Viewing Study NCT03570892

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Ignite Creation Date: 2025-12-24 @ 3:31 PM
Ignite Modification Date: 2025-12-31 @ 8:15 PM
Study NCT ID: NCT03570892
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-12-04
First Post: 2018-06-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-3000', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years.', 'description': 'Any sign or symptom that occurs during the conduct of the trial and safety follow-up.\n\nOther Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.', 'eventGroups': [{'id': 'EG000', 'title': 'Tisagenlecleucel Treatment Strategy', 'description': "Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel", 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 159, 'seriousNumAtRisk': 162, 'deathsNumAffected': 52, 'seriousNumAffected': 76}, {'id': 'EG001', 'title': 'Standard of Care Treatment Strategy', 'description': "Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)", 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 158, 'seriousNumAtRisk': 160, 'deathsNumAffected': 45, 'seriousNumAffected': 82}, {'id': 'EG002', 'title': 'All Participants', 'description': 'All participants who were enrolled in the study', 'otherNumAtRisk': 322, 'deathsNumAtRisk': 322, 'otherNumAffected': 317, 'seriousNumAtRisk': 322, 'deathsNumAffected': 97, 'seriousNumAffected': 158}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 194}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 132}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 137}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 11}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 89}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 145}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 87}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 78}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 23}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 56}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 68}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 86}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 93}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 49}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 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'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 322, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tisagenlecleucel Treatment Strategy', 'description': "Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel"}, {'id': 'OG001', 'title': 'Standard of Care Treatment Strategy', 'description': "Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)"}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '4.2'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '3.5'}]}]}], 'analyses': [{'pValue': '= 0.694', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted stratified cox model hazard r', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.40', 'statisticalMethod': 'Stratified log-rank test one-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'appro. 24 months', 'description': 'Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) comprised all subjects to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS) as Assessed by Local Investigator', 'timeFrame': '5 years', 'description': 'Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'timeFrame': '5 years', 'description': 'Overall Response Rate (ORR) as per the Lugano criteria as per BIRC review and local investigator assessment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'timeFrame': '5 years', 'description': 'Duration of response: time from the date of first documented response of CR or PR to the date of first documented progression (SD or PD at or after the week 12 assessment will be considered progression) or death due to aggressive B-cell NHL. DOR will be summarized by BIRC and local response', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'timeFrame': '5 years', 'description': "Time from the date of randomization to the date of a patient's first achieved a response of CR or PR on or after the Week 12 assessment", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'SF-36v2', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in SF-36v2', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'FACT-Lym', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in FACT-Lym', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'EQ-VAS', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in EQ-VAS', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Tisagenlecleucel Transgene Concentrations', 'timeFrame': '5 years', 'description': 'qPCR will be used to measure tisagenlecleucel transgene concentrations in peripheral blood and bone marrow', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Tisagenlecleucel Immunogenicity (Humoral and Cellular)', 'timeFrame': '5 years', 'description': 'Pre-existing and treatment related immunogenicity (humoral and cellular) of tisagenlecleucel will be characterized.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}, {'type': 'SECONDARY', 'title': 'Presence of Replication Competent Lentivirus (RCL)', 'timeFrame': '5 years', 'description': 'The presence of RCL will be assessed by VSV-qPCR in patients receiving tisagenlecleucel', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-02'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tisagenlecleucel Treatment Strategy', 'description': "Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel"}, {'id': 'FG001', 'title': 'Standard of Care Treatment Strategy', 'description': "Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Study on-going at the time of data cut-off date of 6-May-2021', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted in 18 countries and 65 sites. Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed.', 'preAssignmentDetails': 'During the screening period, no lymphoma-specific therapy was allowed prior to randomization. During randomization, subjects were stratified by: Remission duration, international prognostic index (IPI) score and region.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tisagenlecleucel Treatment Strategy', 'description': "Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel"}, {'id': 'BG001', 'title': 'Standard of Care Treatment Strategy', 'description': "Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '13.74', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.99', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '13.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) comprised all subjects to whom study treatment was assigned by randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-18', 'size': 2724006, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-07T09:59', 'hasProtocol': True}, {'date': '2021-11-26', 'size': 1523205, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-07T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Open-Label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2018-06-18', 'resultsFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-06-28', 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment', 'timeFrame': 'appro. 24 months', 'description': 'Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival (EFS) as Assessed by Local Investigator', 'timeFrame': '5 years', 'description': 'Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': '5 years', 'description': 'Overall Response Rate (ORR) as per the Lugano criteria as per BIRC review and local investigator assessment'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': '5 years', 'description': 'Duration of response: time from the date of first documented response of CR or PR to the date of first documented progression (SD or PD at or after the week 12 assessment will be considered progression) or death due to aggressive B-cell NHL. DOR will be summarized by BIRC and local response'}, {'measure': 'Time to Response (TTR)', 'timeFrame': '5 years', 'description': "Time from the date of randomization to the date of a patient's first achieved a response of CR or PR on or after the Week 12 assessment"}, {'measure': 'SF-36v2', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in SF-36v2'}, {'measure': 'FACT-Lym', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in FACT-Lym'}, {'measure': 'EQ-VAS', 'timeFrame': '24 Months', 'description': 'Time to definitive deterioration in EQ-VAS'}, {'measure': 'Tisagenlecleucel Transgene Concentrations', 'timeFrame': '5 years', 'description': 'qPCR will be used to measure tisagenlecleucel transgene concentrations in peripheral blood and bone marrow'}, {'measure': 'Tisagenlecleucel Immunogenicity (Humoral and Cellular)', 'timeFrame': '5 years', 'description': 'Pre-existing and treatment related immunogenicity (humoral and cellular) of tisagenlecleucel will be characterized.'}, {'measure': 'Presence of Replication Competent Lentivirus (RCL)', 'timeFrame': '5 years', 'description': 'The presence of RCL will be assessed by VSV-qPCR in patients receiving tisagenlecleucel'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Non-Hodgkin's Lympoma", 'B-Cell Lymphoma', 'Diffuse Large B-cell Lymphoma', 'High Grade B-cell Lymphoma', 'Follicular Lymphoma grade 3B', 'CAR-T', 'Tisagenlecleucel', 'Kymriah', 'Immunotherapy', 'Cellular therapy', 'CTL019'], 'conditions': ['Non-Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34904798', 'type': 'DERIVED', 'citation': 'Bishop MR, Dickinson M, Purtill D, Barba P, Santoro A, Hamad N, Kato K, Sureda A, Greil R, Thieblemont C, Morschhauser F, Janz M, Flinn I, Rabitsch W, Kwong YL, Kersten MJ, Minnema MC, Holte H, Chan EHL, Martinez-Lopez J, Muller AMS, Maziarz RT, McGuirk JP, Bachy E, Le Gouill S, Dreyling M, Harigae H, Bond D, Andreadis C, McSweeney P, Kharfan-Dabaja M, Newsome S, Degtyarev E, Awasthi R, Del Corral C, Andreola G, Masood A, Schuster SJ, Jager U, Borchmann P, Westin JR. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):629-639. doi: 10.1056/NEJMoa2116596. Epub 2021 Dec 14.'}, {'pmid': '34515338', 'type': 'DERIVED', 'citation': 'Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.'}, {'pmid': '33288485', 'type': 'DERIVED', 'citation': 'Thiruvengadam SK, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34516954/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.', 'detailedDescription': 'Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed (Full analysis set): 162 subjects in the tisagenlecleucel arm and 160 subjects in the SOC arm.\n\nThe target population consisted of adult participants with aggressive B-cell non-Hodgkin lymphoma (NHL) who were relapsed/refractory within 365 days of their last dose of first line immunochemotherapy and eligible for autologous hematopoietic stem cell transplantation (HSCT).