Viewing Study NCT00557193

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Ignite Creation Date: 2025-12-25 @ 1:13 AM
Ignite Modification Date: 2026-02-24 @ 8:26 AM
Study NCT ID: NCT00557193
Status: COMPLETED
Last Update Posted: 2024-07-15
First Post: 2007-11-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], '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': 'D001215', 'term': 'Asparaginase'}, {'id': 'C001176', 'term': 'Leyk'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'C119379', 'term': 'lestaurtinib'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'C488629', 'term': 'azathiopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'C052932', 'term': 'exifone'}, {'id': 'C011906', 'term': 'Medrol Veriderm'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data was and never will be collected for Outcome Measure #4, 5, 12, and 13.'}}, 'adverseEventsModule': {'timeFrame': 'Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.', 'description': 'Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Induction (All Patients)', 'description': 'All Patients for Induction (not assigned)', 'otherNumAtRisk': 210, 'deathsNumAtRisk': 210, 'otherNumAffected': 181, 'seriousNumAtRisk': 210, 'deathsNumAffected': 6, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Post Induction (Follow-up Only)', 'description': 'Post-Induction patients that did not receive therapy', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 59, 'seriousNumAtRisk': 60, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 54, 'seriousNumAtRisk': 54, 'deathsNumAffected': 31, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Arm C (Safety/ Dose Level 1)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 6, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Arm C (Safety/ Dose Level 2)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 5, 'seriousNumAffected': 7}, {'id': 'EG006', 'title': 'Arm C (Efficacy/ Dose Level 2)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 55, 'seriousNumAtRisk': 56, 'deathsNumAffected': 28, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 32, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 58, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 69, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 40, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, 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'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 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disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Surgical and medical procedures - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Visceral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Safety/Efficacy Dose Level 2)', 'description': 'Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}], 'classes': [{'categories': [{'measurements': [{'value': '35.82', 'groupId': 'OG000', 'lowerLimit': '25.98', 'upperLimit': '45.66'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of post-induction therapy for up to 10 years', 'description': 'EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.', 'unitOfMeasure': 'percentage probability', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG001', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '38.89', 'groupId': 'OG000', 'lowerLimit': '27.98', 'upperLimit': '49.80'}, {'value': '35.82', 'groupId': 'OG001', 'lowerLimit': '25.98', 'upperLimit': '45.66'}]}]}], 'analyses': [{'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '85', 'paramValue': '1.107', 'ciUpperLimit': '1.403', 'pValueComment': 'A priori significance level threshold of alpha=0.15', 'estimateComment': 'Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio', 'groupDescription': 'A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\\<1.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of post-induction therapy for up to 10 years.', 'description': 'Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.', 'unitOfMeasure': 'percent probability', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)', 'description': 'Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL1 (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)'}, {'id': 'OG001', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)', 'description': 'Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks from start of induction', 'description': 'Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'timeFrame': 'Up to 12 weeks', 'description': 'Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was and never will be collected'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'timeFrame': 'Up to 12 weeks', 'description': 'Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was and never will be collected'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Safety/Efficacy Dose Level 2)', 'description': 'Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}], 'classes': [{'categories': [{'measurements': [{'value': '69.00', 'spread': '22.