A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL (SEQUOIA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03336333 |
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Recruitment Status :
Recruiting
First Posted : November 8, 2017
Last Update Posted : November 4, 2019
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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Brief Summary:
This study will enroll subjects with previously untreated CLL/SLL into three cohorts (Cohort 1 without del[17p] and Cohorts 2 and 3 with del[17p]). Cohort 1 subjects will receive either zanubrutinib alone or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive zanubrutinib alone. Once Cohort 2 has finished enrollment, Cohort 3 will be opened in selected countries/sites where patients will receive zanubrutinib and venetoclax. The primary purpose is to evaluate the efficacy and safety of zanubrutinib versus bendamustine and rituximab in Cohort 1.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | Drug: Zanubrutinib Drug: Bendamustine Drug: Rituximab Drug: Venetoclax | Phase 3 |
This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in subjects with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including subjects without del(17p) [Cohort 1] and subjects with del(17p) [Cohort 2 and Cohort 3]. Subjects 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. Subjects in Cohort 2 will receive treatment with zanubrutinib. Subjects in Cohort 3 will receive treatment with zanubrutinib and venetoclax.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | November 2, 2017 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | October 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Zanubrutinib (patients without del[17p])
Approximately 225 subjects in Cohort 1 to receive zanubrutinib
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Drug: Zanubrutinib
Zanubrutinib will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Other Name: BGB-3111 |
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Experimental: B+R
Approximately 225 subjects in Cohort 1 to receive bendamustine plus rituximab
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Drug: Bendamustine
Bendamustine will be administered intravenously at a dose of 90 mg/m2/day on the first 2 days of each cycle for 6 cycles. 1 cycle = 28 days.
Other Name: Treanda, Ribomustin, and Levact Drug: Rituximab Rituximab will be administered intravenously at a dose of 375 mg/m2 on day 0 of cycle 1, and at a dose of 500 mg/m2 on day 1 of cycles 2 to 6. 1 cycle = 28 days.
Other Name: Rituxan, MabThera |
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Experimental: Zanubrutinib patients with del[17p])
Approximately 100 subjects in Cohort 2 to receive zanubrutinib
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Drug: Zanubrutinib
Zanubrutinib will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Other Name: BGB-3111 |
|
Experimental: Zanubrutinib and venetoclax (patients with del[17p])
Approximately 50 subjects in Cohort 3 to receive BGB-3111 and venetoclax
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Drug: Zanubrutinib
Zanubrutinib will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Other Name: BGB-3111 Drug: Venetoclax Venetoclax will be administered by mouth once daily.
Other Name: Venclexta, Venclyxto |
Primary Outcome Measures :
- Progression-free survival between treatment groups in Cohort 1 (Zanubrutinib vs. B+R) as determined by independent central review (ICR). [ Time Frame: Up to 5 years. ]
Secondary Outcome Measures :
- Overall response rate between treatment groups in Cohort 1 [ Time Frame: Up to 5 years. ]
- Overall survival between treatment groups in Cohort 1. [ Time Frame: Up to 5 years. ]
- Duration of response between treatment groups in Cohort 1. [ Time Frame: Up to 5 years. ]
- Progression-free survival between treatment groups in Cohort 1 determined by investigator assessment (IA). [ Time Frame: Up to 5 years. ]
- Patient-reported outcomes in Cohort 1 measured by the EQ-5D-5L questionnaire. [ Time Frame: Up to 5 years. ]
- Overall response rate in Cohort 2. [ Time Frame: Up to 5 years. ]
- Progression-free survival in Cohort 2 as determined by ICR. [ Time Frame: Up to 5 years. ]
- Duration of response in Cohort 2 as determined by ICR. [ Time Frame: Up to 5 years. ]
- Overall response rate in Cohort 3. [ Time Frame: Up to 5 years. ]
- Progression-free survival in Cohort 3 as determined by ICR. [ Time Frame: Up to 5 years. ]
- Duration of response in Cohort 3 as determined by ICR. [ Time Frame: Up to 5 years. ]
- Rate of undetectable minimal residual disease in Cohort 3. [ Time Frame: Up to 5 years. ]
- Descriptive statistics will be used to summarize rate of adverse events. [ Time Frame: Up to 5 years. ]
- Plasma zanubrutinib concentrations will be summarized by scheduled time of collection. [ Time Frame: Up to 5 years. ]
- Patient-reported outcomes in Cohort 1 measured by the EORTC QLQ-C30 questionnaire. [ Time Frame: Up to 5 years. ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: All subjects
- Unsuitable for chemoimmunotherapy with FCR
- Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment.
