{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"description":"Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).","groups":[{"description":"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo","id":"OG000","title":"Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs"},{"description":"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo","id":"OG001","title":"Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs"},{"description":"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo","id":"OG002","title":"Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs"},{"description":"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nmethotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo","id":"OG003","title":"T-cell ALL (Chemotherapy)"},{"description":"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo","id":"OG004","title":"T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)"}],"populationDescription":"These were for correlative biology studies and the data were not collected in COG database.","reportingStatus":"POSTED","timeFrame":"Up to day 8 of block 2","title":"Plasma Concentration-time Profiles","type":"OTHER_PRE_SPECIFIED"}