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

NCT ID: NCT03336333

Last Updated: 2025-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: Bendamustine + Rituximab

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

Group Type EXPERIMENTAL

Bendamustine

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

Cohort 1: Zanubrutinib

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

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

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

Cohort 1a (China only): Bendamustine + Rituximab

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

Group Type EXPERIMENTAL

Bendamustine

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

Cohort 1a (China only): Zanubrutinib

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

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

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

Cohort 2: Zanubrutinib

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

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

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

Venetoclax

Intervention Type DRUG

400 mg tablets administered orally once daily.

Interventions

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Zanubrutinib

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

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Venetoclax

400 mg tablets administered orally once daily.

Intervention Type DRUG

Other Intervention Names

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BGB-3111 BRUKINSA Treanda, Ribomustin, and Levact Rituxan, MabThera Venclexta, Venclyxto

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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Augusta University

Augusta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Summit Medical Group

Florham Park, New Jersey, United States

Site Status

Icahn School of Medicine At Mount Sinai

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Prairie Lakes Healthcare System

Watertown, South Dakota, United States

Site Status

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Va Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status

The Tweed Valley Hospital

Cudgen, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Site Status

Peninsula Private Hospital

Frankston, Victoria, Australia

Site Status

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Medizinische Universitatsklinik Innsbruck

Innsbruck, , Austria

Site Status

Krankenhaus Der Barmherzigen Schwestern Linz

Linz, , Austria

Site Status

Allgemeines Krankenhaus Der Stadt Linz

Linz, , Austria

Site Status

Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status

Klinikum Wels Grieskirchen

Wels, , Austria

Site Status

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman

Liège, , Belgium

Site Status

Clinique Saint Pierre

Ottignies, , Belgium

Site Status

Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

Yvoir, , Belgium

Site Status

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, Chongqing Municipality, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Quanzhou First Affliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Site Status

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

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Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University Branch Shizi

Suzhou, Jiangsu, China

Site Status

Wuxi Peoples Hospital

Wuxi, Jiangsu, China

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The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Fakultni Nemocnice Brno

Brno, , Czechia

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Fakultni Nemocnice Hradec Kralove

Hradec Králové, , Czechia

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Fakultni Nemocnice Olomouc

Olomouc, , Czechia

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Vseobecna Fakultni Nemocnice V Praze

Prague, , Czechia

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Centre Hospitalier Victor Dupouy Dargenteuil

Argenteuil, , France

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Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, , France

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Chu Caen Normandie

Caen, , France

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Centre Hospitalier Departemental de Vendee

La Roche-sur-Yon, , France

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Centre Hospitalier Le Mans

Le Mans, , France

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Centre Hospitalier Universitaire Limoges Chu de Limoges

Limoges, , France

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Institut Paoli Calmettes

Marseille, , France

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Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, , France

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Hopital de La Pitie Salpetriere

Paris, , France

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Groupe Hospitalier Du Haut Leveque

Pessac, , France

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Chu Hopital Lyon Sud

PierreBenite, , France

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Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard

Poitiers, , France

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Hopital Robert Debre

Reims, , France

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Hopital Pontchaillou

Rennes, , France

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Centre Henri Becquerel

Rouen, , France

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Chu Tours Hopital Bretonneau Service Pneumologie

Tours, , France

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Chu Nancy Hopital Brabois

VandoeuvrelesNancy, , France

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Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, , Italy

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Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, , Italy

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Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

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Ospedale San Raffaele

Milan, , Italy

Site Status

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, , Italy

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Azienda Unita Sanitaria Locale Di Ravenna

Ravenna, , Italy

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Universita Degli Studi La Sapienza

Roma, , Italy

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Fondazione Policlinico Universitario Agostino Gemelli

Roma, , Italy

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Azienda Ospedaliera S Maria Di Terni

Terni, , Italy

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Ao Citta Della Salute E Della Scienza Di Torino Presidio O

Torino, , Italy

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Auckland City Hospital

Auckland, , New Zealand

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Christchurch Hospital

Christchurch, , New Zealand

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Palmerston North Hospital

Palmerston North, , New Zealand

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North Shore Hospital

Takapuna, , New Zealand

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Tauranga Hospital

Tauranga, , New Zealand

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Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

