematologica. 2021 Sep 1;106(9):2354-2363. doi: 10.3324/haematol.2020.259432. PubMed 33054121 ↗
  • Munir T, Martinez-Calle N, Xu S, Yang K, Ge X, Ali AK, Mohseninejad L, Dobi B, Rakonczai P, Ma H, Williams R, Aldairy W, Lamanna N. Indirect Comparisons of the Efficacy and Safety of Zanubrutinib versus Venetoclax plus Obinutuzumab in Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Oncol Ther. 2025 Dec;13(4):1055-1070. doi: 10.1007/s40487-025-00380-0. Epub 2025 Sep 13. PubMed 40944848 ↗
  • Shadman M, Munir T, Ma S, Lasica M, Tani M, Robak T, Flinn IW, Brown JR, Ghia P, Ferrant E, Tam CS, Janowski W, Jurczak W, Xu L, Tian T, Lefebure M, Agresti S, Hirata J, Tedeschi A. Zanubrutinib and Venetoclax for Patients With Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma With and Without Del(17p)/TP53 Mutation: SEQUOIA Arm D Results. J Clin Oncol. 2025 Jul 20;43(21):2409-2417. doi: 10.1200/JCO-25-00758. Epub 2025 May 31. PubMed 40448577 ↗
  • Shadman M, Munir T, Robak T, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Simkovic M, Osterborg A, Laurenti L, Walker PA, Opat SS, Ciepluch H, Greil R, Hanna M, Tani M, Trneny M, Brander D, Flinn IW, Grosicki S, Verner E, Tedeschi A, de Guibert S, Tumyan G, Laribi K, Garcia-Marco JA, Li JY, Tian T, Liu Y, Korolkiewicz R, Szeto A, Tam CS, Jurczak W. Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA. J Clin Oncol. 2025 Mar;43(7):780-787. doi: 10.1200/JCO-24-02265. Epub 2024 Dec 8. PubMed 39647999 ↗
  • Kittai AS, Allan JN, James D, Bridge H, Miranda M, Yong ASM, Fam F, Roos J, Shetty V, Skarbnik A, Davids MS. An indirect comparison of acalabrutinib with and without obinutuzumab vs zanubrutinib in treatment-naive CLL. Blood Adv. 2024 Jun 11;8(11):2861-2869. doi: 10.1182/bloodadvances.2023012142. PubMed 38598745 ↗
  • Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641. PubMed 38502198 ↗
  • Ghia P, Barnes G, Yang K, Tam CS, Robak T, Brown JR, Kahl BS, Tian T, Szeto A, Paik JC, Shadman M. Health-related quality-of-life in treatment-naive CLL/SLL patients treated with zanubrutinib versus bendamustine plus rituximab. Curr Med Res Opin. 2023 Nov;39(11):1505-1511. doi: 10.1080/03007995.2023.2262381. Epub 2023 Oct 12. PubMed 37752878 ↗
  • Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, Simkovic M, Shadman M, Osterborg A, Laurenti L, Walker P, Opat S, Chan H, Ciepluch H, Greil R, Tani M, Trneny M, Brander DM, Flinn IW, Grosicki S, Verner E, Tedeschi A, Li J, Tian T, Zhou L, Marimpietri C, Paik JC, Cohen A, Huang J, Robak T, Hillmen P. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5. Epub 2022 Jul 7. PubMed 35810754 ↗

Study documents

  • Study protocol · Feb 10, 2021
  • Statistical analysis plan · May 13, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT03336333
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Oct 31, 2017
Primary completion
May 7, 2021
Completion
Oct 31, 2027 (estimated)
Results posted
Nov 7, 2023
Last update
Mar 9, 2026

Study contacts

Study Director
study director · BeiGene

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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