Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL (SEQUOIA)

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
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

Detailed Description:
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.

Layout table for study information
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


Arm Intervention/treatment
Experimental: Zanubrutinib (patients without del[17p])
Approximately 225 subjects in Cohort 1 to receive zanubrutinib
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: B+R
Approximately 225 subjects in Cohort 1 to receive bendamustine plus rituximab
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

Experimental: Zanubrutinib patients with del[17p])
Approximately 100 subjects in Cohort 2 to receive zanubrutinib
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
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 :
  1. 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 :
  1. Overall response rate between treatment groups in Cohort 1 [ Time Frame: Up to 5 years. ]
  2. Overall survival between treatment groups in Cohort 1. [ Time Frame: Up to 5 years. ]
  3. Duration of response between treatment groups in Cohort 1. [ Time Frame: Up to 5 years. ]
  4. Progression-free survival between treatment groups in Cohort 1 determined by investigator assessment (IA). [ Time Frame: Up to 5 years. ]
  5. Patient-reported outcomes in Cohort 1 measured by the EQ-5D-5L questionnaire. [ Time Frame: Up to 5 years. ]
  6. Overall response rate in Cohort 2. [ Time Frame: Up to 5 years. ]
  7. Progression-free survival in Cohort 2 as determined by ICR. [ Time Frame: Up to 5 years. ]
  8. Duration of response in Cohort 2 as determined by ICR. [ Time Frame: Up to 5 years. ]
  9. Overall response rate in Cohort 3. [ Time Frame: Up to 5 years. ]
  10. Progression-free survival in Cohort 3 as determined by ICR. [ Time Frame: Up to 5 years. ]
  11. Duration of response in Cohort 3 as determined by ICR. [ Time Frame: Up to 5 years. ]
  12. Rate of undetectable minimal residual disease in Cohort 3. [ Time Frame: Up to 5 years. ]
  13. Descriptive statistics will be used to summarize rate of adverse events. [ Time Frame: Up to 5 years. ]
  14. Plasma zanubrutinib concentrations will be summarized by scheduled time of collection. [ Time Frame: Up to 5 years. ]
  15. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

  Hide Study Locations
Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Jason Paik, MD BeiGene

Layout table for additonal information
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

Layout table for additional information
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:
Layout table for 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