{"groups":[{"description":"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone 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; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \\< 0.1% OR MRD \\>= 0.1% and \\< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \\>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nvincristine sulfate: Given IV","id":"FG000","title":"Group 0 Induction Therapy"},{"description":"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG001","title":"Group 1-SR-low ALL, Arm I-combination Chemotherapy"},{"description":"Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG002","title":"Group 1-SR-low ALL, Arm II-combination Chemotherapy"},{"description":"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG003","title":"Group 2-SR-avg ALL, Arm I-combination Chemotherapy"},{"description":"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG004","title":"Group 2-SR-avg ALL, Arm II-combination Chemotherapy"},{"description":"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG005","title":"Group 2-SR-avg ALL, Arm III-combination Chemotherapy"},{"description":"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"FG006","title":"Group 2-SR-avg ALL, Arm IV-combination Chemotherapy"},{"description":"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine \\& vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\n3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine","id":"FG007","title":"Group 3-SR-high ALL, Combination Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"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":"Adverse 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Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"13"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"35"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"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 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