Chronic Lymphocytic LeukemiaPhase 3SEQUOIANCT03336333
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
A Phase 3 study testing Zanubrutinib, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeiGene at 158 sites in 15 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Zanubrutinib, Bendamustine and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 158 sitesin 15 countries
- Study dates
- 31 Oct 2017to 31 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
158 sites in 15 countries.
158 sites in 15 countries
China19 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130021
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, 400037
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Anhui Provincial Hospital
Hefei, Anhui, 230000
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, 215006
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023
Henan Cancer Hospital
Zhengzhou, Henan, 450000
United States18 sites
Augusta University
Augusta, Georgia, 30912
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
Summit Medical Group
Florham Park, New Jersey, 07932
Research Medical Center
Kansas City, Missouri, 64132
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14642
Va Puget Sound Health Care System
Seattle, Washington, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
Prairie Lakes Healthcare System
Watertown, South Dakota, 57201
France17 sites
Centre Hospitalier Victor Dupouy Dargenteuil
Argenteuil, 95107
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
Chu Caen Normandie
Caen, 14033
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, 85925
Centre Hospitalier Le Mans
Le Mans, 72037
Centre Hospitalier Universitaire Limoges Chu de Limoges
Limoges, 87042
Institut Paoli Calmettes
Marseille, 13009
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44093
Hopital de La Pitie Salpetriere
Paris, 75013
Groupe Hospitalier Du Haut Leveque
Pessac, 33604
Chu Hopital Lyon Sud
PierreBenite, 69495
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
Poitiers, 86000
Hopital Robert Debre
Reims, 51056
Hopital Pontchaillou
Rennes, 35033
Centre Henri Becquerel
Rouen, 76038
Chu Tours Hopital Bretonneau Service Pneumologie
Tours, 37000
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511
Australia16 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Box Hill Hospital
Box Hill, Victoria, 3128
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Monash Health
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
The Tweed Valley Hospital
Cudgen, New South Wales, 2487
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Peninsula Private Hospital
Frankston, Victoria, 3199
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Royal Perth Hospital
Perth, Western Australia, 6000
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Westmead Hospital
Westmead, New South Wales, 2145
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
United Kingdom16 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ
Kent and Canterbury Hospital
Canterbury, CT1 3NG
The Christie Hospital
Greater Manchester, M20 4BX
The Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF
Barts and the London Nhs Trust
London, EC1M 6BQ
Royal Marsden Hospital
London, SW3 6JJ
Sarah Cannon Research Institute Uk
London, W1G 6AD
Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital
Maidstone, ME16 9QQ
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY
Nottingham University Hospitals Nhs Trust
Nottingham, NG51PB
Derriford Hospital
Plymouth, PL6 8DH
Southampton General Hospital
Southampton, SO16 6YD
Sunderland Royal Hospital
Sunderland, SR4 7TP
The Royal Wolverhampton Nhs Trust
Wolverhampton, WV10 0QP
Russia15 sites
Kaluga Regional Hospital
Kaluga, Kaluga Oblast, 248000
Clinical Oncology Dispensary
Kazan, Tambov Oblast, 420029
Kemerovo Regional Clinical Hospital Na Sv Belyaev
Kemerovo, Pskov Oblast, 650066
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, 115478
Russian Academy of Advanced Medical Studies, City Clinical Hospital
Moscow, Moscow, 115478
Nizhniy Novgorod Regional Clinical Hospital Nasemashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
State Budgetary Healthcare Institution Regional Clinical Dispensary
Penza, Penza Oblast, 440071
State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment
Perm, Permskiy Kray, 614077
Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, 390039
Fgu Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Sankt-Peterburg, 191024
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, 354057
Tula Area Clinical Hospital
Tula, Tula Oblast, 300053
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, 400138
Sverdlovsk Regional Clinical Hospital
Yekaterinburg, Sverdlovsk Oblast, 620102
Central City Hospital
Yekaterinburg, Sverdlovsk Oblast, 620137
Italy11 sites
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Ospedale San Raffaele
Milan, 20132
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, 41124
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna, 48121
Universita Degli Studi La Sapienza
Roma, 00161
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda Ospedaliera S Maria Di Terni
Terni, 05100
Ao Citta Della Salute E Della Scienza Di Torino Presidio O
Torino, 10126
Poland9 sites
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, 41-500
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk, 80-219
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519
Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach
Gliwice, 44-101
Malopolskie Centrum Medyczne Sc
Krakow, 30-510
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica, 59-220
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090
Spain9 sites
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital Del Mar