- Measurable disease by imaging
- ECOG performance status of 0, 1 or 2.
- Life expectancy ≥ 6 months.
- Adequate bone marrow function.
- Adequate renal and hepatic function.
Exclusion Criteria: All subjects
- 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 CYP3A inhibitor or inducer.
- Concurrent participation in another therapeutic clinical trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336333
Contacts
| Contact: BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
Hide Study Locations
Locations
| United States, District of Columbia | |
| Georgetown University Medical Center | Active, not recruiting |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| Emory University | Active, not recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Augusta University | Active, not recruiting |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60208 | |
| United States, Kentucky | |
| Montgomery Cancer Center | Active, not recruiting |
| Mount Sterling, Kentucky, United States, 40353 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Research Medical Center - Kansas | Active, not recruiting |
| Kansas City, Missouri, United States, 64132 | |
| Washington University | Active, not recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | Active, not recruiting |
| Las Vegas, Nevada, United States, 89014 | |
| United States, New Jersey | |
| Summit Medical Group, PA | Active, not recruiting |
| Florham Park, New Jersey, United States, 07932 | |
| United States, New York | |
| Mount Sinai | Active, not recruiting |
| New York, New York, United States, 10029 | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Memorial Sloan Kettering Cancer Center | Active, not recruiting |
| New York, New York, United States, 10065 | |
| University of Rochester | Active, not recruiting |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke University Medical Center | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| United States, South Dakota | |
| Prairie Lakes Healthcare System | Active, not recruiting |
| Watertown, South Dakota, United States, 57201 | |
| United States, Tennessee | |
| Tennessee Oncology - Centennial Clinic | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Joe Arrington Cancer Research and Treatment Center | Active, not recruiting |
| Lubbock, Texas, United States, 79410 | |
| Texas Oncology - Tyler | Active, not recruiting |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113 | Active, not recruiting |
| Seattle, Washington, United States, 98108 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Australia, New South Wales | |
| Concord Hospital | Active, not recruiting |
| Concord, New South Wales, Australia, 2139 | |
| The Tweed Hospital | Active, not recruiting |
| Tweed Heads, New South Wales, Australia | |
| Calvary Mater Newcastle Hospital | Active, not recruiting |
| Waratah, New South Wales, Australia | |
| Westmead Hospital | Active, not recruiting |
| Westmead, New South Wales, Australia | |
| Australia, Queensland | |
| Icon Cancer Care - Wesley | Active, not recruiting |
| Auchenflower, Queensland, Australia | |
| Royal Brisbane and Women's Hospital | Active, not recruiting |
| Herston, Queensland, Australia | |
| Princess Alexandra Hospital | Active, not recruiting |
| Woolloongabba, Queensland, Australia | |
| Australia, South Australia | |
| Royal Adelaide Hospital | Active, not recruiting |
| Adelaide, South Australia, Australia | |
| The Queen Elizabeth Hospital | Active, not recruiting |
| Woodville South, South Australia, Australia | |
| Australia, Tasmania | |
| Royal Hobart Hospital | Active, not recruiting |
| Hobart, Tasmania, Australia | |
| Australia, Victoria | |
| Monash Medical Centre | Recruiting |
| Bentleigh East, Victoria, Australia | |
| Box Hill Hospital | Active, not recruiting |
| Box Hill, Victoria, Australia | |
| Peter MacCallum Cancer Centre | Recruiting |
| East Melbourne, Victoria, Australia | |
| Saint Vincent's Hospital Melbourne | Active, not recruiting |
| Fitzroy, Victoria, Australia | |
| Peninsula Private Hospital | Recruiting |
| Frankston, Victoria, Australia | |
| Australia, Western Australia | |
