560
Participants
Start Date
March 3, 2017
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2034
Pegaspargase
Arm A: Standard/Fixed Dose Pegaspargase (2500 IU/m2 every 2 weeks) Arm B: Reduced Dose (PK-adjusted) Pegaspargase (Starting Dose: 2000 IU/m2) Arm X: Directly Assigned Standard Dose (2500 IU/m2): For all VHR and patients who decline randomization
Erwinia asparaginase
Only for patients with Pegaspargase allergy or silent inactivation.
Cyclophosphamide
Standard of Care
CYTARABINE
Standard of Care
DASATINIB
Standard of Care
DEXAMETHASONE
Standard of Care
Dexrazoxane
Standard of Care
Doxorubicin
Standard of Care
ETOPOSIDE
Standard of Care
HYDROCORTISONE
Standard of Care
LEUCOVORIN CALCIUM
Standard of Care
MERCAPTOPURINE
Standard of Care
METHOTREXATE
Standard of Care
NELARABINE
Standard of Care
Vincristine
Standard of Care
Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian, New York
Montefiore Medical Center, The Bronx
Roswell Park Cancer Institute, Buffalo
Boston Children's Hospital, Boston
Dana-Farber Cancer Institute, Boston
Rutgers Cancer Institute of New Jersey, New Brunswick
Hasbro Children's Hospital / Rhode Island Hospital, Providence
Hospital Sainte Justine, University of Montreal, Montreal
Centre Hospitalier U. de Quebec, Québec
Servier
INDUSTRY
Dana-Farber Cancer Institute
OTHER