206
Participants
Start Date
June 15, 2017
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2027
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
St. Jude Children's Research Hospital, Memphis
Children's Hospital of Michigan, Detroit
Sanford Children's Specialty Clinic, Sioux Falls
University of Chicago Children's Hospital (Comer), Chicago
Cook Children's Medical Center, Fort Worth
Rady Children's Hospital and Health Center, San Diego
Children's Hospital of Orange County, Orange
Children's Hospital of Central California, Madera
Lucile Packard Children's Hospital Stanford University, Palo Alto
Dana-Farber Cancer Institute, Boston
St. Jude Children's Research Hospital
OTHER