\n\nThe duration of treatment in the tisagenlecleucel treatment strategy is from the start of bridging chemotherapy (if applicable) until the infusion of tisagenlecleucel (expected on average at approximately 6 weeks from randomization). The duration of the treatment in the SOC treatment strategy is from the start of salvage chemotherapy until autologous HSCT. In either treatment arm, if infusion of tisagenlecleucel or autologous HSCT is not possible, the duration of treatment is until the last dose of study treatment prior to discontinuation of the treatment strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016):\n\n * DLBCL, NOS,\n * FL grade 3B,\n * Primary mediastinal large B cell lymphoma (PMBCL),\n * T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL),\n * DLBCL associated with chronic inflammation,\n * Intravascular large B-cell lymphoma,\n * ALK+ large B-cell lymphoma,\n * B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkin\'s Lymphoma (HL)),\n * High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,\n * High-grade B-cell lymphoma, NOS\n * HHV8+ DLBCL, NOS\n * DLBCL transforming from follicular lymphoma\n * DLBCL transforming from marginal zone lymphoma\n * DLBCL, leg type\n* Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR).\n* Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry\n* Disease that is both active on PET scan (defined as 5-Deauville scorepoint-scale of 4 or 5) and measurable on CT scan, defined as::\n\n * Nodal lesions \\>15 mm in the long axis, regardless of the length of the short axis, and/or\n * Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) \\>10 mm in long AND short axis\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ function:\n\nRenal function defined as:\n\n* Serum creatinine of ≤1.5 x upper limit of normal (ULN), OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2\n\nHepatic function defined as:\n\n* Alanine Transaminase (ALT) and Aspartate Transiminase (AST) ≤ 5 × ULN\n* Total bilirubin ≤ 1.5 x ULN with the exception of patients with Gilbert syndrome who may be included if their total bilirubin is ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN\n\nHematologic Function (regardless of transfusions) defined as:\n\n* Absolute neutrophil count (ANC) \\>1000/mm3\n* Absolute lymphocyte count (ALC) \\>300/mm3 OR Absolute number of CD3+ T cells \\>150/mm3 (only for patients with non-historical apheresis)\n* Platelets ≥50000/mm3\n* Hemoglobin \\>8.0 g/dl\n\nAdequate pulmonary function defined as:\n\n* No or mild dyspnea (≤ Grade 1)\n* Oxygen saturation measured by pulse oximetry \\> 90% on room air\n* Forced expiratory volume in 1 s (FEV1) ≥ 50% and/or carbon monoxide diffusion test (DLCO) ≥50% of predicted level - Must have a leukapheresis material of non-mobilized cells available for manufacturing.\n\nExclusion Criteria:\n\n* Prior treatment with anti-CD19 therapy, T cell therapy, or any prior gene therapy product\n* Treatment with any systemic lymphoma-directed second line anticancer therapy prior to randomization. Only steroids and local irradiation are permitted for disease control\n* Patients with active central nervous system (CNS) involvement by disease under study are excluded, except if the CNS involvement has been effectively treated and local treatment was \\>4 weeks before randomization\n* Prior allogeneic HSCT\n* Clinically significant active infection\n* Any of the following cardiovascular conditions:\n\n * Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening,\n * Left ventricle ejection fraction (LVEF) \\<45% as determined by echocardiogram (ECHO) or magnetic resonance angiography (MRA) or multigated acquisition (MUGA) at the screening assessment.\n * New York Heart Association (NYHA) functional class III or IV (Chavey et al 2001), within the past 12 months.\n * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II) and third degree AV block unless adequately controlled by pacemaker implantation.\n * Resting QTcF ≥450 msec (male) or ≥460 msec (female) at screening or inability to determine the QTcF interval\n * Risk factors for Torsades de Pointes (TdP), including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, or any of the following:\n * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome\n * Concomitant medication(s) with a "Known Risk of Torsades de Pointes" per crediblemeds.org that cannot be discontinued or replaced by safe alternative medication.\n* Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré Syndrome (GBS), Amyotrophic Lateral Sclerosis (ALS)) and clinically significant active cerebrovascular disorders (e.g. cerebral edema, posterior reversible encephalopathy syndrome (PRES))'}, 'identificationModule': {'nctId': 'NCT03570892', 'acronym': 'BELINDA', 'briefTitle': 'Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)', 'orgStudyIdInfo': {'id': 'CCTL019H2301'}, 'secondaryIdInfos': [{'id': '2016-002966-29', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508343-48-00', 'type': 'REGISTRY', 'domain': 'EU CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tisagenlecleucel treatment strategy', 'description': "Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel", 'interventionNames': ['Drug: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care treatment strategy', 'description': "Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)", 'interventionNames': ['Drug: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)']}], 'interventions': [{'name': 'Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy', 'type': 'DRUG', 'description': "Investigator's choice of optional platinum-based immunochemotherapy (ie. 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