Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT03817320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2019-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548400', 'term': 'ixazomib'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D003067', 'term': 'Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TACL@chla.usc.edu', 'phone': '3233615429', 'title': 'TACL', 'organization': 'TACL'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)', 'description': 'No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Ixazomib Dose Level 1 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. . Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 3, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Ixazomib Dose Level 1 (Stratum B)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bleeding labial skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Buttock Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Mottled Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Decreased Respiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, 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'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}], 'seriousEvents': [{'term': 'Abominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Adult Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Edema Cerebral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'GGT Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixazomib Dose Level 1 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'OG001', 'title': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 weeks', 'description': 'The incidence of dose limiting toxicity (DLT) will be measured only during block 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with Down Syndrome enrolled in Ixazomib Dose Level 1 (Stratum B) are not eligible for inclusion in the primary DLT or response evaluation. Only the first 6 patients enrolled in Dose Level 2 Stratum A were part of the Phase I portion of this study.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Block 1 treatment, Day 29-35 of treatment, assessed within 35 days from treatment start', 'description': 'The count of participants below represents the number of patients who achieved CR MRD- or CRi MRD- at the end of block 1 treatment and treated at RP2D (recommended phase 2 dose).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixazomib Dose Level 1 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'FG001', 'title': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'FG002', 'title': 'Ixazomib Dose Level -1 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'FG003', 'title': 'Ixazomib Dose Level 1 (Stratum B)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixazomib Dose Level 1 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'BG001', 'title': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Block 1 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 2 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'BG002', 'title': 'Ixazomib Dose Level 1 (Stratum B)', 'description': "Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\\^2 on Day 2. Doxorubicin at 60 mg/m\\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.\n\nBlock 2 - Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\\^2 OR Calaspargase IV 2500 IU/m\\^2 on Day 9. Methotrexate IV 1000 mg/m\\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Zero patients enrolled on Dose Level -1 of Stratum A as the Dose Level 1 and 2 were deemed safe in Phase I of the study. Dose Level 2 was used as the dose expansion for Phase II. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-07', 'size': 2096552, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-11-12T17:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2019-01-22', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-30', 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy', 'timeFrame': '5 weeks', 'description': 'The incidence of dose limiting toxicity (DLT) will be measured only during block 1'}, {'measure': 'Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D', 'timeFrame': 'End of Block 1 treatment, Day 29-35 of treatment, assessed within 35 days from treatment start', 'description': 'The count of participants below represents the number of patients who achieved CR MRD- or CRi MRD- at the end of block 1 treatment and treated at RP2D (recommended phase 2 dose).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALL, Childhood', 'Lymphoblastic Lymphoma, Childhood', 'Lymphoblastic Leukemia, Acute, Childhood']}, 'descriptionModule': {'briefSummary': 'This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).', 'detailedDescription': 'The phase 1 study is to determine the maximum tolerated dose (MTD) of the PO formulation, followed by a screening phase 2 study to investigate the efficacy of ixazomib in combination with chemotherapy in children with relapsed ALL and lymphoblastic lymphoma (LLy). The single arm, screening phase 2 design will allow us to use a minimal number of patients to obtain preliminary information about treatment efficacy. Discovering a safe and tolerable dose of ixazomib in a PO formulation and the preliminary efficacy data will significantly increase the possibility of ixazomib moving forward in frontline pediatric treatment protocols in both intense chemotherapy courses and maintenance courses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age Patients must be ≤21 years of age at the time of enrollment.\n\n 1. Phase 1 - Initial enrollment will be restricted to patients \\< 18 years of age until 9 such patients are enrolled\n 2. Phase 2 - Initial enrollment will be restricted to patients \\< 18 years of age until 6 such patients are enrolled (applies to Stratum A only)\n* Diagnosis Patients must have a diagnosis of relapsed/refractory ALL or LLy with or without extramedullary disease (including CNS2 and CNS3). Patient with mixed phenotype ALL or mature B (Burkitt-like) leukemia are not eligible.