Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT03873493
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2019-03-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015461', 'term': 'Leukemia, Prolymphocytic, T-Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C551803', 'term': 'ibrutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 10, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOACUSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MIDDLE EAR EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ANDROGEN DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EYE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GLOSSODYNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PANCREATIC STEATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TONGUE ERUPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CATHETER SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COMPLICATION ASSOCIATED WITH DEVICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERPLASTIC CHOLECYSTOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ESCHERICHIA URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FOLLICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ORAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PARVOVIRUS B19 INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RHINOVIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'WOUND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LYMPHOCYTE COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MAGNETIC RESONANCE IMAGING HEAD ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FOLATE DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOALBUMINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TUMOUR LYSIS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LIPOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL ATROPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MEMORY IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEVICE FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLADDER DIVERTICULUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASAL ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PETECHIAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SKIN LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTERIOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EUTHANASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ASPERGILLUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OROPHARYNGEAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FACET JOINT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MALIGNANT NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MALIGNANT PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RENAL TUBULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment', 'description': 'ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019.\n\nCR: All of the following response criteria must be met:\n\nGroup A:\n\n* all lymph nodes \\< 1 cm;\n* spleen \\< 13 cm;\n* no constitutional symptoms;\n* circulating lymphocyte count \\< 4 × 10\\^9/L;\n* bone marrow T-PLL cells \\< 5% of mononuclear cells;\n* no other specific site involvement\n\nGroup B:\n\n* platelets ≥ 100 × 10\\^9 /L;\n* hemoglobin ≥ 11.0 g/dL;\n* neutrophils ≥ 1.5 × 10\\^9 /L.\n\nCRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity.\n\nPR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes all participants who received at least 1 dose of study drug (either venetoclax or ibrutinib).'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods.\n\nResponse was assessed by the investigator based on the T-PLL consensus criteria 2019.\n\nProgressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods.\n\nResponse was assessed by the investigator based on the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with a best overall response of CR, CRi, or PR'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods.\n\nClinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods.\n\nClinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment', 'description': 'DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019.\n\nStable disease is defined as meeting all of the following criteria for at least 3 months:\n\n* lymph nodes change of -29% to +20% in SLD;\n* spleen change of -49% to +49% beyond normal from baseline;\n* circulating lymphocyte count \\> 30 × 10\\^9 /L or change of -49% to +49%;\n* platelet count change of -49% to +49%;\n* hemoglobin \\< 11.0 g/dL or change \\< 50% from baseline or change \\< 2 g/dL;\n* neutrophils change of -49% to +49%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were transplant-naive and achieved CR. No participants achieved a CR to be eligible for transplant.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'AE with NCI-CTCAE toxicity Grade 3, 4, or 5', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to venetoclax discontinuation, incl PD', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to venetoclax interruption', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to venetoclax reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AE with reasonable possibility related to venetoclax', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to ibrutinib discontinuation, incl PD', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to ibrutinib interruption', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to ibrutinib reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AE with reasonable possibility related to ibrutinib', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Serious AE with reasonable possibility related to venetoclax', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Serious AE with reasonable possibility related to ibrutinib', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to death', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'All deaths', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug.\n\nA serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome.\n\nThe Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.\n\nThe Investigator assessed the relationship of the AE to the use of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (either venetoclax or ibrutinib)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'In total, 16 adults with relapsed or refractory T-cell prolymphocytic leukemia (R/R T-PLL) were screened, and 14 participants were enrolled across 10 sites in 7 countries (Australia, France, Germany, Italy, Netherlands, United Kingdom, and United States).', 'preAssignmentDetails': 'This study was planned as an adaptive 2-stage design with Stage 1 to enroll 14 participants and Stage 2 to enroll up to an additional 23 participants based on the number of responders in Stage 1. Results from Stage 1 met the protocol-defined stopping rules, hence Stage 2 was not opened for enrollment. Stage 1 was completed as planned.\n\nFor one participant "study terminated by sponsor" was entered as study discontinuation reason by mistake.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '9.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 40 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '40 - < 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Duration', 'classes': [{'categories': [{'measurements': [{'value': '3.229', 'spread': '3.2134', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': '0 (Fully active)', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '1 (Restricted activity but ambulatory and able to work)', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '2 (Ambulatory but unable to work)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG performance status was assessed as follows:\n\n* 0: Fully active, able to carry on all predisease performance without restriction.