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sampled between weeks 6-12 from start of induction', 'description': 'Summarized with mean and standard deviation for those with available data in Arm C', 'unitOfMeasure': 'Activity percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm C Dose Level 2 (DL2) patients who had data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG001', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG002', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '7.85', 'spread': '10.65', 'groupId': 'OG001'}, {'value': '5.83', 'spread': '5.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sampled at the start of induction', 'description': 'Described via mean and standard deviation by group.', 'unitOfMeasure': 'qPCR fold expression ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected'}, {'type': 'SECONDARY', 'title': 'Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Safety/Efficacy Dose Level 2)', 'description': 'Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.73', 'spread': '4.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At relapse (up to 3 years)', 'description': 'Described via means and standard deviations in available Arm C relapse samples', 'unitOfMeasure': 'qPCR fold expression ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm C Dose Level 2 patients who relapsed and had data collected.'}, {'type': 'SECONDARY', 'title': 'Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG001', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG002', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Sampled at the start of induction', 'description': 'Described via means and standard deviations in samples which have primary resistance to lestaurtinib', 'unitOfMeasure': 'Proportion of cells that are viable', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected'}, {'type': 'SECONDARY', 'title': 'Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At relapse (up to 3 years)', 'description': 'Described via means and standard deviations in samples which have acquired resistance to lestaurtinib', 'unitOfMeasure': 'Proportion of cells that are viable', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm C Dose Level 2 patients who relapsed and had data collected'}, {'type': 'SECONDARY', 'title': 'Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (MRD Negative)', 'description': 'Arm A, standard risk MLL-G'}, {'id': 'OG001', 'title': 'Arm A (MRD Positive)', 'description': 'Arm A, standard risk MLL-G'}, {'id': 'OG002', 'title': 'Arm B (MRD Negative)', 'description': 'Arm B, IR/HR MLL-R chemotherapy'}, {'id': 'OG003', 'title': 'Arm B (MRD Positive)', 'description': 'Arm B, IR/HR MLL-R chemotherapy'}, {'id': 'OG004', 'title': 'Arm C (MRD Negative)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib'}, {'id': 'OG005', 'title': 'Arm C (MRD Positive)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib'}], 'classes': [{'categories': [{'measurements': [{'value': '86.05', 'groupId': 'OG000', 'lowerLimit': '77.36', 'upperLimit': '94.74'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '68.27', 'upperLimit': '100'}, {'value': '47.37', 'groupId': 'OG002', 'lowerLimit': '28.53', 'upperLimit': '66.21'}, {'value': '22.73', 'groupId': 'OG003', 'lowerLimit': '8.04', 'upperLimit': '37.42'}, {'value': '51.85', 'groupId': 'OG004', 'lowerLimit': '36.03', 'upperLimit': '67.67'}, {'value': '27.03', 'groupId': 'OG005', 'lowerLimit': '13.61', 'upperLimit': '40.45'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Years from end of Induction)', 'description': 'Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status.', 'unitOfMeasure': 'percent probability', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected'}, {'type': 'SECONDARY', 'title': 'Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG001', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG002', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'timeFrame': 'At 3 years', 'description': 'EFS outcomes will be reported by genotype.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was and never will never be collected.'}, {'type': 'SECONDARY', 'title': 'Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG001', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'OG002', 'title': 'Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'timeFrame': 'At 3 years', 'description': 'Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was and never will be collected'}, {'type': 'SECONDARY', 'title': 'Percent Probability for Event-free Survival (EFS) for Patients on Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '86.67', 'groupId': 'OG000', 'lowerLimit': '79.45', 'upperLimit': '93.89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of post-induction therapy for up to 10 years', 'description': 'EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.', 'unitOfMeasure': 'percentage probability', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Eligible patients treated in Arm A (standard risk MLL-G).