\n\n 1. Patients with ALL must have ≥ 5% blasts by morphology.\n 2. Patients with LLy must have measurable disease documented by clinical, radiologic or histologic criteria\n* Performance Level Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50% for patients ≤ 16 years of age.\n* Prior Therapy A. Prior therapeutic attempts\n\n * Phase 1 - Any patients with relapsed/refractory ALL or LLy\n * Phase 2\n\n 1. B-cell ALL/LLy: all patients must have failed two or more therapeutic attempts.\n 2. T-cell ALL/LLy: all patients must have failed one or more therapeutic attempts. B. Recent prior chemotherapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n * Myelosuppressive chemotherapy: At least 14 days must have elapsed since the completion of myelosuppressive therapy. However, patients may receive any of the following medications within 14 days without a "wash-out" period:\n* Hydroxyurea: Hydroxyurea can be initiated and/or continued for up to 24 hours prior to the start of protocol therapy.\n\n * "Maintenance-style" therapy - Therapy including vincristine (dosed at a maximum of one-time weekly), oral 6-mercaptopurine, oral methotrexate (dosed at a maximum of one-time weekly), dexamethasone (dosed at ≤ 3 mg\\*/m\\^2/dose twice daily), and prednisone (dosed at ≤ 20 mg\\*/m\\^2/dose twice daily) can be initiated and/or continued for up to 24 hours prior to the start of protocol therapy.\n\n * Doses can be rounded to adjust for pill size\n\nC. Hematopoietic stem cell transplant: Patients who have experienced their relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days post-transplant at the time of enrollment.\n\nD. Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with G-CSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with long-acting filgrastim (pegfilgrastim or biosimilar)\n\nE. Biologic (anti-neoplastic agent): At least 7 days since the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair\n\n1. Monoclonal antibodies: At least 3 half-lives of the antibody or 21 days (whichever is shorter) must have elapsed after the last dose of monoclonal antibody. (i.e., blinatumomab half-life = 6 hours, therefore washout is 18 hours; inotuzumab half-life = 37 days therefore washout is 21 days; rituximab half-life = 66 days, therefore washout is 21 days). If steroids are being used to modify immune-related adverse events of antibody therapy, at least 14 days must have elapsed since the last dose of corticosteroid.\n2. Immunotherapy: At least 30 days after the completion of any type of immunotherapy, e.g., tumor vaccines, CAR T cells. If steroids are being used to modify immune-related adverse events of immunotherapy, at least 14 days must have elapsed since the last dose of corticosteroid.\n\nF. XRT: Craniospinal XRT is prohibited during protocol therapy. No washout period is necessary for radiation given to any extramedullary site other than CNS; ≥90 days must have elapsed if prior total body irradiation (TBI) or craniospinal XRT.\n\nG. Anthracyclines: Patients must have had a lifetime exposure of \\<400 mg/m\\^2 of doxorubicin equivalents of anthracyclines.\n\nH. Proteasome inhibitors: Patients with a prior exposure to proteasome inhibitors (e.g., bortezomib, carfilzomib) are eligible as long as the patient demonstrated at least a partial response to a proteasome inhibitor with chemotherapy combination. This criteria only applies to the Phase 2 portion of the study.\n\n-Renal and hepatic function\n\nPatients must have adequate renal and hepatic functions as indicated by the following laboratory values:\n\nA. Adequate renal function defined as: Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m\\^2 OR a normal serum creatinine based on age/gender\n\nB. Adequate Liver Function Defined as: Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) for age or normal (except in the presence of Gilbert\'s syndrome), AND alanine transaminase (ALT) ≤ 5 x ULN for age. The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia or lymphoma. This must be reviewed by and approved by the study chair or vice chair.\n\n* Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% by echocardiogram, OR ejection fraction of ≥ 50% by radionuclide angiogram (MUGA).\n* Reproductive Function A. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n\nB. Female patients with infants must agree not to breastfeed their infants while on this study.\n\nC. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.\n\n* Informed Consent Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent. Age appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible.\n* All institutional, FDA, and OHRP requirements for human studies must be met.\n\nExclusion Criteria:\n\nPatients will be excluded if they have isolated CNS or testicular disease.\n\nPatients will be excluded if they have ≥ grade 2 peripheral sensory or motor neuropathy (defined by the Modified "Balis" Pediatric Scale of Pediatric Neuropathies) at the time of enrollment.\n\nPatients will be excluded if they have a known allergy or intolerance to any of the drugs used in the study - except for Pegaspargase for which asparaginase Erwinia chrysanthemi (recombinant)-rywn (Rylaze®) or (if available) crisantaspase (Erwinase®), may be substituted for allergy to Pegaspargase\n\nPatients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.\n\nPatients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.\n\nPatients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n\nPatients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.\n\nPatients will be excluded if they have had a lifetime exposure of ≥400 mg/m2 doxorubicin equivalents of anthracyclines (anthracycline equivalence to doxorubicin conversion see appendix iv) .