24
Participants
Start Date
February 12, 2019
Primary Completion Date
December 3, 2023
Study Completion Date
June 30, 2025
Ixazomib
"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"
Vincristine
"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"
Dexamethasone
"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)"
Asparaginase
"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"
Doxorubicin
"Day 1~Dose ≥ 1 year: 60mg/m2/dose~≥ 6 months and \< 1 year: 48 mg/m2/dose~\< 6 months: 42mg/m2/dose"
Methotrexate (IT)
For patients with CNS 1 or CNS 2, on Days 1, 15, and 29
Triple IT (Methotrexate, Hydrocortisone, Cytarabine)
For patients with CNS 3, on Days 1, 8, 15, 22, and 29
Leucovorin
For patients with Down syndrome only, on Days 2, 9, 16, 23, and 30 (based on dates when IT Methotrexate or Triple IT is given)
The Children's Hospital at Westmead, Westmead
Columbia University Medical Center, New York
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
Levine Cancer Institute, Charlotte
Children's Healthcare of Atlanta, Atlanta
University of Miami, Miami
St. Jude Children's Research Hospital, Memphis
Nationwide Children's Hospital, Columbus
University Hospitals Seidman Cancer Center, Cleveland
C.S. Mott Children's Hospital, Ann Arbor
Children's Hospital and Clinics of Minnesota, Minneapolis
University of Texas, Southwestern, Dallas
Cook Children's Medical Center, Fort Worth
Texas Children's Hospital/Baylor University, Houston
Children's Hospital Los Angeles, Los Angeles
Children's Hospital Orange County, Orange
Doernbecher Children's Hospital, Portland
Collaborators (1)
Takeda
INDUSTRY
Children's Hospital Los Angeles
OTHER
Therapeutic Advances in Childhood Leukemia Consortium
OTHER