Viewing Study NCT04965493


Ignite Creation Date: 2025-12-25 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
Study NCT ID: NCT04965493
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-09-02
First Post: 2021-07-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, 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': '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'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723100', 'term': 'pirtobrutinib'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients will be randomized 1:1 into Arm A and Arm B.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of Arm A compared to Arm B: Progression-free survival (PFS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessments of efficacy include PFS, assessed by investigator'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessments of efficacy include OS'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessments of efficacy include TTNT'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessments of efficacy include EFS'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Assessments of efficacy include ORR'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B in patient-reported disease-related symptoms', 'timeFrame': 'Up to approximately 5 years', 'description': 'Based on time to worsening of CLL/SLL-related symptoms'}, {'measure': 'To evaluate the efficacy of Arm A compared to Arm B in patient-reported physical functioning', 'timeFrame': 'Up to approximately 5 years', 'description': 'Based on time to worsening of physical functioning'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BTKi', 'Hematologic Disease', "Lymphoma, non-Hodgkin's", 'Lymphoma, B-cell'], 'conditions': ['Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/295939', 'label': 'A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (BRUIN CLL-322)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria\n* Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor\n* Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L\n* Adequate organ function\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Estimated creatinine clearance ≥30 milliliters per minute (mL/min)\n\nExclusion Criteria:\n\n* Known or suspected Richter's transformation at any time preceding enrollment\n* Prior therapy with a non-covalent (reversible) BTK inhibitor\n* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n* Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers\n* Prior therapy with venetoclax\n* Central nervous system (CNS) involvement\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n* Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days\n* Active hepatitis B or hepatitis C\n* Known active cytomegalovirus (CMV) infection\n* Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)\n* Significant cardiovascular disease\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Patients with the following hypersensitivity:\n\n * Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax\n * Prior significant hypersensitivity to rituximab\n * Known allergy to allopurinol and inability to take uric acid lowering agent"}, 'identificationModule': {'nctId': 'NCT04965493', 'acronym': 'BRUIN CLL-322', 'briefTitle': 'A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)', 'orgStudyIdInfo': {'id': '18087'}, 'secondaryIdInfos': [{'id': 'J2N-OX-JZNO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'LOXO-BTK-20022', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (PVR)', 'description': 'Fixed duration pirtobrutinib in combination with venetoclax and rituximab', 'interventionNames': ['Drug: Pirtobrutinib', 'Drug: Venetoclax', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B (VR)', 'description': 'Venetoclax with rituximab', 'interventionNames': ['Drug: Venetoclax', 'Drug: Rituximab']}], 'interventions': [{'name': 'Pirtobrutinib', 'type': 'DRUG', 'otherNames': ['LOXO-305', 'LY3527727'], 'description': 'Oral', 'armGroupLabels': ['Arm A (PVR)']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta', 'Venclyxto'], 'description': 'Oral', 'armGroupLabels': ['Arm A (PVR)', 'Arm B (VR)']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan', 'MabThera', 'Truxima', 'Riabni', 'Ruxience'], 'description': 'Intravenous (IV)', 'armGroupLabels': ['Arm A (PVR)', 'Arm B (VR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Physicians, Ironwood Cancer and Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Mercy Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Hospital', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33916-2233', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Specialists of North Florida -St Augustine', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists East', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mission Cancer and Blood', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '41501', 'city': 'Pikeville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pikeville Medical Center, Inc.', 'geoPoint': {'lat': 37.47927, 'lon': -82.51876}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'American Oncology Partners of Maryland, PA', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905-0002', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': 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'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3065', 'city': 'Melbourne', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Groupe Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'CHU UCL Namur site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Sunnybrook Research Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'BC Cancer Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1M3', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Cancer Care Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 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