Study: NCT03817320

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib
Description: Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses~Dose Phase 1 - Assigned upon study entry.~Phase 2 - PO formulation at RP2D

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib
Description: Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses~Dose Phase 1 - Assigned upon study entry.~Phase 2 - PO formulation at RP2D

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib
Description: Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses~Dose Phase 1 - Assigned upon study entry.~Phase 2 - PO formulation at RP2D

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib
Description: Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses~Dose Phase 1 - Assigned upon study entry.~Phase 2 - PO formulation at RP2D

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV push over 1 minute or infusion via minibag as per institutional policy~Days 1, 8, 15 and 22~Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)~≥ 6 months and \< 1 year: 1.2mg/m2/dose~\< 6 months: 1mg/m2/dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV push over 1 minute or infusion via minibag as per institutional policy~Days 1, 8, 15 and 22~Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)~≥ 6 months and \< 1 year: 1.2mg/m2/dose~\< 6 months: 1mg/m2/dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV push over 1 minute or infusion via minibag as per institutional policy~Days 1, 8, 15 and 22~Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)~≥ 6 months and \< 1 year: 1.2mg/m2/dose~\< 6 months: 1mg/m2/dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV push over 1 minute or infusion via minibag as per institutional policy~Days 1, 8, 15 and 22~Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)~≥ 6 months and \< 1 year: 1.2mg/m2/dose~\< 6 months: 1mg/m2/dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Days 1-14~Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)~≥ 6 months and \< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)~\< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Days 1-14~Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)~≥ 6 months and \< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)~\< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Days 1-14~Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)~≥ 6 months and \< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)~\< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Days 1-14~Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)~≥ 6 months and \< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)~\< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Asparaginase
Description: Days 2, 15~Dose ≥ 1 year: 2,500 International units (IU)/m2/dose~≥ 6 months and \< 1 year: 2,000 IU/m2/dose~\< 6 months: 1,750 IU/m2/dose~Patient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase.~Dosing guideline for Erwinase:~* 1 year: 25,000 IU/m2/dose~* 6 months and \< 1 year: 20,000 IU/m2/dose~\< 6 months: 17,500 IU/m2/dose