| Royal Perth Hospital | Active, not recruiting |
| Perth, Western Australia, Australia | |
| Australia | |
| Icon Cancer Care - South Brisbane | Active, not recruiting |
| South Brisbane, Australia | |
| Austria | |
| Medizinische Universitätsklinik Innsbruck | Active, not recruiting |
| Innsbruck, Austria | |
| Allgemeines Krankenhaus der Stadt Linz | Active, not recruiting |
| Linz, Austria | |
| Krankenhaus der Barmherzigen Schwestern Linz | Active, not recruiting |
| Linz, Austria | |
| Universitätsklinik für Innere Medizin Salzburg | Active, not recruiting |
| Salzburg, Austria | |
| Klinikum Wels-Grieskirchen | Active, not recruiting |
| Wels, Austria | |
| Belgium | |
| GasthuisZusters Antwerpen Sint-Augustinus | Active, not recruiting |
| Wilrijk, Antwerpen, Belgium | |
| Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne | Active, not recruiting |
| Yvoir, Namur, Belgium | |
| Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph | Active, not recruiting |
| Arlon, Belgium | |
| Universitair Ziekenhuis Brussel | Active, not recruiting |
| Brussels, Belgium | |
| Universitair Ziekenhuis Gent | Active, not recruiting |
| Gent, Belgium | |
| Centre Hospitalier Universitaire (CHU) de Liège - Site du Sart Tilman | Active, not recruiting |
| Liège, Belgium | |
| Clinique Saint-Pierre | Active, not recruiting |
| Ottignies, Belgium | |
| Czechia | |
| Fakultní Nemocnice Brno | Active, not recruiting |
| Brno, Czechia | |
| Fakultní Nemocnice Hradec Králové - Ústav Klinické Imunologie a Alergologie | Active, not recruiting |
| Hradec Králové, Czechia | |
| Fakultní Nemocnice Olomouc | Active, not recruiting |
| Olomouc, Czechia | |
| Fakultní Nemocnice Ostrava | Active, not recruiting |
| Ostrava-Poruba, Czechia | |
| Všeobecná Fakultní Nemocnice v Praze | Active, not recruiting |
| Praha, Czechia | |
| France | |
| Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard | Active, not recruiting |
| Poitiers Cedex, Poitou-charentes, France | |
| Centre Hospitalier Victor Dupouy d'Argenteuil | Active, not recruiting |
| Argenteuil, France | |
| Institut Bergonié | Active, not recruiting |
| Bordeaux, France | |
| CHU de Caen Côte de Nacre | Active, not recruiting |
| Caen, France | |
| Centre Hospitalier Départemental Vendée | Active, not recruiting |
| La Roche sur Yon, France | |
| Centre Hospitalier Le Mans | Recruiting |
| Le Mans, France | |
| Centre Hospitalier Universitaire Limoges CHU de Limoges | Active, not recruiting |
| Limoges, France | |
| Centre Léon Bérard | Active, not recruiting |
| Lyon, France | |
| Institut Paoli Calmettes | Active, not recruiting |
| Marseille, France | |
| Centre Hospitalier Universitaire Nantes - Hotel Dieu | Active, not recruiting |
| Nantes, France | |
| Groupe Hospitalier Pitie-Salpetriere | Recruiting |
| Paris, France | |
| Groupe Hospitalier du Haut Leveque | Active, not recruiting |
| Pessac, France | |
| Centre hospitalier Lyon Sud | Recruiting |
| Pierre-Bénite, France | |
| Hôpital Robert Debré | Active, not recruiting |
| Reims, France | |
| Hôpital Pontchaillou | Active, not recruiting |
| Rennes, France | |
| Centre Henri-Becquerel | Active, not recruiting |
| Rouen, France | |
| Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau | Active, not recruiting |
| Tours, France | |
| Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois | Active, not recruiting |
| Vandoeuvre-lès-Nancy, France | |
| Italy | |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Active, not recruiting |
| Brescia, Italy | |
| Presidio Ospedale di Montichiari | Active, not recruiting |
| Brescia, Italy | |
| Presidio Ospedaliero di Gardone Val Trompia | Active, not recruiting |
| Brescia, Italy | |
| Azienda Ospedaliera Universitaria San Martino | Active, not recruiting |
| Genova, Italy | |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Active, not recruiting |
| Meldola, Italy | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Recruiting |
| Milano, Italy | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Active, not recruiting |
| Milano, Italy | |
| Ospedale San Raffaele | Recruiting |
| Milano, Italy | |
| Universita Degli Studi di Modena-Azienda Ospedaliere Policlinco | Active, not recruiting |
