Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT03336333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2017-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021)', 'description': 'All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Bendamustine + Rituximab Without Del(17p)', 'description': 'Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\\^2 for Cycle 1 and 500 mg/m\\^2 for Cycles 2 to 6 (each cycle is 28 days)', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 238, 'otherNumAffected': 214, 'seriousNumAtRisk': 227, 'deathsNumAffected': 14, 'seriousNumAffected': 113}, {'id': 'EG001', 'title': 'Cohort 1: Zanubrutinib Without Del(17p)', 'description': 'Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 241, 'otherNumAffected': 208, 'seriousNumAtRisk': 240, 'deathsNumAffected': 16, 'seriousNumAffected': 88}, {'id': 'EG002', 'title': 'Cohort 2: Zanubrutinib With Del(17p)', 'description': 'Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 104, 'seriousNumAtRisk': 111, 'deathsNumAffected': 8, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 65, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 233, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 62, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 28, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 62, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 49, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 42, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 107, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 52, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 37, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 69, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 53, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 28, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 29, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 58, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 31, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 44, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 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Survival (PFS)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cohort 2: Duration of Response (DOR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cohort 3: Overall Response Rate (ORR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cohort 3: Progression-free Survival (PFS)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cohort 3: Duration of Response (DOR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cohort 3: Rate of Undetectable Minimal Residual Disease (MRD4)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F', 'timeFrame': 'Predose up to 12 hours postdose'}, {'measure': 'Cohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12)', 'timeFrame': 'Predose up to 12 hours postdose'}, {'measure': 'Cohort 3: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) of Zanubrutinib', 'timeFrame': 'Predose up to 12 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['zanubrutinib', 'BTK inhibitor', 'bendamustine', 'rituximab', 'venetoclax', 'BGB-3111', 'Phase 3'], 'conditions': ['Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma']}, 'referencesModule': {'references': [{'pmid': '31875923', 'type': 'RESULT', 'citation': "Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26."}, {'pmid': '33054121', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '40944848', 'type': 'DERIVED', 'citation': '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 Dec;13(4):1055-1070. doi: 10.1007/s40487-025-00380-0. Epub 2025 Sep 13.'}, {'pmid': '40448577', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39647999', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38598745', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38502198', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37752878', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35810754', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)\n* Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment\n* Measurable disease by imaging\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Life expectancy ≥ 6 months\n* Adequate bone marrow function\n* Adequate renal and hepatic function\n\nKey Exclusion Criteria:\n\n* Previous systemic treatment for CLL/SLL\n* Requires ongoing need for corticosteroid treatment\n* Known prolymphocytic leukemia or history of or suspected Richter's transformation.\n* Clinically significant cardiovascular disease\n* 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\n* History of severe bleeding disorder\n* History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug\n* Severe or debilitating pulmonary disease\n* Inability to swallow capsules or disease affecting gastrointestinal function\n* Active infection requiring systemic treatment\n* Known central nervous system involvement by leukemia or lymphoma\n* Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs\n* Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection\n* Major surgery ≤ 4 weeks prior to start of study treatment\n* Pregnant or nursing females\n* Vaccination with live vaccine within 35 days prior to the first dose of study drug.\n* Ongoing alcohol or drug addiction\n* Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs\n* Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer\n* Concurrent participation in another therapeutic clinical study\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03336333', 'acronym': 'SEQUOIA', 'briefTitle': 'A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'BGB-3111-304'}, 'secondaryIdInfos': [{'id': '2017-001551-31', 'type': 'EUDRACT_NUMBER'}, {'id': 'CTR20190416', 'type': 'REGISTRY', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Bendamustine + Rituximab', 'description': 'Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Zanubrutinib', 'description': 'Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1a (China only): Bendamustine + Rituximab', 'description': 'Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1a (China only): Zanubrutinib', 'description': 'Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Zanubrutinib', 'description': 'Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Venetoclax + Zanubrutinib', 'description': '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)', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Venetoclax']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['BGB-3111', 'BRUKINSA'], 'description': 'Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)', 'armGroupLabels': ['Cohort 1: Zanubrutinib', 'Cohort 1a (China only): Zanubrutinib', 'Cohort 2: Zanubrutinib', 'Cohort 3: Venetoclax + Zanubrutinib']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda, Ribomustin, and Levact'], 'description': 'Administered intravenously (IV) at a dose of 90 mg/m\\^2/day on the first 2 days of each cycle for 6 cycles.', 'armGroupLabels': ['Cohort 1: Bendamustine + Rituximab', 'Cohort 1a (China only): Bendamustine + Rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan, MabThera'], 'description': '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', 'armGroupLabels': ['Cohort 1: Bendamustine + Rituximab', 'Cohort 1a (China only): Bendamustine + Rituximab']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta, Venclyxto'], 'description': '400 mg tablets administered orally once daily.', 'armGroupLabels': ['Cohort 3: Venetoclax + Zanubrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07932', 'city': 'Florham Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Summit Medical Group', 'geoPoint': {'lat': 40.78788, 'lon': -74.38821}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine At Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 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