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Induction (All Patients)', 'description': 'All Patients for Induction (not assigned).'}, {'id': 'FG001', 'title': 'Arm A (Standard Risk MLL-G)', 'description': 'Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'FG002', 'title': 'Arm B (IR/HR MLL-R Chemotherapy)', 'description': 'Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV'}, {'id': 'FG003', 'title': 'Arm C (Safety/ Dose Level 1)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)'}, {'id': 'FG004', 'title': 'ARM C (Safety/ Dose Level 2)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}, {'id': 'FG005', 'title': 'Arm C (Efficacy/ Dose Level 2)', 'description': 'Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)'}], 'periods': [{'title': 'Induction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Refusal of Further Protocol Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Inevaluable for post Induction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Unable to receive Lestaurtinib-Not in US', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Post Induction Therapy by Tx Assignment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Refusal of Further Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'Developed second malignant neoplasm', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Patient Moved to Another Institution', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Induction Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Infants with Acute Lymphoblastic Leukemia (ALL)', 'preAssignmentDetails': 'MLL-germline \\[G\\] to SR (Arm A/Group 1), MLL-rearranged \\[R\\] randomized/assigned to Arm B (Group2; chemo) or Arm C (Group3; chemo+lestaurtinib) with dose determined by age at dx (\\>=90 days is IR and \\<90 days is HR)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients for Induction'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '218', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '167', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-04-05', 'size': 5873459, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-19T18:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2007-11-09', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-13', 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)', 'timeFrame': 'From start of post-induction therapy for up to 10 years', 'description': 'EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.'}], 'secondaryOutcomes': [{'measure': 'Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2', 'timeFrame': 'From start of post-induction therapy for up to 10 years.', 'description': 'Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.'}, {'measure': 'Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)', 'timeFrame': 'Up to 12 weeks from start of induction', 'description': 'Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.'}, {'measure': 'Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'timeFrame': 'Up to 12 weeks', 'description': 'Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.'}, {'measure': 'Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'timeFrame': 'Up to 12 weeks', 'description': 'Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.'}, {'measure': 'Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy', 'timeFrame': 'Sampled between weeks 6-12 from start of induction', 'description': 'Summarized with mean and standard deviation for those with available data in Arm C'}, {'measure': 'Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts', 'timeFrame': 'Sampled at the start of induction', 'description': 'Described via mean and standard deviation by group.'}, {'measure': 'Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts', 'timeFrame': 'At relapse (up to 3 years)', 'description': 'Described via means and standard deviations in available Arm C relapse samples'}, {'measure': 'Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts', 'timeFrame': 'Sampled at the start of induction', 'description': 'Described via means and standard deviations in samples which have primary resistance to lestaurtinib'}, {'measure': 'Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts', 'timeFrame': 'At relapse (up to 3 years)', 'description': 'Described via means and standard deviations in samples which have acquired resistance to lestaurtinib'}, {'measure': 'Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm', 'timeFrame': '3 Years from end of Induction)', 'description': 'Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status.'}, {'measure': 'Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes', 'timeFrame': 'At 3 years', 'description': 'EFS outcomes will be reported by genotype.'}, {'measure': 'Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values', 'timeFrame': 'At 3 years', 'description': 'Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype'}, {'measure': 'Percent Probability for Event-free Survival (EFS) for Patients on Arm A', 'timeFrame': 'From start of post-induction therapy for up to 10 years', 'description': 'EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Acute Undifferentiated Leukemia', 'Childhood T Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '32414848', 'type': 'DERIVED', 'citation': 'Loftus JP, Yahiaoui A, Brown PA, Niswander LM, Bagashev A, Wang M, Schauf A, Tannheimer S, Tasian SK. Combinatorial efficacy of entospletinib and chemotherapy in patient-derived xenograft models of infant acute lymphoblastic leukemia. Haematologica. 2021 Apr 1;106(4):1067-1078. doi: 10.3324/haematol.2019.241729.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the 3-year event-free survival (EFS) of infants with mixed lineage leukemia-rearranged (MLL-R) acute lymphoblastic leukemia (ALL) treated with chemotherapy plus the fms-related tyrosine kinase 3 (FLT3) inhibitor lestaurtinib.\n\nSECONDARY OBJECTIVES:\n\nI. To compare the 3-year EFS of infants with MLL-R ALL treated with chemotherapy plus the FLT3 inhibitor lestaurtinib to MLL-R patients treated with chemotherapy alone.\n\nII. To determine a safe, tolerable and biologically active dose of lestaurtinib given in sequential combination with chemotherapy in MLL-R infants.\n\nIII. To characterize the pharmacokinetics and pharmacodynamics of lestaurtinib in infants when given at the proposed dose in sequential combination with chemotherapy.\n\nIV. To identify molecular mechanisms of resistance to lestaurtinib in leukemic blasts.\n\nV. To describe levels of minimal residual disease in infants with ALL within the context of the proposed therapy, and correlate with outcome.\n\nVI. To identify gene expression patterns in diagnostic infant leukemia samples that correlate with outcome within the context of the proposed therapy.\n\nVII. To describe the outcome of infants with MLL-G ALL treated with a modified P9407 chemotherapy backbone that includes an extended continuation phase.\n\nOUTLINE:\n\nINDUCTION THERAPY (WEEKS 1-5): All patients receive induction therapy comprising vincristine sulfate intravenously (IV) over 1 minute on days 8, 15, 22, and 29; daunorubicin hydrochloride IV over 30 minutes on days 8 and 9; cyclophosphamide IV over 30 minutes every 12 hours on days 3 and 4 (closed as of 05/19/09); pegaspargase or asparaginase intramuscularly (IM) on days 15, 18, 22, 25, 29, and 33; prednisone orally (PO) thrice daily (TID) or methylprednisolone IV on days 1-7; dexamethasone IV or PO TID on days 8-28; cytarabine IV over 30 minutes on days 8-21; methotrexate intrathecally (IT) on days 1 and 29; cytarabine IT on day 15; hydrocortisone IT on days 15 and 29; and filgrastim IV or subcutaneously (SC) beginning on day 5 and continuing until blood counts recover. Standard-risk patients are non-randomly assigned to receive a less intensive chemotherapy regimen without lestaurtinib (post-induction therapy A). Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), blood sample collection and bone marrow biopsy on day 1 week 1.\n\nPOST-INDUCTION THERAPY A: (for standard-risk patients MLL-germline \\[G\\])\n\nINDUCTION INTENSIFICATION (WEEKS 6-9): Patients receive high-dose methotrexate IV continuously over 24 hours on days 1 and 8; triple IT chemotherapy comprising methotrexate, cytarabine, and hydrocortisone on days 1 and 8; leucovorin calcium IV or PO every 6 hours beginning 42 hours after start of high-dose methotrexate and continuing until methotrexate level is \\< 0.1 uM; cyclophosphamide IV over 30 minutes on days 15-19; etoposide IV over 2 hours on days 15-19; and filgrastim IV or SC beginning on day 20 and continuing until blood counts recover. Patients in morphologic remission proceed to re-induction therapy. Patients may undergo bone marrow biopsy on day 1 week 6.\n\nRE-INDUCTION (WEEKS 10-12): Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15; daunorubicin hydrochloride IV over 30 minutes on days 1 and 2; cyclophosphamide IV over 30 minutes every 12 hours on days 3 and 4; pegaspargase or asparaginase IM on day 4; dexamethasone IV or PO twice daily (BID) on days 1-7 and 15-21; triple IT chemotherapy comprising methotrexate, cytarabine, and hydrocortisone on days 1 and 15; and filgrastim IV or SC beginning on day 5 and continuing until blood counts recover. Patients undergo ECHO or MUGA, blood sample collection and bone marrow biopsy on day 1 week 10.\n\nCONSOLIDATION (WEEKS 13-19): Patients receive high-dose methotrexate IV continuously over 24 hours on days 1 and 8; leucovorin calcium IV every 6 hours beginning 42 hours after start of high-dose methotrexate and continuing until methotrexate level is \\< 0.1 uM; triple IT chemotherapy comprising methotrexate, cytarabine, and hydrocortisone on day 1; etoposide IV over 2 hours on days 15-19; cyclophosphamide IV over 30 minutes on days 15-19; high-dose cytarabine IV over 3 hours every 12 hours on days 29 and 30; pegaspargase or asparaginase IM on day 30; and filgrastim IV or SC beginning on day 20 and day 31 and continuing until blood counts recover.\n\nCONTINUATION I (WEEKS 20-41): Patients receive vincristine sulfate IV on day 1 in weeks 20 and 24; dexamethasone IV or PO BID on days 1-5 in weeks 20, and 24; triple IT chemotherapy comprising methotrexate, cytarabine, and hydrocortisone on day 1 in weeks 20 and 24; methotrexate IV on day 1 in weeks 21-24 and 25-27; etoposide IV over 2 hours on day 1-5 in week 28; cyclophosphamide IV over 30 minutes on days 1-5 in week 28; mercaptopurine PO on days 1-7 in weeks 21-23 and 25-27; and filgrastim SC or IV beginning on day 6 in week 28 and continuing until blood counts recover. Patients may undergo bone marrow biopsy on day 1 week 20.\n\nCONTINUATION II (WEEKS 42-104): Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone IV or PO BID on days 1-5, 29-33, and 57-61; methotrexate IT on day 1; methotrexate PO on days 8, 15, 22, 36, 43, 50, 64, 71, and 78; and mercaptopurine PO on days 8-28, 36-56, and 64-84. Treatment repeats every 12 weeks for 2 years from diagnosis.\n\nA safety/activity phase is conducted separately for the intermediate-risk (IR) and high-risk (HR) patients to identify a safe, tolerable, and biologically active dose of lestaurtinib combined with chemotherapy backbone. Once a tolerable/active dose of lestaurtinib has been identified for IR patients, subsequent IR patients are eligible to proceed to an efficacy phase, where they are randomized (or non-randomly assigned as of 7/16/2014) to chemotherapy with or without lestaurtinib. HR patients separately proceed to the randomized efficacy phase if a tolerable/active dose is identified for the HR stratum. IR and HR patients are randomized (or non-randomly assigned as of 7/16/2014) to 1 of 2 post-induction therapy regimens (post-induction therapy B or C).\n\nPOST-INDUCTION THERAPY B: (chemotherapy only for IR/HR patients classified as MLL-R; age \\>= 90 days at diagnosis):\n\nINDUCTION INTENSIFICATION (WEEKS 6-9): Patients receive high-dose methotrexate, leucovorin calcium, cyclophosphamide, etoposide, and filgrastim as in post-induction therapy A induction intensification. Patients in morphologic remission proceed to re-induction Patients undergo ECHO or MUGA, blood sample collection and bone marrow biopsy on day 1 week 6. (Retired as of 7/16/2014)\n\nRE-INDUCTION (WEEKS 10-12): Patients receive vincristine sulfate, daunorubicin hydrochloride, cyclophosphamide, pegaspargase or asparaginase, dexamethasone, triple IT chemotherapy, and filgrastim as in post-induction therapy A re-induction. Patients undergo ECHO or MUGA, blood sample collection and bone marrow biopsy on day 1 week 10. (Retired as of 7/16/2014)\n\nCONSOLIDATION (WEEKS 13-19): Patients receive high-dose methotrexate, leucovorin calcium, triple IT chemotherapy, etoposide, cyclophosphamide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy A consolidation. (Retired as of 7/16/2014)\n\nCONTINUATION I (WEEKS 20-49): Patients receive vincristine sulfate IV over 1 minute on day 1 in weeks 20, 24, 33, 37, and 46; dexamethasone PO or IV BID on days 1-5 in weeks 20, 24, 33, 37, and 46; triple IT chemotherapy on day 1 in weeks 20, 24, 33, 37, and 46; methotrexate IV on day 1 in weeks 21-23, 25-26 and 37-45; mercaptopurine PO on days 1-7 in weeks 21-23, 25-26 and 37-45; etoposide IV over 2 hours on days 1-5 in week 27; cyclophosphamide IV over 2 hours on days 1-5 in week 27: high-dose cytarabine IV over 3 hours every 12 hours on days 1 and 2 in week 30; pegaspargase or asparaginase IM on day 2 in week 30: and filgrastim SC or IV beginning on day 3 in weeks 30 and continuing until blood counts recover. Patients may undergo bone marrow biopsy on day 1 of weeks 20, 33 and 46. (Retired as of 7/16/2014)\n\nCONTINUATION II (WEEKS 50-104): Patients receive vincristine sulfate, dexamethasone, IT methotrexate, methotrexate PO, and mercaptopurine PO as in post-induction therapy A continuation II. Treatment repeats every 12 weeks for 2 years from diagnosis. (Retired as of 7/16/2014)\n\nPOST-INDUCTION THERAPY C: (chemotherapy and lestaurtinib for IR/HR patients classified as MLL-R; age \\< 90 days at diagnosis)\n\nINDUCTION INTENSIFICATION THERAPY (WEEKS 6-9): Patients receive high-dose methotrexate, leucovorin calcium, cyclophosphamide, etoposide, and filgrastim as in post-induction therapy B induction intensification. Patients also receive lestaurtinib PO BID on days 20-27. Patients in morphologic remission proceed to re-induction.Patients undergo ECHO or MUGA, blood sample collection and bone marrow biopsy on day 1 week 6.\n\nRE-INDUCTION (WEEKS 10-12): Patients receive vincristine sulfate, daunorubicin hydrochloride, cyclophosphamide, pegaspargase or asparaginase, dexamethasone, triple IT chemotherapy, and filgrastim as in post-induction therapy B re-induction. Patients also receive lestaurtinib PO on days 5-20. Patients undergo ECHO or MUGA, blood sample collection and bone marrow biopsy on day 1 week 10.\n\nCONSOLIDATION (WEEKS 13-19) Patients receive high-dose methotrexate, leucovorin calcium, triple IT chemotherapy, etoposide, cyclophosphamide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy B consolidation. Patients also receive lestaurtinib PO on days 20-27 and 31-42.\n\nCONTINUATION I (WEEKS 20-49): Patients receive vincristine sulfate, dexamethasone, triple IT chemotherapy, methotrexate, mercaptopurine, etoposide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy B continuation I. Patients also receive lestaurtinib PO on days 2-6 in weeks 20 and 24; days 27-41 in weeks 27-29; days 45-56 in weeks 30-32. Patients may undergo bone marrow biopsy on day 1 of weeks 20, 33 and 46.\n\nCONTINUATION II (WEEKS 50-104): Patients receive vincristine sulfate, dexamethasone, IT methotrexate, methotrexate PO, and mercaptopurine PO as in post-induction therapy B continuation II. Treatment repeats every 12 weeks for 2 years from diagnosis.\n\nAfter completion of study treatment, all patients are followed up every 1-6 months for 4 years and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be enrolled on a Children's Oncology Group (COG) ALL Classification Study (AALL08B1) prior to enrollment on AALL0631\n* Patients must be \\< 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be \\> 36 weeks gestational age at the time of diagnosis\n* Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL); patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid\n* Patients must be previously untreated with the exception of steroids and intrathecal chemotherapy; no other systemic chemotherapy may have been administered; patients receiving prior steroid therapy are eligible for study; any amount of steroid pretreatment will not affect initial induction assignment as long as the patient meets all other eligibility criteria; IT chemotherapy per protocol is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture; (note: the central nervous system \\[CNS\\] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n* Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible\n* Patients with Down syndrome are NOT eligible"}, 'identificationModule': {'nctId': 'NCT00557193', 'briefTitle': 'Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)', 'orgStudyIdInfo': {'id': 'AALL0631'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00313', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000573996'}, {'id': '08-146'}, {'id': 'COG-AALL0631'}, {'id': 'AALL0631', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AALL0631', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (standard risk MLL-G)', 'description': 'Population Description: Eligible patients with MLL-G (germline, or non-rearranged)', 'interventionNames': ['Drug: Asparaginase', 'Procedure: Biospecimen Collection', 'Procedure: Bone Marrow Biopsy', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Dexamethasone', 'Procedure: Echocardiography', 'Drug: Etoposide', 'Biological: Filgrastim', 'Other: Laboratory Biomarker Analysis', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Methylprednisolone', 'Procedure: Multigated Acquisition Scan', 'Drug: Pegaspargase', 'Other: Pharmacological Study', 'Drug: Prednisone', 'Drug: Therapeutic Hydrocortisone', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B (IR/HR MLL-R chemotherapy)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.', 'interventionNames': ['Drug: Asparaginase', 'Procedure: Biospecimen Collection', 'Procedure: Bone Marrow Biopsy', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Dexamethasone', 'Procedure: Echocardiography', 'Drug: Etoposide', 'Biological: Filgrastim', 'Other: Laboratory Biomarker Analysis', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Methylprednisolone', 'Procedure: Multigated Acquisition Scan', 'Drug: Pegaspargase', 'Other: Pharmacological Study', 'Drug: Prednisone', 'Drug: Therapeutic Hydrocortisone', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)', 'description': 'Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.', 'interventionNames': ['Drug: Asparaginase', 'Procedure: Biospecimen Collection', 'Procedure: Bone Marrow Biopsy', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Dexamethasone', 'Procedure: Echocardiography', 'Drug: Etoposide', 'Biological: Filgrastim', 'Other: Laboratory Biomarker Analysis', 'Drug: Lestaurtinib', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Methylprednisolone', 'Procedure: Multigated Acquisition Scan', 'Drug: Pegaspargase', 'Other: Pharmacological Study', 'Drug: Prednisone', 'Drug: Therapeutic Hydrocortisone', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': 'Asparaginase', 'type': 'DRUG', 'otherNames': ['ASP-1', 'Asparaginase II', 'Asparaginase-E.Coli', 'Colaspase', 'Elspar', 'Kidrolase', 'L-Asnase', 'L-ASP', 'L-Asparaginase', 'L-Asparagine Amidohydrolase', 'Laspar', 'Lcf-ASP', 'Leucogen', 'Leunase', 'MK-965', 'Paronal', 'Re-82-TAD-15', 'Serasa', 'Spectrila'], 'description': 'Given IV, IM, or PO', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Bone Marrow Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy of Bone Marrow', 'Biopsy, Bone Marrow'], 'description': 'Undergo bone marrow biopsy', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Asta B 518', 'B 518', 'B-518', 'B518', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR 138719', 'WR- 138719', 'WR-138719', 'WR138719'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-Cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IV or IT', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Daunorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['Cerubidin', 'Cerubidine', 'Cloridrato de Daunorubicina', 'Daunoblastin', 'Daunoblastina', 'Daunoblastine', 'Daunomycin Hydrochloride', 'Daunomycin, hydrochloride', 'Daunorubicin.HCl', 'Daunorubicini Hydrochloridum', 'FI-6339', 'Ondena', 'RP-13057', 'Rubidomycin Hydrochloride', 'Rubilem'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycadron', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decadron DP', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasone Intensol', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Dxevo', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hemady', 'Hexadecadrol', 'Hexadrol', 'LenaDex', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'TaperDex', 'Visumetazone', 'ZoDex'], 'description': 'Given IV or PO', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Echocardiography', 'type': 'PROCEDURE', 'otherNames': ['EC'], 'description': 'Undergo ECHO', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP 16213', 'VP-16', 'VP-16-213', 'VP-16213', 'VP16', 'VP16213'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Filgrastim Biosimilar Filgrastim-sndz', 'Filgrastim Biosimilar Tbo-filgrastim', 'Filgrastim XM02', 'Filgrastim-aafi', 'Filgrastim-ayow', 'Filgrastim-sndz', 'G-CSF', 'Granix', 'Neupogen', 'Neutroval', 'Nivestim', 'Nivestym', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'Releuko', 'rG-CSF', 'Tbo-filgrastim', 'Tevagrastim', 'XM02', 'Zarxio'], 'description': 'Given IV or SC', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Lestaurtinib', 'type': 'DRUG', 'otherNames': ['CEP 701', 'CEP-701', 'CEP701', 'KT-5555', 'SPM-924'], 'description': 'Given PO', 'armGroupLabels': ['Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Leucovorin Calcium', 'type': 'DRUG', 'otherNames': ['Adinepar', 'Calcifolin', 'Calcium (6S)-Folinate', 'Calcium Folinate', 'Calcium Leucovorin', 'Calfolex', 'Calinat', 'Cehafolin', 'Citofolin', 'Citrec', 'Citrovorum Factor', 'Cromatonbic Folinico', 'Dalisol', 'Disintox', 'Divical', 'Ecofol', 'Emovis', 'Factor, Citrovorum', 'Flynoken A', 'Folaren', 'Folaxin', 'FOLI-cell', 'Foliben', 'Folidan', 'Folidar', 'Folinac', 'Folinate Calcium', 'folinic acid', 'Folinic Acid Calcium Salt Pentahydrate', 'Folinoral', 'Folinvit', 'Foliplus', 'Folix', 'Imo', 'Lederfolat', 'Lederfolin', 'Leucosar', 'leucovorin', 'Rescufolin', 'Rescuvolin', 'Tonofolin', 'Wellcovorin'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'otherNames': ['3H-Purine-6-thiol', '6 MP', '6 Thiohypoxanthine', '6 Thiopurine', '6-Mercaptopurine', '6-Mercaptopurine Monohydrate', '6-MP', '6-Purinethiol', '6-Thiopurine', '6-Thioxopurine', '6H-Purine-6-thione, 1,7-dihydro- (9CI)', '7-Mercapto-1,3,4,6-tetrazaindene', 'Alti-Mercaptopurine', 'Azathiopurine', 'Bw 57-323H', 'Flocofil', 'Ismipur', 'Leukerin', 'Leupurin', 'Mercaleukim', 'Mercaleukin', 'Mercaptina', 'Mercaptopurinum', 'Mercapurin', 'Mern', 'NCI-C04886', 'Puri-Nethol', 'Purimethol', 'Purine, 6-mercapto-', 'Purine-6-thiol (8CI)', 'Purine-6-thiol, monohydrate', 'Purinethiol', 'Purinethol', 'U-4748', 'WR-2785'], 'description': 'Given PO', 'armGroupLabels': ['Arm A (standard risk MLL-G)', 'Arm B (IR/HR MLL-R chemotherapy)', 'Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abitrexate', 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