\n* 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.\n* 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n* 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n* 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-11', 'size': 6037436, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-27T12:33', 'hasProtocol': True}, {'date': '2019-07-18', 'size': 273705, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-27T12:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2019-03-12', 'resultsFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-23', 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment', 'description': 'ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019.\n\nCR: All of the following response criteria must be met:\n\nGroup A:\n\n* all lymph nodes \\< 1 cm;\n* spleen \\< 13 cm;\n* no constitutional symptoms;\n* circulating lymphocyte count \\< 4 × 10\\^9/L;\n* bone marrow T-PLL cells \\< 5% of mononuclear cells;\n* no other specific site involvement\n\nGroup B:\n\n* platelets ≥ 100 × 10\\^9 /L;\n* hemoglobin ≥ 11.0 g/dL;\n* neutrophils ≥ 1.5 × 10\\^9 /L.\n\nCRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity.\n\nPR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods.\n\nResponse was assessed by the investigator based on the T-PLL consensus criteria 2019.\n\nProgressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods.\n\nResponse was assessed by the investigator based on the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods.\n\nClinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL."}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods.\n\nClinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.\n\nProgressive disease is defined as meeting at least one of the criteria of Group A or Group B below:\n\nGroup A:\n\n* lymph nodes increase in \\> 20% in SLD from nadir;\n* spleen increase ≥ 50% in vertical length beyond normal from baseline;\n* circulating lymphocyte count increase ≥ 50% from baseline;\n* appearance of a new lesion;\n\nGroup B:\n\n* platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);\n* hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;\n* neutrophils decrease of ≥ 50% from baseline due to T-PLL."}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment', 'description': 'DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019.\n\nStable disease is defined as meeting all of the following criteria for at least 3 months:\n\n* lymph nodes change of -29% to +20% in SLD;\n* spleen change of -49% to +49% beyond normal from baseline;\n* circulating lymphocyte count \\> 30 × 10\\^9 /L or change of -49% to +49%;\n* platelet count change of -49% to +49%;\n* hemoglobin \\< 11.0 g/dL or change \\< 50% from baseline or change \\< 2 g/dL;\n* neutrophils change of -49% to +49%.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': "Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods."}, {'measure': 'Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation', 'timeFrame': 'From first dose of study drug to end of study; median time on study was 30.1 weeks.', 'description': 'Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'timeFrame': 'From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug.\n\nA serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome.\n\nThe Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.\n\nThe Investigator assessed the relationship of the AE to the use of study drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-cell Prolymphocytic Leukemia (T-PLL)', 'Cancer', 'Venetoclax', 'Venclexta', 'Venclyxto', 'Ibrutinib', 'Imbruvica', 'Relapsed or Refractory T-lymphoid malignancy'], 'conditions': ['Leukemia', 'T-cell Prolymphocytic Leukemia (T-PLL)', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).', 'detailedDescription': 'This study is planned as an adaptive 2-stage design as follows:\n\nStage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.\n\nStage 2: Enroll up to an additional 23 participants.\n\nThe study was stopped after Stage 1. Stage 2 was not conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adequate liver, kidney and hematology function per laboratory values as described in the protocol.\n* Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* Received prior alemtuzumab (unless unsuitable or unavailable).\n* Has no malignancies other than T-PLL that:\n\n * currently require systemic therapies;\n * were not previously treated with curative intention (unless the malignant disease is in a stable remission due to the discretion of the treating physician); or\n * developed signs of progression after curative treatment.\n\nExclusion Criteria:\n\n* History of or current decompensated cirrhosis including Child-Pugh class B or C, ascites, hepatic encephalopathy, or variceal bleeding.\n* Has human T-cell lymphotropic virus, type 1.\n* Prior allogeneic stem cell transplant within 6 months of study drug administration and requirement for graft versus host therapy.\n* Has an uncontrolled or active infection including severe acute respiratory syndrome- coronavirus-2 (SARS-COV-2).\n* Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.\n* Received a prohibited therapy within the specified time frame as described in the protocol.'}, 'identificationModule': {'nctId': 'NCT03873493', 'briefTitle': 'A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'M18-803'}, 'secondaryIdInfos': [{'id': '2018-002179-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax + Ibrutinib', 'description': 'Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Ibrutinib']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['ABT-199', 'GDC-0199', 'Venclexta®', 'Venclyxto®'], 'description': 'Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.', 'armGroupLabels': ['Venetoclax + Ibrutinib']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['Imbruvica®'], 'description': 'Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.', 'armGroupLabels': ['Venetoclax + Ibrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute /ID# 207728', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester /ID# 207692', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center /ID# 207746', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Ctr /ID# 209554', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitaet Wien /ID# 208497', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '00290', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Helsinki University Hospital /ID# 208108', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'HCL - Hôpital Lyon Sud /ID# 208731', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHRU Lille - Hopital Claude Huriez /ID# 208726', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Pitie Salpetriere /ID# 208730', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Cologne /ID# 208834', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '34128', 'city': 'Trieste', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '5631 BM', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum /ID# 207989', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen /ID# 207990', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust /ID# 211264', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust /ID# 211263', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}