| Modena, Italy | |
| Azienda Unita Sanitaria Locale di Ravenna | Recruiting |
| Ravenna, Italy | |
| Fondazione Policlinico Universitario Agostino Gemelli | Active, not recruiting |
| Roma, Italy | |
| Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma | Active, not recruiting |
| Roma, Italy | |
| Ospedale Casa Sollievo della Sofferenza | Active, not recruiting |
| San Giovanni Rotondo, Italy | |
| Azienda Ospedaliera Santa Maria di Terni | Active, not recruiting |
| Terni, Italy | |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Active, not recruiting |
| Torino, Italy | |
| New Zealand | |
| North Shore Hospital | Recruiting |
| North Shore, Auckland, New Zealand | |
| Auckland City Hospital | Active, not recruiting |
| Grafton, Aukland, New Zealand | |
| Palmerston North Hospital | Active, not recruiting |
| Palmerston North, Manawatu-wanganui, New Zealand | |
| Christchurch Hospital | Active, not recruiting |
| Christchurch, New Zealand | |
| Tauranga Hospital | Active, not recruiting |
| Tauranga, New Zealand | |
| Poland | |
| Wojewódzki Szpital Specjalistyczny w Legnicy | Active, not recruiting |
| Legnica, Dolnoslaskie, Poland | |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza | Active, not recruiting |
| Brzozów, Poland | |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich | Active, not recruiting |
| Chorzów, Poland | |
| Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii | Active, not recruiting |
| Gdańsk, Poland | |
| Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością | Active, not recruiting |
| Gdynia, Poland | |
| Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach | Active, not recruiting |
| Gliwice, Poland | |
| Malopolskie Centrum Medyczne | Recruiting |
| Kraków, Poland | |
| Centrum Onkologii Ziemi Lubelskiej | Active, not recruiting |
| Lublin, Poland | |
| Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi | Recruiting |
| Łódź, Poland | |
| Russian Federation | |
| Sverdlovsk Regional Clinical Hospital #1 | Active, not recruiting |
| Ekaterinburg, Russian Federation | |
| Kaluga Regional Hospital | Active, not recruiting |
| Kaluga, Russian Federation | |
| Clinical Oncology Dispensary, Kazan | Active, not recruiting |
| Kazan, Russian Federation | |
| Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev | Active, not recruiting |
| Kemerovo, Russian Federation | |
| City Clinical Hospital No. 52 of the Moscow Healthcare Department | Active, not recruiting |
| Moscow, Russian Federation | |
| N. N. Blokhin Russian Cancer Research Center | Active, not recruiting |
| Moscow, Russian Federation | |
| Nizhniy Novgorod Regional Clinical Hospital N.A. | Active, not recruiting |
| Nizhny Novgorod, Russian Federation | |
| Penza Regional Oncology Dispensary | Active, not recruiting |
| Penza, Russian Federation | |
| Municipal Healthcare Institution "Clinical Medical Sanitary Establishment #1" | Active, not recruiting |
| Perm, Russian Federation | |
| Ryazan Regional Clinical Hospital | Active, not recruiting |
| Ryazan, Russian Federation | |
| FGU Russian Scientific Research Institute of Hematology and Transfusiology | Active, not recruiting |
| Saint Petersburg, Russian Federation | |
| State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region | Active, not recruiting |
| Sochi, Russian Federation | |
| Tula Area Clinical Hospital | Active, not recruiting |
| Tula, Russian Federation | |
| State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1" | Active, not recruiting |
| Volgograd, Russian Federation | |
| Central City Hospital # 7 | Active, not recruiting |
| Yekaterinburg, Russian Federation | |
| Spain | |
| Institut Català d'Oncologia | Active, not recruiting |
| Badalona, Barcelona, Spain | |
| Hospital Universitari Parc Taulí | Active, not recruiting |
| Sabadell, Barcelona, Spain | |
| Hospital del Mar | Active, not recruiting |
| Barcelona, Spain | |
| Hospital Universitario Vall d'Hebron | Active, not recruiting |
| Barcelona, Spain | |
| Institut Català d'Oncologia - L'Hospitalet de Llobregat | Active, not recruiting |
| Barcelona, Spain | |
| Clinica Universidad de Navarra Madrid | Active, not recruiting |