Barcelona, 08003
Institut Catala Doncologia
Barcelona, 08908
Hospital de La Princesa
Madrid, 28006
Clinica Universidad de Navarra
Madrid, 28027
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Clinica Universidad de Navarra Pamplona
Pamplona, 31008
Hospital Universitari I Politecnic La Fe
Valencia, 46026
Hospital de Dia Quironsalud Zaragoza
Zaragoza, 50009
Sweden6 sites
Medicinkliniken
Borås, 501 82
Sahlgrenska Universitetssjukhuset
Gothenburg, 416 85
Skanes Universitetssjukhus I Lund
Lund, 221 85
Universitetssjukhuset Orebro
Örebro, 701 85
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Uppsala Akademiska Sjukhus
Uppsala, 75185
Austria5 sites
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 4010
Allgemeines Krankenhaus Der Stadt Linz
Linz, 4021
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, 5020
Klinikum Wels Grieskirchen
Wels, 4600
Belgium5 sites
Universitair Ziekenhuis Brussel
Brussels, 1090
Universitair Ziekenhuis Gent
Ghent, 9000
Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
Liège, 4000
Clinique Saint Pierre
Ottignies, 1340
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir, 5530
New Zealand5 sites
Auckland City Hospital
Auckland, 1023
Christchurch Hospital
Christchurch, 8011
Palmerston North Hospital
Palmerston North, 4442
North Shore Hospital
Takapuna, 0622
Tauranga Hospital
Tauranga, 3112
Czechia4 sites
Fakultni Nemocnice Brno
Brno, 62500
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 50005
Fakultni Nemocnice Olomouc
Olomouc, 77900
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
Taiwan3 sites
Hualien Tzu Chi Hospital
Hualien City, 970
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
National Taiwan University Hospital East Campus
Taipei, 100225
About this study
Official title: 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.
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.
- Being tested
- Zanubrutinib, Bendamustine, Rituximab, Venetoclax
- Keywords
- zanubrutinib, BTK inhibitor, bendamustine, rituximab, venetoclax, BGB-3111, Phase 3
- 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.
ZanubrutinibDrug
Also called BGB-3111, BRUKINSA
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
BendamustineDrug
Also called Treanda, Ribomustin, and Levact
Administered intravenously (IV) at a dose of 90 mg/m^2/day on the first 2 days of each cycle for 6 cycles.
RituximabDrug
Also called Rituxan, MabThera
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
VenetoclaxDrug
Also called Venclexta, Venclyxto
400 mg tablets administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Bendamustine + Rituximab | Experimental | Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B) Receives: Drug: Bendamustine; Drug: Rituximab |
| Cohort 1: Zanubrutinib | Experimental | Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A) Receives: Drug: Zanubrutinib |
| Cohort 1a (China only): Bendamustine + Rituximab | Experimental | Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only) Receives: Drug: Bendamustine; Drug: Rituximab |
| Cohort 1a (China only): Zanubrutinib | Experimental | Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only) Receives: Drug: Zanubrutinib |
| Cohort 2: Zanubrutinib | Experimental | Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C) Receives: Drug: Zanubrutinib |
| Cohort 3: Venetoclax + Zanubrutinib | Experimental | 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) Receives: Drug: Zanubrutinib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)
Secondary outcomes (20)
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.
Measured: Up to 5 years
Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups
Measured: Up to 5 years
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.
Measured: Up to 5 years
Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA)
Measured: Up to 5 years
Cohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire
Measured: 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.
Measured: Up to 5 years
Cohort 2: Overall Response Rate (ORR)
Measured: Up to 5 years
Cohort 2: Progression-free Survival (PFS)
Measured: Up to 5 years
Cohort 2: Duration of Response (DOR)
Measured: Up to 5 years
Cohort 3: Overall Response Rate (ORR)
Measured: Up to 5 years
Cohort 3: Progression-free Survival (PFS)
Measured: Up to 5 years
Cohort 3: Duration of Response (DOR)
Measured: Up to 5 years
Cohort 3: Rate of Undetectable Minimal Residual Disease (MRD4)
Measured: Up to 5 years
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 5 years
Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F
Measured: Predose up to 12 hours postdose
Cohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12)
Measured: Predose up to 12 hours postdose
Cohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib
Measured: Predose up to 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start31 Oct 2017
- Primary completion7 May 2021
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe 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
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336333
- Sponsor's protocol ID
- BGB-3111-304
- Other IDs
- 2017-001551-31, CTR20190416, 2017
- Acronym
- SEQUOIA
- Status last verified
- Feb 2026
- First submitted
- 1 Nov 2017
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 31875923Tam 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 33054121Munir 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 40944848Shadman 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 40448577Shadman 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 39647999Kittai 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.
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