Brzozów, , Poland

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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, , Poland

Site Status

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

Gdansk, , Poland

Site Status

Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

Gdynia, , Poland

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Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach

Gliwice, , Poland

Site Status

Malopolskie Centrum Medyczne Sc

Krakow, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny W Legnicy

Legnica, , Poland

Site Status

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, , Poland

Site Status

Centrum Onkologii Ziemi Lubelskiej

Lublin, , Poland

Site Status

Kaluga Regional Hospital

Kaluga, Kaluga Oblast, Russia

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State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region

Sochi, Krasnodarskiy Kray, Russia

Site Status

N N Blokhin Russian Cancer Research Center Konstantin Laktionov

Moscow, Moscow, Russia

Site Status

Russian Academy of Advanced Medical Studies, City Clinical Hospital

Moscow, Moscow, Russia

Site Status

Nizhniy Novgorod Regional Clinical Hospital Nasemashko

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Site Status

State Budgetary Healthcare Institution Regional Clinical Dispensary

Penza, Penza Oblast, Russia

Site Status

State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment

Perm, Permskiy Kray, Russia

Site Status

Kemerovo Regional Clinical Hospital Na Sv Belyaev

Kemerovo, Pskov Oblast, Russia

Site Status

Ryazan Regional Clinical Hospital

Ryazan, Ryazan Oblast, Russia

Site Status

Fgu Russian Scientific Research Institute of Hematology and Transfusiology

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Sverdlovsk Regional Clinical Hospital

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Central City Hospital

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Clinical Oncology Dispensary

Kazan, Tambov Oblast, Russia

Site Status

Tula Area Clinical Hospital

Tula, Tula Oblast, Russia

Site Status

State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary

Volgograd, Volgograd Oblast, Russia

Site Status

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Site Status

Hospital Del Mar

Barcelona, , Spain

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Institut Catala Doncologia

Barcelona, , Spain

Site Status

Hospital de La Princesa

Madrid, , Spain

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Clinica Universidad de Navarra

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status

Clinica Universidad de Navarra Pamplona

Pamplona, , Spain

Site Status

Hospital Universitari I Politecnic La Fe

Valencia, , Spain

Site Status

Hospital de Dia Quironsalud Zaragoza

Zaragoza, , Spain

Site Status

Medicinkliniken

Borås, , Sweden

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Skanes Universitetssjukhus I Lund

Lund, , Sweden

Site Status

Universitetssjukhuset Orebro

Örebro, , Sweden

Site Status

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Site Status

Uppsala Akademiska Sjukhus

Uppsala, , Sweden

Site Status

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

National Taiwan University Hospital East Campus

Taipei, , Taiwan

Site Status

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth, , United Kingdom

Site Status

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, , United Kingdom

Site Status

Kent and Canterbury Hospital

Canterbury, , United Kingdom

Site Status

The Christie Hospital

Greater Manchester, , United Kingdom

Site Status

The Leeds Teaching Hospitals Nhs Trust

Leeds, , United Kingdom

Site Status

Barts and the London Nhs Trust

London, , United Kingdom

Site Status

Royal Marsden Hospital

London, , United Kingdom

Site Status

Sarah Cannon Research Institute Uk

London, , United Kingdom

Site Status

Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital

Maidstone, , United Kingdom

Site Status

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich, , United Kingdom

Site Status

Nottingham University Hospitals Nhs Trust

Nottingham, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Sunderland Royal Hospital

Sunderland, , United Kingdom

Site Status

The Royal Wolverhampton Nhs Trust

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium China Czechia France Italy New Zealand Poland Russia Spain Sweden Taiwan United Kingdom

References

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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.

Reference Type RESULT
PMID: 31875923 (View on PubMed)

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.

Reference Type RESULT
PMID: 33054121 (View on PubMed)

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 Sep 13. doi: 10.1007/s40487-025-00380-0. Online ahead of print.

Reference Type DERIVED
PMID: 40944848 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40448577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39647999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38598745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38502198 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37752878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35810754 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-001551-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTR20190416

Identifier Type: REGISTRY

Identifier Source: secondary_id

BGB-3111-304

Identifier Type: -

Identifier Source: org_study_id

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