{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.5","upperLimit":"98.8","value":"79.2"},{"groupId":"OG001","lowerLimit":"32.4","upperLimit":"100","value":"69.9"},{"groupId":"OG002","lowerLimit":"50.2","upperLimit":"81.0","value":"65.6"},{"groupId":"OG003","lowerLimit":"49.9","upperLimit":"100","value":"86.2"},{"groupId":"OG004","lowerLimit":"70.8","upperLimit":"100","value":"93.8"},{"groupId":"OG005","lowerLimit":"49.4","upperLimit":"76.8","value":"63.1"},{"groupId":"OG006","lowerLimit":"66.53","upperLimit":"100","value":"84.2"},{"groupId":"OG007","lowerLimit":"59.8","upperLimit":"87.4","value":"73.6"},{"groupId":"OG008","lowerLimit":"60.9","upperLimit":"88.3","value":"74.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"17"},{"groupId":"OG005","value":"116"},{"groupId":"OG006","value":"20"},{"groupId":"OG007","value":"112"},{"groupId":"OG008","value":"44"}],"units":"Participants"}],"description":"Bone marrow MRD status is defined as positive with \\>= 0.1 detectable leukemia cells, and negative with \\< 0.1 detectable leukemia cells.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"OG000","title":"Dexamethasone and Capizzi Methotrexate Patients < 10 Years"},{"description":"Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"OG001","title":"Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)"},{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"OG002","title":"Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"OG003","title":"Dexamethasone, High Dose Methotrexate (IM) < 10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"OG004","title":"Prednisone, Capizzi Methotrexate <10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"OG005","title":"Prednisone, Capizzi Methotrexate >= 10 Years"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"OG006","title":"Predisone and High Dose Methotrexate < 10 Yrs Old"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"OG007","title":"Prednisone and High Dose Methotrexate >=10 Years"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"OG008","title":"Dexamethasone, High Dose Methotrexate (IM) >= 10 Years"}],"paramType":"NUMBER","populationDescription":"Groups \"Prednisone Capizzi MTX (Down's Syndrome)\", \"Dexamethasone, Capizzi MTX (non-random)\" \\& \"Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.","reportingStatus":"POSTED","timeFrame":"5 Years","title":"Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}