Study: NCT02419469

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Participants initially receive intrathecal treatment using Cytarabine 100 mg on Day 1. Induction chemotherapy must begin within 3 days of the intrathecal Cytarabine dose.~Consolidation Therapy 1: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and 8 - 11.~Consolidation Therapy 3B: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and Days 8 - 11.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Induction Therapy: Vincristine 1.5 mg/m2 by vein weekly for 4 doses.~Consolidation Therapy 1: Vincristine 1.5 mg/m2 by vein Week 3 and Week 4.~Consolidation Therapy 2: Vincristine 1.5 mg/m2 by vein every 10 days for 5 doses.~Consolidation Therapy 3A: Vincristine 1.5 mg/m2 by vein weekly for 3 doses.~Consolidation Therapy 3B: Vincristine 1.5 mg/m2 by vein Weeks 3 and 4.~Maintenance Therapy (24 months): Vincristine 1.5 mg/m2 by vein every 28 days.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG asparaginase
Description: Induction Therapy: PEG asparaginase 2000 IU/m2 by vein on Day 4 of induction.~Consolidation Therapy 1: PEG-asparaginase 2000 IU/m2 by vein Week 3 and Week 7.~Consolidation Therapy 2: PEG-asparaginase 2000 IU/m2 by vein Weeks 1 and 4.~Consolidation Therapy 3A: PEG-asparaginase 2000 IU/m2 by vein in Week 1.~Consolidation Therapy 3B: PEG-asparaginase 2000 IU/m2 by vein Week 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ofatumumab
Description: Induction Therapy: Ofatumumab 300 mg by injection or vein on Day 2 and Ofatumumab 2000 mg by injection or vein on Day 15.~Consolidation Therapy 1: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.~Consolidation Therapy 2: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.~Consolidation Therapy 3A: Ofatumumab 2000 mg by injection or vein Week 1 and Week 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Induction Therapy: If Ofatumumab not available, Rituximab 375 mg/m2 by vein on Day 1 and on Day 15.~Consolidation Therapy 1: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.~Consolidation Therapy 2: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.~Consolidation Therapy 3A: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Induction Therapy: Intrathecal methotrexate 12 mg on Day 8 and Day 29.~Consolidation Therapy 1: Intrathecal methotrexate 12 mg Weekly, Weeks 1 - 4.~Consolidation Therapy 2: Methotrexate by vein every 10 days starting at 100 mg/m2 and increasing by 50 mg/m2 as tolerated. and Intrathecal methotrexate 12 mg Week 1.~Consolidation Therapy 3A: Intrathecal methotrexate 12 mg in Week 1.~Consolidation Therapy 3B: Intrathecal methotrexate 12 mg Week 1 and 2.~Maintenance Therapy (24 months): Methotrexate 20 mg/m2 by mouth weekly, hold on days of intrathecal methotrexate.~Maintenance Therapy (24 months): Intrathecal methotrexate 12 mg every 3 months for 4 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Consolidation Therapy 1: Cyclophosphamide 1 gram/m2 by vein Week 1 and Week 5.~Consolidation Therapy 3B: Cyclophosphamide 1 gram/m2 by vein Week 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14.~Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone acetate
Description: Consolidation Therapy 3A: Dexamethasone 10 mg/m2 by mouth on Days 1 - 7 and Days 15 - 21.~Maintenance Therapy (24 months): Dexamethasone 6 mg/m2/day by mouth Days 1 - 5 every 28 days.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thioguanine
Description: Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.