23
Participants
Start Date
June 30, 2010
Primary Completion Date
November 30, 2015
Study Completion Date
July 18, 2016
Nelarabine
Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
Etoposide
100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
Cyclophosphamide
Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
Methotrexate
"Give between day 29 and 36 or when ANC\>750 and PLTS\>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.~Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but \<2 years of age 10 mg for patients age greater than or equal to 2, but \<3 years of age 12 mg for patients greater than or equal to 3, but \< 9 years of age 15 mg for patients greater than or equal to \>9 years of age"
Filgrastim
5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000/mm3 for two consecutive days.
New York University Medical Center, New York
Children's Hospital New York-Presbyterian, New York
Levine Children's Hospital at Carolinas Medical Center, Charlotte
University of Miami Cancer Center, Miami
Children's Mercy Hospitals and Clinics, Kansas City
The Children's Hospital, University of Colorado, Aurora
Childrens Hospital Los Angeles, Los Angeles
Seattle Children's Hospital, Seattle
Children's Hospital Orange County, Orange
Children's National Medical Center, Washington D.C.
Children's Healthcare of Atlanta, Emory University, Atlanta
Lurie Children's Hospital, Chicago
Johns Hopkins University, Baltimore
Dana Farber, Boston
Rainbow Babies, Cleveland
Nationwide Childrens Hospital, Columbus
Oregon Health and Science University, Portland
Vanderbilt Children's Hospital, Nashville
University of Texas at Southwestern, Dallas
Cook Children's Hospital, Fort Worth
Primary Children's, Salt Lake City
Medical College of Wisconsin, Milwaukee
Children's Hospital at Westmead, Westmead
Royal Children's Hospital, Brisbane
Royal Children's Hospital, Melbourne, Melbourne
Sydney Children's Hospital, Sydney
St. Anna Children's Hospital, Vienna
Hospital for Sick Kids, Toronto
Sainte Justine University Hospital, Montreal
British Columbia Children's Hospital, Vancouver
CHU Lille, Lille
Bambino Gesù Hospital, Rome
Erasmus MC - Sophia, Rotterdam
UCSF School of Medicine, San Francisco
C.S. Mott Children's Hospital, Ann Arbor
Childrens Hospital & Clinics of Minnesota, Minneapolis
St. Jude, Memphis
Collaborators (2)
GlaxoSmithKline
INDUSTRY
Novartis
INDUSTRY
Therapeutic Advances in Childhood Leukemia Consortium
OTHER