| Madrid, Spain | |
| Hospital Universitario de La Princesa | Active, not recruiting |
| Madrid, Spain | |
| Hospital Universitario Ramón Y Cajal | Active, not recruiting |
| Madrid, Spain | |
| MD Anderson Cancer Center - Madrid | Active, not recruiting |
| Madrid, Spain | |
| Hospital Universitario Puerta de Hierro - Majadahonda | Active, not recruiting |
| Majadahonda, Spain | |
| Clínica Universidad de Navarra Pamplona | Active, not recruiting |
| Pamplona, Spain | |
| Hospital Universitario La Fe | Active, not recruiting |
| Valencia, Spain | |
| Hospital de Día Quirónsalud Zaragoza | Active, not recruiting |
| Zaragoza, Spain | |
| Sweden | |
| Skånes Universitetssjukhus i Lund | Active, not recruiting |
| Lund, Skane, Sweden | |
| Södra Älvsborgs Sjukhus - Borås | Active, not recruiting |
| Borås, Vastra Gotaland, Sweden | |
| Sahlgrenska Universitetssjukhuset, Östra sjukhuset | Active, not recruiting |
| Göteborg, Vastra Gotaland, Sweden | |
| Sunderby Sjukhus | Active, not recruiting |
| Lulea, Sweden | |
| Universitetssjukhuset Örebro | Active, not recruiting |
| Orebro, Sweden | |
| Karolinska Universitetssjukhuset - Solna | Recruiting |
| Stockholm, Sweden | |
| Uppsala Akademiska Sjukhus | Active, not recruiting |
| Uppsala, Sweden | |
| Taiwan | |
| Hualien Tzu Chi Hospital | Active, not recruiting |
| Hualien City, Taiwan | |
| Taipei Medical University - Shuang Ho Hospital | Active, not recruiting |
| New Taipei City, Taiwan | |
| Chi Mei Hospital Liouying | Active, not recruiting |
| Tainan City, Taiwan | |
| National Taiwan University Hospital | Active, not recruiting |
| Taipei, Taiwan | |
| United Kingdom | |
| Heart of England NHS Foundation Trust | Active, not recruiting |
| Birmingham, England, United Kingdom | |
| Cambridge University Hospitals NHS Foundation Trust | Active, not recruiting |
| Cambridge, England, United Kingdom | |
| East Kent Hospitals University NHS Foundation Trust | Active, not recruiting |
| Canterbury, England, United Kingdom | |
| Sarah Cannon Research Institute London | Active, not recruiting |
| London, England, United Kingdom | |
| Maidstone and Tunbridge Wells NHS Trust | Active, not recruiting |
| Maidstone, England, United Kingdom | |
| The Christie NHS Foundation Trust | Active, not recruiting |
| Manchester, England, United Kingdom | |
| The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Active, not recruiting |
| Bournemouth, United Kingdom | |
| The Leeds Teaching Hospitals NHS Trust | Recruiting |
| Leeds, United Kingdom | |
| Barts and The London NHS Trust | Active, not recruiting |
| London, United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Active, not recruiting |
| London, United Kingdom | |
| Norfolk and Norwich University Hospital | Active, not recruiting |
| Norwich, United Kingdom | |
| Nottingham University Hospitals NHS Trust | Active, not recruiting |
| Nottingham, United Kingdom | |
| Derriford Hospital | Active, not recruiting |
| Plymouth, United Kingdom | |
| Southampton General Hospital | Active, not recruiting |
| Southampton, United Kingdom | |
| City Hospitals Sunderland NHS Foundation Trust | Active, not recruiting |
| Sunderland, United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Active, not recruiting |
| Sutton, United Kingdom | |
| The Royal Wolverhampton NHS Trust | Active, not recruiting |
| Wolverhampton, United Kingdom | |
Sponsors and Collaborators
BeiGene
Investigators
| Study Director: | Jason Paik, MD | BeiGene |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT03336333 History of Changes |
| Other Study ID Numbers: |
BGB-3111-304 2017-001551-31 ( EudraCT Number ) CTR20190416 ( Registry Identifier: Center for drug evaluation, CFDA ) |
| First Posted: | November 8, 2017 Key Record Dates |
| Last Update Posted: | November 4, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by BeiGene:
|
zanubrutinib BTK inhibitor bendamustine rituximab |
venetoclax BGB-3111 Phase 3 |
Additional relevant MeSH terms:
|
Venetoclax Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Rituximab |
Bendamustine Hydrochloride Zanubrutinib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |