Viewing Study NCT00408005

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Ignite Creation Date: 2025-12-25 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:50 AM
Study NCT ID: NCT00408005
Status: COMPLETED
Last Update Posted: 2025-04-20
First Post: 2006-12-04
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'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': '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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'C488629', 'term': 'azathiopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}, {'id': 'C104457', 'term': 'nelarabine'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D013866', 'term': 'Thioguanine'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'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': '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': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'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': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of Induction therapy to end of Maintenance therapy, up to 10 years', 'description': 'Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'T-ALL Induction Therapy', 'description': 'All patients diagnosed as T-ALL for induction', 'otherNumAtRisk': 1563, 'deathsNumAtRisk': 1563, 'otherNumAffected': 983, 'seriousNumAtRisk': 1563, 'deathsNumAffected': 6, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'T-ALL Post Induction Therapy', 'description': 'T-ALL patients who went off therapy at the end of induction, excluding patients who died at induction', 'otherNumAtRisk': 368, 'deathsNumAtRisk': 368, 'otherNumAffected': 0, 'seriousNumAtRisk': 368, 'deathsNumAffected': 39, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'T-ALL: Capizzi MTX Without Nelarabine', 'description': 'T-All patients who received Capizzi MTX without Nelarabine', 'otherNumAtRisk': 372, 'deathsNumAtRisk': 372, 'otherNumAffected': 357, 'seriousNumAtRisk': 372, 'deathsNumAffected': 26, 'seriousNumAffected': 18}, {'id': 'EG003', 'title': 'T-ALL: Capizzi MTX With Nelarabine', 'description': 'T-All patients who received Capizzi MTX with Nelarabine', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 134, 'seriousNumAtRisk': 147, 'deathsNumAffected': 10, 'seriousNumAffected': 44}, {'id': 'EG004', 'title': 'T-ALL: High Dose MTX Without Nelarabine', 'description': 'T-All patients who received High Dose MTX without Nelarabine', 'otherNumAtRisk': 451, 'deathsNumAtRisk': 451, 'otherNumAffected': 436, 'seriousNumAtRisk': 451, 'deathsNumAffected': 45, 'seriousNumAffected': 23}, {'id': 'EG005', 'title': 'T-ALL: High Dose MTX With Nelarabine', 'description': 'T-All patients who received High Dose MTX with Nelarabine', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 197, 'seriousNumAtRisk': 219, 'deathsNumAffected': 35, 'seriousNumAffected': 66}, {'id': 'EG006', 'title': 'T-LLy Induction Therapy', 'description': 'All patients diagnosed as T-LLy for induction', 'otherNumAtRisk': 285, 'deathsNumAtRisk': 285, 'otherNumAffected': 152, 'seriousNumAtRisk': 285, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'T-LLy Post Induction Therapy', 'description': 'T-LLy patients who went off therapy at the end of induction, excluding patients who died at induction', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 4, 'seriousNumAtRisk': 80, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'T-LLy: Capizzi MTX Without Nelarabine', 'description': 'T-LLy patients who received Capizzi MTX without Nelarabine', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 140, 'seriousNumAtRisk': 143, 'deathsNumAffected': 17, 'seriousNumAffected': 10}, {'id': 'EG009', 'title': 'T-LLy: Capizzi MTX With Nelarabine', 'description': 'T-LLy patients who received Capizzi MTX with Nelarabine', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 55, 'seriousNumAtRisk': 62, 'deathsNumAffected': 5, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 60, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 139, 'numAffected': 87}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 142, 'numAffected': 93}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bone marrow hypocellular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 101, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 504, 'numAffected': 233}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 153, 'numAffected': 87}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 614, 'numAffected': 283}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 168, 'numAffected': 102}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 160, 'numAffected': 91}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 52, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hemolytic uremic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pericardial tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (Combination Chemotherapy)', 'description': 'No Nelarabine, Capizzi Methotrexate'}, {'id': 'OG001', 'title': 'ARM II (Combination Chemotherapy)', 'description': 'Nelarabine, Capizzi Methotrexate'}, {'id': 'OG002', 'title': 'ARM III (Combination Chemotherapy)', 'description': 'No Nelarabine, High-Dose Methotrexate'}, {'id': 'OG003', 'title': 'ARM IV (Combination Chemotherapy)', 'description': 'Nelarabine, High-Dose Methotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '89.01', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '94.6'}, {'value': '90.53', 'groupId': 'OG001', 'lowerLimit': '85.0', 'upperLimit': '96.0'}, {'value': '78.07', 'groupId': 'OG002', 'lowerLimit': '71.2', 'upperLimit': '84.9'}, {'value': '86.46', 'groupId': 'OG003', 'lowerLimit': '80.6', 'upperLimit': '92.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Nelarabine versus No Nelarabine. T-LLY patients are excluded from this analysis. Induction failures non-randomly assigned to Arm IV were excluded from this analysis.'}, {'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I and ARM III (Combination Chemotherapy)', 'description': 'No Nelarabine (Combined)'}, {'id': 'OG001', 'title': 'ARM II and ARM IV (Combination Chemotherapy)', 'description': 'Nelarabine (Combined)'}], 'classes': [{'categories': [{'measurements': [{'value': '82.96', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '87.5'}, {'value': '88.30', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '92.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes subjects randomized to Nelarabine versus No Nelarabine'}, {'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (Combination Chemotherapy)', 'description': 'No Nelarabine, Capizzi Methotrexate'}, {'id': 'OG001', 'title': 'ARM II (Combination Chemotherapy)', 'description': 'Nelarabine, Capizzi Methotrexate'}, {'id': 'OG002', 'title': 'ARM III (Combination Chemotherapy)', 'description': 'No Nelarabine, High-Dose Methotrexate'}, {'id': 'OG003', 'title': 'ARM IV (Combination Chemotherapy)', 'description': 'Nelarabine, High-Dose Methotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '91.76', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '94.8'}, {'value': '90.53', 'groupId': 'OG001', 'lowerLimit': '85.0', 'upperLimit': '96.0'}, {'value': '86.06', 'groupId': 'OG002', 'lowerLimit': '82.2', 'upperLimit': '89.9'}, {'value': '84.89', 'groupId': 'OG003', 'lowerLimit': '78.0', 'upperLimit': '91.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Capizzi Methotrexate (CMTX) versus High-Dose Methotrexate (HDMTX). CNS3 patients non-randomly assigned to HDMTX (Arms III and IV) and Induction failures non-randomly assigned to Arm IV were excluded. T-LLY patients are excluded.'}, {'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I and ARM II (Combination Chemotherapy)', 'description': 'Capizzi Methotrexate (Combined)'}, {'id': 'OG001', 'title': 'ARM III and ARM IV (Combination Chemotherapy)', 'description': 'High-Dose Methotrexate (Combined)'}], 'classes': [{'categories': [{'measurements': [{'value': '91.45', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '94.1'}, {'value': '85.78', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '89.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes subjects randomized to Capizzi Methotrexate versus High-Dose Methotrexate'}, {'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (Combination Chemotherapy)', 'description': 'No Nelarabine, Capizzi Methotrexate'}, {'id': 'OG001', 'title': 'ARM II (Combination Chemotherapy)', 'description': 'Nelarabine, Capizzi Methotrexate'}], 'classes': [{'title': 'Standard Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '95.2'}]}]}, {'title': 'High Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '75.7', 'upperLimit': '94.5'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '95.0'}]}]}, {'title': 'Induction Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes T-cell lymphoblastic lymphoma (T-LLy) patients that are standard risk, high risk and induction failures. All Standard risk T-LLy patients only received Arm I. Induction failures were assigned to Arm II.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of CNS Relapse for T-ALL by Risk Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '451', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (Combination Chemotherapy)', 'description': 'No Nelarabine, Capizzi Methotrexate'}, {'id': 'OG001', 'title': 'ARM II (Combination Chemotherapy)', 'description': 'Nelarabine, Capizzi Methotrexate'}, {'id': 'OG002', 'title': 'ARM III (Combination Chemotherapy)', 'description': 'No Nelarabine, High-Dose Methotrexate'}, {'id': 'OG003', 'title': 'ARM IV (Combination Chemotherapy)', 'description': 'Nelarabine, High-Dose Methotrexate'}], 'classes': [{'title': 'Low Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '1.92', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5.7'}]}]}, {'title': 'Intermediate Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.5'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.2'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '12.2'}, {'value': '0.85', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2.5'}]}]}, {'title': 'High Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.52', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '12.8'}, {'value': '3.45', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only low risk, intermediate risk and high risk T-cell Acute Lymphoblastic Leukemia (T-ALL) subjects. There were no low risk participants on Arm II and Arm IV. Patients with CNS3, and Induction Failures are excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T-ALL Induction Therapy', 'description': 'All patients diagnosed as T-ALL for induction'}, {'id': 'FG001', 'title': 'T-LLy Induction Therapy', 'description': 'All patients diagnosed as T-LLy for induction'}, {'id': 'FG002', 'title': 'T-ALL: Capizzi MTX Without Nelarabine', 'description': 'T-All patients who received Capizzi MTX without Nelarabine'}, {'id': 'FG003', 'title': 'T-ALL: Capizzi MTX With Nelarabine', 'description': 'T-All patients who received Capizzi MTX with Nelarabine'}, {'id': 'FG004', 'title': 'T-ALL: High Dose MTX Without Nelarabine', 'description': 'T-All patients who received High Dose MTX without Nelarabine'}, {'id': 'FG005', 'title': 'T-ALL: High Dose MTX With Nelarabine', 'description': 'T-All patients who received High Dose MTX with Nelarabine'}, {'id': 'FG006', 'title': 'T-LLy: Capizzi MTX Without Nelarabine', 'description': 'T-LLy patients who received Capizzi MTX without Nelarabine'}, {'id': 'FG007', 'title': 'T-LLy: Capizzi MTX With Nelarabine', 'description': 'T-LLy patients who received Capizzi MTX with Nelarabine'}], 'periods': [{'title': 'Induction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1596'}, {'groupId': 'FG001', 'numSubjects': '299'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1189'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '407'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Refusal of Further Protocol Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Entered another COG therapeutic protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Patient transferred Tx to Non-COG Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Identified as Philadelphia Chr. Positive', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Inevaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Failed to Complete Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Hematopoietic Stem Cell Transplantation', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Recurrent leukemia', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Post Induction Therapy by Tx Assignment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '372'}, {'groupId': 'FG003', 'numSubjects': '147'}, {'groupId': 'FG004', 'numSubjects': '451'}, {'groupId': 'FG005', 'numSubjects': '219'}, {'groupId': 'FG006', 'numSubjects': '143'}, {'groupId': 'FG007', 'numSubjects': '62'}]}, {'type': 'Low Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '217'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Intermediate Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '95'}, {'groupId': 'FG004', 'numSubjects': '257'}, {'groupId': 'FG005', 'numSubjects': '93'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'High Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'CNS 3 and/or Testicular Disease', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '84'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'T-ALL M3 Marrow End of Induction', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '43'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'T-LLy Standard Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '82'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'T-LLy High Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '61'}, {'groupId': 'FG007', 'numSubjects': '60'}]}, {'type': 'T-LLy Induction Failure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '287'}, {'groupId': 'FG003', 'numSubjects': '103'}, {'groupId': 'FG004', 'numSubjects': '319'}, {'groupId': 'FG005', 'numSubjects': '118'}, {'groupId': 'FG006', 'numSubjects': '115'}, {'groupId': 'FG007', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '132'}, {'groupId': 'FG005', 'numSubjects': '101'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '45'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Refusal of Further Protocol Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Entered another COG therapeutic protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Patient transferred Tx to Non-COG Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '7'}]}, {'type': 'Inevaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Hematopoietic Stem Cell Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Recurrent Leukemia After Total Remission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Development of SMN', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Patients were stratified between the 2 disease groups (T-ALL and T-LLy) for Induction and then risk assigned treatment based upon the patient's response."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1596', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '1895', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T-ALL Induction Therapy', 'description': 'All patients diagnosed as T-ALL for induction'}, {'id': 'BG001', 'title': 'T-LLy Induction Therapy', 'description': 'All patients diagnosed as T-LLy for induction'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1493', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '1761', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.05', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '11.13', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '10.22', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '407', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1189', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '1398', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1307', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '1551', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1122', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '1330', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-24', 'size': 4417596, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-29T12:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1895}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2006-12-04', 'resultsFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2006-12-04', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-29', 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.'}, {'measure': 'Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event'}, {'measure': 'Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free.'}, {'measure': 'Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.'}, {'measure': 'Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort', 'timeFrame': '4 years from end of induction', 'description': 'Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Incidence of CNS Relapse for T-ALL by Risk Group', 'timeFrame': '4 years from randomization at the end of induction', 'description': 'Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.'}]}, 'conditionsModule': {'conditions': ['T Acute Lymphoblastic Leukemia', 'T Lymphoblastic Lymphoma']}, 'referencesModule': {'references': [{'pmid': '37556734', 'type': 'DERIVED', 'citation': "Wood BL, Devidas M, Summers RJ, Chen Z, Asselin B, Rabin KR, Zweidler-McKay PA, Winick NJ, Borowitz MJ, Carroll WL, Raetz EA, Loh ML, Hunger SP, Dunsmore KP, Teachey DT, Winter SS. Prognostic significance of ETP phenotype and minimal residual disease in T-ALL: a Children's Oncology Group study. Blood. 2023 Dec 14;142(24):2069-2078. doi: 10.1182/blood.2023020678."}, {'pmid': '36603187', 'type': 'DERIVED', 'citation': "Gossai NP, Devidas M, Chen Z, Wood BL, Zweidler-McKay PA, Rabin KR, Loh ML, Raetz EA, Winick NJ, Burke MJ, Carroll AJ, Esiashvili N, Heerema NA, Carroll WL, Hunger SP, Dunsmore KP, Winter SS, Teachey DT. Central nervous system status is prognostic in T-cell acute lymphoblastic leukemia: a Children's Oncology Group report. Blood. 2023 Apr 13;141(15):1802-1811. doi: 10.1182/blood.2022018653."}, {'pmid': '34302711', 'type': 'DERIVED', 'citation': 'Gaynon PS, Parekh C. A new standard of care for childhood T-cell acute lymphoblastic leukemia? Pediatr Blood Cancer. 2021 Oct;68(10):e29238. doi: 10.1002/pbc.29238. Epub 2021 Jul 24. No abstract available.'}, {'pmid': '32813610', 'type': 'DERIVED', 'citation': "Dunsmore KP, Winter SS, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Rabin KR, Zweidler-Mckay PA, Raetz EA, Loh ML, Schultz KR, Winick NJ, Carroll WL, Hunger SP. Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia. J Clin Oncol. 2020 Oct 1;38(28):3282-3293. doi: 10.1200/JCO.20.00256. Epub 2020 Aug 19."}, {'pmid': '32552472', 'type': 'DERIVED', 'citation': "Hayashi RJ, Winter SS, Dunsmore KP, Devidas M, Chen Z, Wood BL, Hermiston ML, Teachey DT, Perkins SL, Miles RR, Raetz EA, Loh ML, Winick NJ, Carroll WL, Hunger SP, Lim MS, Gross TG, Bollard CM. Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434. J Clin Oncol. 2020 Sep 10;38(26):3062-3070. doi: 10.1200/JCO.20.00531. Epub 2020 Jun 17."}, {'pmid': '30138085', 'type': 'DERIVED', 'citation': "Winter SS, Dunsmore KP, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Gaynon PS, Borowitz MJ, Loh ML, Rabin KR, Raetz EA, Zweidler-Mckay PA, Winick NJ, Carroll WL, Hunger SP. Improved Survival for Children and Young Adults With T-Lineage Acute Lymphoblastic Leukemia: Results From the Children's Oncology Group AALL0434 Methotrexate Randomization. J Clin Oncol. 2018 Oct 10;36(29):2926-2934. doi: 10.1200/JCO.2018.77.7250. Epub 2018 Aug 23."}], '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 randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To determine, through randomization, the relative safety and efficacy of the addition of nelarabine (Compound 506U78) to augmented Berlin-Frankfurt-Münster (BFM) therapy (Regimen C, Children's Cancer Group \\[CCG\\]-1961).\n\nII. To determine the relative safety and efficacy of high dose methotrexate (5 g/m\\^2) with leucovorin (leucovorin calcium) rescue compared to escalating methotrexate without leucovorin rescue plus pegaspargase (Capizzi I) delivered during interim maintenance.\n\nIII. To gain preliminary data on the use of nelarabine in patients with high risk T-cell lymphoblastic lymphoma and its effect on long-term survival.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the relative safety and efficacy of withholding radiation in patients with low risk T-cell acute lymphoblastic leukemia (T-ALL), while treating Intermediate and high risk patients with 1200 cGy of prophylactic cranial radiation.\n\nOUTLINE: This is a randomized, controlled, factorial-group, multicenter study.\n\nGROUP 0 (INDUCTION THERAPY): All patients (T-ALL and T-LLy) receive cytarabine intrathecally (IT) on day 1; vincristine sulfate intravenously (IV) on days 1, 8, 15, and 22; prednisone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; duanorubicin IV on days 1, 8, 15 and 22; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease).\n\nGROUP I ARM I COMBINATION CHEMOTHERAPY (CONSOLIDATION CHEMOTHERAPY): Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo conformal radiation therapy (CRT). Patients with standard risk T-LLy received Arm I, and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy.\n\nGROUP I ARM I COMBINATION CHEMOTHERAPY (DELAYED INTENSIFICATION CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10). Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II.\n\nGROUP I ARM I COMBINATION CHEMOTHERAPY (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase\\* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose (DS patients excluded as of 09/29/10).\n\nNote: \\*Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2, 4, 6, 8, 10, 12, 22, 24, 26, 28, 30, and 32.\n\nGROUP I ARM I COMBINATION CHEMOTHERAPY (MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL), all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).\n\nGROUP I ARM II COMBINATION CHEMOTHERAPY (CONSOLIDATION CHEMOTHERAPY): Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35. Patients with high risk T-LLy were either randomized to Arm I or Arm II. Patients with T-LLy who failed induction therapy were assigned to Arm II.\n\nGROUP I ARM II COMBINATION CHEMOTHERAPY (DELAYED INTENSIFICATION CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.\n\nGROUP I ARM II COMBINATION CHEMOTHERAPY (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase\\* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31.\n\nNote: \\*Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday, Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution.\n\nGROUP I ARM II COMBINATION CHEMOTHERAPY (MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).\n\nGROUP I ARM III COMBINATION CHEMOTHERAPY (CONSOLIDATION CHEMOTHERAPY): Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.\n\nGROUP I ARM III COMBINATION CHEMOTHERAPY (DELAYED INTENSIFICATION CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10).\n\nGROUP I ARM III COMBINATION CHEMOTHERAPY (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive high dose methotrexate (HDMTX) IV over 24 hours and vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.\n\nGROUP I ARM III COMBINATION CHEMOTHERAPY (MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).\n\nGROUP I ARM IV COMBINATION CHEMOTHERAPY (CONSOLIDATION CHEMOTHERAPY): Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35.\n\nGROUP I ARM IV COMBINATION CHEMOTHERAPY (DELAYED INTENSIFICATION CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.\n\nGROUP I ARM IV COMBINATION CHEMOTHERAPY (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.\n\nGROUP I ARM IV COMBINATION CHEMOTHERAPY (MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).\n\nAfter completion of study therapy, patients are followed periodically for at least 10 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434\n* Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation \\[CD\\]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory\n* T-NHL PATIENTS:\n\n * For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted\n* Prior therapy restrictions\n\n * Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine\n * IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the 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 * Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients CANNOT be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented\n * For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study\n* Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in eligibility are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years\n\nExclusion Criteria:\n\n* Pregnant or lactating females are ineligible\n* Patients with Down syndrome are ineligible to enroll onto this study\n* For T-NHL patients the following additional exclusion criteria apply:\n\n * B-precursor lymphoblastic lymphoma\n * Morphologically unclassifiable lymphoma\n * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma\n * CNS3-positive or testicular involvement"}, 'identificationModule': {'nctId': 'NCT00408005', 'briefTitle': 'Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma', 'orgStudyIdInfo': {'id': 'NCI-2009-00307'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00307', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-AALL0434'}, {'id': '07-169'}, {'id': 'CDR0000514500'}, {'id': 'AALL0434', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AALL0434', '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': 'Group 0 Induction Therapy', 'description': 'All patients (T-ALL and T-LLy) receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; prednisone IV or PO twice daily BID on days 1-28; pegaspargase IM (may give IV over 1 to 2 hours) on day 4, 5, or 6; daunorubicin hydrochloride IV on days 1, 8, 15 and 22; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease).', 'interventionNames': ['Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Drug: Prednisone', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 Arm IV (Consolidation chemotherapy)', 'description': 'Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Nelarabine', 'Drug: Pegaspargase', 'Radiation: Radiation Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm I (Consolidation chemotherapy)', 'description': 'Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT. Patients with standard risk T-LLy received Arm I, and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm I (Delayed intensification chemotherapy', 'description': 'Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10). Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Drug: Leucovorin Calcium', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm I (Maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL), all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Prednisone', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm I (Interim maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase\\* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose (DS patients excluded as of 09/29/10).\n\nNote: \\*Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2, 4, 6, 8, 10, 12, 22, 24, 26, 28, 30, and 32.', 'interventionNames': ['Drug: Leucovorin Calcium', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm II (Consolidation chemotherapy)', 'description': 'Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35. Patients with high risk T-LLy were either randomized to Arm I or Arm II. Patients with T-LLy who failed induction therapy were assigned to Arm II.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Nelarabine', 'Drug: Pegaspargase', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm II (Delayed intensification chemotherapy)', 'description': 'Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Drug: Nelarabine', 'Drug: Pegaspargase', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm II (Interim maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase\\* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31.\n\nNote: \\*Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday, Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution.', 'interventionNames': ['Drug: Asparaginase', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm II (Maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).', 'interventionNames': ['Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Nelarabine', 'Drug: Prednisone', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm III (Consolidation chemotherapy)', 'description': 'Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm III (Delayed intensification chemotherapy)', 'description': 'Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10).', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Drug: Leucovorin Calcium', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm III (Interim maintenance chemotherapy)', 'description': 'Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm III (Maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).', 'interventionNames': ['Drug: Methotrexate', 'Drug: Prednisone', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm IV (Delayed intensification chemotherapy)', 'description': 'Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients \\< 10 years of age) OR on days 1-7 and 15-21 (for patients \\>= 10 years of age); doxorubicin IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Drug: Methotrexate', 'Drug: Nelarabine', 'Drug: Pegaspargase', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm IV (Interim maintenance chemotherapy)', 'description': 'Patients receive HDMTX IV over 24 hours and vincristine IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I Arm IV (Maintenance chemotherapy)', 'description': 'Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).', 'interventionNames': ['Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Nelarabine', 'Drug: Prednisone', '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 IM or IV', 'armGroupLabels': ['Group I Arm II (Interim maintenance chemotherapy)']}, {'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': ['Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'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 IT, IV, or SC', 'armGroupLabels': ['Group 0 Induction Therapy', 'Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'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': ['Group 0 Induction Therapy']}, {'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': ['Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'FI106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group I Arm I (Maintenance chemotherapy)', 'Group I Arm III (Interim maintenance chemotherapy)', 'Group I Arm IV (Interim maintenance chemotherapy)']}, {'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 PO', 'armGroupLabels': ['Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm I (Interim maintenance chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm III (Interim maintenance chemotherapy)', 'Group I Arm IV (Interim maintenance chemotherapy)']}, {'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': ['Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Maintenance chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Maintenance chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Interim maintenance chemotherapy)', 'Group I Arm IV (Interim maintenance chemotherapy)', 'Group I Arm IV (Maintenance chemotherapy)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abitrexate', 'Alpha-Methopterin', 'Amethopterin', 'Brimexate', 'CL 14377', 'CL-14377', 'Emtexate', 'Emthexat', 'Emthexate', 'Farmitrexat', 'Fauldexato', 'Folex', 'Folex PFS', 'Jylamvo', 'Lantarel', 'Ledertrexate', 'Lumexon', 'Maxtrex', 'Medsatrexate', 'Metex', 'Methoblastin', 'Methotrexate LPF', 'Methotrexate Methylaminopterin', 'Methotrexatum', 'Metotrexato', 'Metrotex', 'Mexate', 'Mexate-AQ', 'MTX', 'Novatrex', 'Rheumatrex', 'Texate', 'Tremetex', 'Trexeron', 'Trixilem', 'WR-19039'], 'description': 'Given IT or PO', 'armGroupLabels': ['Group 0 Induction Therapy', 'Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm I (Interim maintenance chemotherapy)', 'Group I Arm I (Maintenance chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Interim maintenance chemotherapy)', 'Group I Arm II (Maintenance chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm III (Interim maintenance chemotherapy)', 'Group I Arm III (Maintenance chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)', 'Group I Arm IV (Interim maintenance chemotherapy)', 'Group I Arm IV (Maintenance chemotherapy)']}, {'name': 'Nelarabine', 'type': 'DRUG', 'otherNames': ['2-Amino-6-methoxypurine arabinoside', '506U78', 'Arranon', 'Compound 506U78', 'GW506U78'], 'description': 'Given IV', 'armGroupLabels': ['Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm II (Maintenance chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)', 'Group I Arm IV (Maintenance chemotherapy)']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'otherNames': ['L-Asparaginase with Polyethylene Glycol', 'Oncaspar', 'Oncaspar-IV', 'PEG-Asparaginase', 'PEG-L-Asparaginase', 'PEG-L-Asparaginase (Enzon - Kyowa Hakko)', 'PEGLA', 'Polyethylene Glycol L-Asparaginase', 'Polyethylene Glycol-L-Asparaginase'], 'description': 'Given IM or IV', 'armGroupLabels': ['Group 0 Induction Therapy', 'Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm I (Interim maintenance chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm II (Interim maintenance chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['.delta.1-Cortisone', '1, 2-Dehydrocortisone', 'Adasone', 'Cortancyl', 'Dacortin', 'DeCortin', 'Decortisyl', 'Decorton', 'Delta 1-Cortisone', 'Delta-Dome', 'Deltacortene', 'Deltacortisone', 'Deltadehydrocortisone', 'Deltasone', 'Deltison', 'Deltra', 'Econosone', 'Lisacort', 'Meprosona-F', 'Metacortandracin', 'Meticorten', 'Ofisolona', 'Orasone', 'Panafcort', 'Panasol-S', 'Paracort', 'Perrigo Prednisone', 'PRED', 'Predicor', 'Predicorten', 'Prednicen-M', 'Prednicort', 'Prednidib', 'Prednilonga', 'Predniment', 'Prednisone Intensol', 'Prednisonum', 'Prednitone', 'Promifen', 'Rayos', 'Servisone', 'SK-Prednisone'], 'description': 'Given IV or PO', 'armGroupLabels': ['Group 0 Induction Therapy', 'Group I Arm I (Maintenance chemotherapy)', 'Group I Arm II (Maintenance chemotherapy)', 'Group I Arm III (Maintenance chemotherapy)', 'Group I Arm IV (Maintenance chemotherapy)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Energy Type', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Some patients undergo testicular and/or prophylactic cranial RT', 'armGroupLabels': ['Group 1 Arm IV (Consolidation chemotherapy)', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)']}, {'name': 'Thioguanine', 'type': 'DRUG', 'otherNames': ['2-Amino 6MP', '2-Amino-1,7-dihydro-6H-purine-6-thione', '2-Amino-6-mercaptopurine', '2-Amino-6-purinethiol', '2-Aminopurin-6-thiol', '2-Aminopurine-6(1H)-thione', '2-Aminopurine-6-thiol', '2-Aminopurine-6-thiol Hemihydrate', '2-Mercapto-6-aminopurine', '6-Amino-2-mercaptopurine', '6-Mercapto-2-aminopurine', '6-Mercaptoguanine', '6-TG', '6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)', 'BW 5071', 'Lanvis', 'Tabloid', 'Thioguanine Hemihydrate', 'Thioguanine Hydrate', 'Tioguanin', 'Tioguanine', 'Wellcome U3B', 'WR-1141', 'X 27'], 'description': 'Given PO', 'armGroupLabels': ['Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Group 0 Induction Therapy', 'Group I Arm I (Consolidation chemotherapy)', 'Group I Arm I (Delayed intensification chemotherapy', 'Group I Arm I (Interim maintenance chemotherapy)', 'Group I Arm I (Maintenance chemotherapy)', 'Group I Arm II (Consolidation chemotherapy)', 'Group I Arm II (Delayed intensification chemotherapy)', 'Group I Arm II (Interim maintenance chemotherapy)', 'Group I Arm II (Maintenance chemotherapy)', 'Group I Arm III (Consolidation chemotherapy)', 'Group I Arm III (Delayed intensification chemotherapy)', 'Group I Arm III (Interim maintenance chemotherapy)', 'Group I Arm III (Maintenance chemotherapy)', 'Group I Arm IV (Delayed intensification chemotherapy)', 'Group I Arm IV (Interim maintenance chemotherapy)', 'Group I Arm IV (Maintenance chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Health Strada Patient Care Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Downey Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 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