\n\nConcomitant medications Investigational drugs: Patients currently receiving another investigational drug are not eligible.\n\nAnti-GVHD agents post transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post hematopoetic stem cell transplant are not eligible.\n\nCYP3A4 agents: patients who are currently receiving drugs that are strong inducers of CYP3A4 are not eligible.\n\nPatients with Ph+ALL and Ph-like ALL who are currently receiving TKI therapy'}, 'identificationModule': {'nctId': 'NCT03817320', 'briefTitle': 'PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Therapeutic Advances in Childhood Leukemia Consortium'}, 'officialTitle': 'A TACL Phase 1/2 Study of PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma IND# 140730', 'orgStudyIdInfo': {'id': 'T2017-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixazomib Dose Level 1 (Stratum A)', 'description': "Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15, Doxorubicin at 60 mg/m\\^2 on Days 1, Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.", 'interventionNames': ['Drug: Ixazomib', 'Drug: Vincristine', 'Drug: Dexamethasone', 'Drug: Asparaginase', 'Drug: Doxorubicin', 'Drug: Methotrexate (IT)', 'Drug: Triple IT (Methotrexate, Hydrocortisone, Cytarabine)']}, {'type': 'EXPERIMENTAL', 'label': 'Ixazomib Dose Level 2 (Stratum A)', 'description': "Patients will be treated on ixazomib at 2.0 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15, Doxorubicin at 60 mg/m\\^2 on Days 1, Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. Patients will be treated at this arm Dose Level once patient accrual at Dose Level 1 has been completed and dose escalation is allowed as defined by the 3+3 design.", 'interventionNames': ['Drug: Ixazomib', 'Drug: Vincristine', 'Drug: Dexamethasone', 'Drug: Asparaginase', 'Drug: Doxorubicin', 'Drug: Methotrexate (IT)', 'Drug: Triple IT (Methotrexate, Hydrocortisone, Cytarabine)']}, {'type': 'EXPERIMENTAL', 'label': 'Ixazomib Dose Level -1 (Stratum A)', 'description': "Patients will be treated on ixazomib at 1.2 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15, Doxorubicin at 60 mg/m\\^2 on Days 1, Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm Dose Level -1 is needed only if de-escalation from Dose Level 1 is required.", 'interventionNames': ['Drug: Ixazomib', 'Drug: Vincristine', 'Drug: Dexamethasone', 'Drug: Asparaginase', 'Drug: Doxorubicin', 'Drug: Methotrexate (IT)', 'Drug: Triple IT (Methotrexate, Hydrocortisone, Cytarabine)']}, {'type': 'EXPERIMENTAL', 'label': 'Ixazomib Dose Level 1 (Stratum B)', 'description': "Patients will be treated on ixazomib at 1.6 mg/m\\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\\^2 on Days 2 and 15, Doxorubicin at 60 mg/m\\^2 on Days 1, Dexamethasone IV/PO at 10 mg/m\\^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. Leucovorin PO/IV at 5 mg/m\\^2/dose X 2 doses given 24 and 30 hours after IT Methotrexate or Triple IT will also be given on this arm. This arm is only for patients with Down syndrome (Stratum B).", 'interventionNames': ['Drug: Ixazomib', 'Drug: Vincristine', 'Drug: Dexamethasone', 'Drug: Asparaginase', 'Drug: Doxorubicin', 'Drug: Methotrexate (IT)', 'Drug: Triple IT (Methotrexate, Hydrocortisone, Cytarabine)', 'Drug: Leucovorin']}], 'interventions': [{'name': 'Ixazomib', 'type': 'DRUG', 'description': 'Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses\n\nDose Phase 1 - Assigned upon study entry.\n\nPhase 2 - PO formulation at RP2D', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'IV push over 1 minute or infusion via minibag as per institutional policy\n\nDays 1, 8, 15 and 22\n\nDose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)\n\n≥ 6 months and \\< 1 year: 1.2mg/m2/dose\n\n\\< 6 months: 1mg/m2/dose', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Days 1-14\n\nDose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)\n\n≥ 6 months and \\< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)\n\n\\< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Asparaginase', 'type': 'DRUG', 'description': 'Days 2, 15\n\nDose ≥ 1 year: 2,500 International units (IU)/m2/dose\n\n≥ 6 months and \\< 1 year: 2,000 IU/m2/dose\n\n\\< 6 months: 1,750 IU/m2/dose\n\nPatient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase.\n\nDosing guideline for Erwinase:\n\n* 1 year: 25,000 IU/m2/dose\n* 6 months and \\< 1 year: 20,000 IU/m2/dose\n\n\\< 6 months: 17,500 IU/m2/dose', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Day 1\n\nDose ≥ 1 year: 60mg/m2/dose\n\n≥ 6 months and \\< 1 year: 48 mg/m2/dose\n\n\\< 6 months: 42mg/m2/dose', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Methotrexate (IT)', 'type': 'DRUG', 'description': 'For patients with CNS 1 or CNS 2, on Days 1, 15, and 29', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Triple IT (Methotrexate, Hydrocortisone, Cytarabine)', 'type': 'DRUG', 'description': 'For patients with CNS 3, on Days 1, 8, 15, 22, and 29', 'armGroupLabels': ['Ixazomib Dose Level -1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum A)', 'Ixazomib Dose Level 1 (Stratum B)', 'Ixazomib Dose Level 2 (Stratum A)']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'For patients with Down syndrome only, on Days 2, 9, 16, 23, and 30 (based on dates when IT Methotrexate or Triple IT is given)', 'armGroupLabels': ['Ixazomib Dose Level 1 (Stratum B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospital and Clinics of Minnesota", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Seidman Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Doernbecher Children's Hospital", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital/Baylor University", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}], 'overallOfficials': [{'name': 'Terzah Horton, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therapeutic Advances in Childhood Leukemia Consortium', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}