A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
SEQUOIA
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)
3 other identifiers
interventional
590
14 countries
153
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2017
Longer than P75 for phase_3
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2017
CompletedFirst Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2021
CompletedResults Posted
Study results publicly available
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
ExpectedMarch 9, 2026
February 1, 2026
3.5 years
November 1, 2017
October 16, 2023
February 17, 2026
Conditions
Keywords
Outcome Measures
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).
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
Up to 5 years
Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups
Up to 5 years
Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR
Up to 5 years
Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR
Up to 5 years
Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups
Up to 5 years
- +15 more secondary outcomes
Study Arms (6)
Cohort 1: Bendamustine + Rituximab
EXPERIMENTALParticipants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)
Cohort 1: Zanubrutinib
EXPERIMENTALParticipants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)
Cohort 1a (China only): Bendamustine + Rituximab
EXPERIMENTALParticipants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)
Cohort 1a (China only): Zanubrutinib
EXPERIMENTALParticipants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)
Cohort 2: Zanubrutinib
EXPERIMENTALParticipants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)
Cohort 3: Venetoclax + Zanubrutinib
EXPERIMENTALApproximately 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)
Interventions
400 mg tablets administered orally once daily.
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (158)
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 KrĂ¡lovĂ©, 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
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
BrzozĂ³w, 36-200, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
ChorzĂ³w, 41-500, Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519, Poland
Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach
Gliwice, 44-101, Poland
Malopolskie Centrum Medyczne Sc
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica, 59-220, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Kaluga Regional Hospital
Kaluga, Kaluga Oblast, 248000, Russia
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, 354057, Russia
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, 115478, Russia
Russian Academy of Advanced Medical Studies, City Clinical Hospital
Moscow, Moscow, 115478, Russia
Nizhniy Novgorod Regional Clinical Hospital Nasemashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
State Budgetary Healthcare Institution Regional Clinical Dispensary
Penza, Penza Oblast, 440071, Russia
State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment
Perm, Permskiy Kray, 614077, Russia
Kemerovo Regional Clinical Hospital Na Sv Belyaev
Kemerovo, Pskov Oblast, 650066, Russia
Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, 390039, Russia
Fgu Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Sankt-Peterburg, 191024, Russia
Sverdlovsk Regional Clinical Hospital
Yekaterinburg, Sverdlovsk Oblast, 620102, Russia
Central City Hospital
Yekaterinburg, Sverdlovsk Oblast, 620137, Russia
Clinical Oncology Dispensary
Kazan, Tambov Oblast, 420029, Russia
Tula Area Clinical Hospital
Tula, Tula Oblast, 300053, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, 400138, Russia
Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Institut Catala Doncologia
Barcelona, 08908, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Clinica Universidad de Navarra Pamplona
Pamplona, 31008, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Hospital de Dia Quironsalud Zaragoza
Zaragoza, 50009, Spain
Medicinkliniken
BorĂ¥s, 501 82, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 416 85, Sweden
Skanes Universitetssjukhus I Lund
Lund, 221 85, Sweden
Universitetssjukhuset Orebro
Ă–rebro, 701 85, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Uppsala Akademiska Sjukhus
Uppsala, 75185, Sweden
Hualien Tzu Chi Hospital
Hualien City, 970, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Taiwan University Hospital East Campus
Taipei, 100225, Taiwan
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW, United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
The Christie Hospital
Greater Manchester, M20 4BX, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF, United Kingdom
Barts and the London Nhs Trust
London, EC1M 6BQ, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Sarah Cannon Research Institute Uk
London, W1G 6AD, United Kingdom
Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, NG51PB, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Sunderland Royal Hospital
Sunderland, SR4 7TP, United Kingdom
The Royal Wolverhampton Nhs Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (9)
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.
PMID: 31875923RESULTTam 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.
PMID: 33054121RESULTMunir 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.
PMID: 40944848DERIVEDShadman 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.
PMID: 40448577DERIVEDShadman 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.
PMID: 39647999DERIVEDKittai 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.
PMID: 38598745DERIVEDMoslehi 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.
PMID: 38502198DERIVEDGhia 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.
PMID: 37752878DERIVEDTam 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.
PMID: 35810754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2017
First Posted
November 8, 2017
Study Start
October 31, 2017
Primary Completion
May 7, 2021
Study Completion (Estimated)
October 31, 2027
Last Updated
March 9, 2026
Results First Posted
November 7, 2023
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See 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.