37
Participants
Start Date
July 11, 2017
Primary Completion Date
July 9, 2020
Study Completion Date
February 10, 2022
Decitabine
Dose Level #0: 5 mg/m2 Dose Level #1: 7.5 mg/m2 Dose Level #2: 10 mg/m2 Dose Level #3: 15 mg/m2 Dose Level #4: 20 mg/m2 given IV over \_\_ hour on days 1 through 5
Vorinostat
Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF)
Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine
30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine
2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
Sydney Children's Hospital, Randwick
New York University Medical Center, New York
Children's Hospital New York-Presbyterian, New York
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
National Cancer Institute, Pediatric Oncology Branch, Bethesda
Johns Hopkins University, Baltimore
Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore
Levine Children's Hospital, Charlotte
Children's Healthcare of Atlanta, Emory University, Atlanta
University of Miami, Miami
All Children's Hospital, St. Petersburg
Nationwide Children's Hospital, Columbus
Cincinnati Children's Hospital, Cincinnati
CS Mott Children's Hospital, Ann Arbor, Ann Arbor
Medical College of Wisconsin, Milwaukee
Children's Hospitals and Clinics of Minnesota, Minneapolis
Lurie Children's Hospital of Chicago, Chicago
Cook Children's Medical Center, Fort Worth
Texas Children's Cancer Center, Baylor, Houston
The Children's Hospital, University of Colorado, Aurora
Primary Children's Hospital, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
Children's Hospital Orange County, Orange
UCSF School of Medicine, San Francisco
Oregon Health and Science University, Portland
Seattle Children's Hospital, Seattle
Dana-Farber Cancer Institute, Boston
C.S. Mott Children's Hospital, Ann Arbor
Children's Hospital at Westmead, Westmead
Sainte Justine University Hospital, Montreal
British Columbia Children's Hospital, Vancouver
Hospital for Sick Children, Toronto
Therapeutic Advances in Childhood Leukemia Consortium
OTHER