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New pill could outshine chemo for common blood cancer

NCT ID NCT03336333

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the targeted drug zanubrutinib works better than the standard chemo combination of bendamustine plus rituximab for people with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). About 590 participants who cannot tolerate stronger chemo will be randomly assigned to one of the two treatments. The main goal is to see if zanubrutinib keeps the cancer from growing longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zanubrutinib (a targeted cancer pill)
What this could lead to
If successful, this could offer a more effective and possibly gentler first-line treatment option for people with chronic lymphocytic leukemia or small lymphocytic lymphoma.
What could go wrong
This is an active but not yet recruiting trial, so results are pending. Zanubrutinib may not prove superior to standard therapy, and side effects like bleeding or heart rhythm issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

590 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • Allgemeines Krankenhaus Der Stadt Linz

    Linz, 4021, Austria

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Ao Citta Della Salute E Della Scienza Di Torino Presidio O

    Torino, 10126, Italy

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera S Maria Di Terni

    Terni, 05100, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Unita Sanitaria Locale Di Ravenna

    Ravenna, 48121, Italy

  • Barts and the London Nhs Trust

    London, EC1M 6BQ, United Kingdom

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Central City Hospital

    Yekaterinburg, Sverdlovsk Oblast, 620137, Russia

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

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

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire Limoges Chu de Limoges

    Limoges, 87042, France

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44093, France

  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

    Yvoir, 5530, Belgium

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

    Poitiers, 86000, France

  • Centre Hospitalier Victor Dupouy Dargenteuil

    Argenteuil, 95107, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076, France

  • Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach

    Gliwice, 44-101, Poland

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090, Poland

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Chu Caen Normandie

    Caen, 14033, France

  • Chu Hopital Lyon Sud

    PierreBenite, 69495, France

  • Chu Nancy Hopital Brabois

    VandoeuvrelesNancy, 54511, France

  • Chu Tours Hopital Bretonneau Service Pneumologie

    Tours, 37000, France

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra Pamplona

    Pamplona, 31008, Spain

  • Clinical Oncology Dispensary

    Kazan, Tambov Oblast, 420029, Russia

  • Clinique Saint Pierre

    Ottignies, 1340, Belgium

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdansk, 80-219, Poland

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Duke University

    Durham, North Carolina, 27710, United States

  • Fakultni Nemocnice Brno

    Brno, 62500, Czechia

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Fgu Russian Scientific Research Institute of Hematology and Transfusiology

    Saint Petersburg, Sankt-Peterburg, 191024, Russia

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Groupe Hospitalier Du Haut Leveque

    Pessac, 33604, France

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hopital Pontchaillou

    Rennes, 35033, France

  • Hopital Robert Debre

    Reims, 51056, France

  • Hopital de La Pitie Salpetriere

    Paris, 75013, France

  • Hospital Del Mar

    Barcelona, 08003, Spain

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital de Dia Quironsalud Zaragoza

    Zaragoza, 50009, Spain

  • Hospital de La Princesa

    Madrid, 28006, Spain

  • Hualien Tzu Chi Hospital

    Hualien City, 970, Taiwan

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029, United States

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066, Australia

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014, Italy

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410, United States

  • Kaluga Regional Hospital

    Kaluga, Kaluga Oblast, 248000, Russia

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76, Sweden

  • Kemerovo Regional Clinical Hospital Na Sv Belyaev

    Kemerovo, Pskov Oblast, 650066, Russia

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Klinikum Wels Grieskirchen

    Wels, 4600, Austria

  • Krankenhaus Der Barmherzigen Schwestern Linz

    Linz, 4010, Austria

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

    Maidstone, ME16 9QQ, United Kingdom

  • Malopolskie Centrum Medyczne Sc

    Krakow, 30-510, Poland

  • Medicinkliniken

    Borås, 501 82, Sweden

  • Medizinische Universitatsklinik Innsbruck

    Innsbruck, 6020, Austria

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • N N Blokhin Russian Cancer Research Center Konstantin Laktionov

    Moscow, Moscow, 115478, Russia

  • National Taiwan University Hospital East Campus

    Taipei, 100225, Taiwan

  • Nizhniy Novgorod Regional Clinical Hospital Nasemashko

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    Norwich, NR4 7UY, United Kingdom

  • North Shore Hospital

    Takapuna, 0622, New Zealand

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB, United Kingdom

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Peninsula Private Hospital

    Frankston, Victoria, 3199, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57201, United States

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102, Australia

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000, China

  • Research Medical Center

    Kansas City, Missouri, 64132, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Russian Academy of Advanced Medical Studies, City Clinical Hospital

    Moscow, Moscow, 115478, Russia

  • Ryazan Regional Clinical Hospital

    Ryazan, Ryazan Oblast, 390039, Russia

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 416 85, Sweden

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500, Poland

  • Sarah Cannon Research Institute Uk

    London, W1G 6AD, United Kingdom

  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

    Chongqing, Chongqing Municipality, 400037, China

  • Skanes Universitetssjukhus I Lund

    Lund, 221 85, Sweden

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • State Budgetary Healthcare Institution Regional Clinical Dispensary

    Penza, Penza Oblast, 440071, Russia

  • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary

    Volgograd, Volgograd Oblast, 400138, Russia

  • State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment

    Perm, Permskiy Kray, 614077, Russia

  • State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region

    Sochi, Krasnodarskiy Kray, 354057, Russia

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP, United Kingdom

  • Sverdlovsk Regional Clinical Hospital

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200, Poland

  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

    Gdynia, 81-519, Poland

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Tauranga Hospital

    Tauranga, 3112, New Zealand

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee, 37203, United States

  • The Christie Hospital

    Greater Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University Branch Shizi

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF, United Kingdom

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW, United Kingdom

  • The Royal Wolverhampton Nhs Trust

    Wolverhampton, WV10 0QP, United Kingdom

  • The Tweed Valley Hospital

    Cudgen, New South Wales, 2487, Australia

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tula Area Clinical Hospital

    Tula, Tula Oblast, 300053, Russia

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

    Wuhan, Hubei, 430022, China

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124, Italy

  • Universita Degli Studi La Sapienza

    Roma, 00161, Italy

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Universitetssjukhuset Orebro

    Örebro, 701 85, Sweden

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Uppsala Akademiska Sjukhus

    Uppsala, 75185, Sweden

  • Va Puget Sound Health Care System

    Seattle, Washington, 98108, United States

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000, Czechia

  • Washington University

    St Louis, Missouri, 63110, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510, Poland

  • Wojewodzki Szpital Specjalistyczny W Legnicy

    Legnica, 59-220, Poland

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023, China

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