50
Participants
Start Date
January 29, 2016
Primary Completion Date
May 10, 2022
Study Completion Date
October 31, 2031
ITMHA
Given intrathecally (IT).
Dexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
Mitoxantrone
Given IV.
Pegaspargase
Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.
Asparaginase Erwinia Chrysanthemi
Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).
Bortezomib
Given IV.
Vorinostat
Taken PO or NG.
Cyclophosphamide
Given IV.
Mercaptopurine
Given PO or NG.
Methotrexate
Given IV, IM or PO.
Leucovorin Calcium
Leucovorin rescue PO or IV.
Cytarabine
Given IV.
Etoposide
Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.
Vincristine
Given IV.
Children's Hospital of the King's Daughters (CHKD), Norfolk
St. Jude Affiliate-Charlotte, Charlotte
St. Jude Children's Research Hospital, Memphis
Cincinnati Children's Hospital, Cincinnati
Children's Hospital and Clinics of Minnesota, Minneapolis
Children's Hospital Los Angeles, Los Angeles
Rady Children's Hospital and Health Center, San Diego
Children's Hospital of Orange County, Orange
Lucile Packard Children's Hospital Stanford University, Palo Alto
Oregon Health and Science University, Portland
Alberta Children's Hospital, Calgary
Stollery Children's Hospital, Edmonton
Children's & Women's Health Centre of British Columbia, Vancouver
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton
Centre Hospitalier Universitaire Sainte-Justine, Montreal
The Montreal Children's Hospital (MUHC-McGill), Montreal
Centre Hospitalier Universitaire de Quebec, Québec
Gateway for Cancer Research
OTHER
Baylor College of Medicine
OTHER
St. Jude Children's Research Hospital
OTHER