112
Participants
Start Date
April 30, 2007
Primary Completion Date
September 30, 2013
Study Completion Date
March 31, 2020
Doxorubicin
Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.
Cytarabine
Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks
Methotrexate
"Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).~Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks."
Vincristine
Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.
Cyclophosphamide
Consolidation IB: Intravenously on day 1
Methylprednisone
Prophase: Intravenously on days 1-3
Hydrocortisone Sodium Succinate
Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.
Dexamethasone
Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.
6-MP
Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.
PEG-Asparaginase
"Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.~Consolidation II: Intravenously every 3 weeks."
Imatinib
Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.
Etoposide
Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.
Radiation Therapy
Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF
E. coli Asparaginase
Intramuscularly Day 7 of Induction.
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York
Ohio State University Medical Center, Columbus
LDS Hospital, Salt Lake City
Massachusetts General Hospital, Boston
Children's Hospital of Boston, Boston
Beth Isreal Deaconess Medical Center, Boston
Dana-Farber Cancer Institute, Boston
Vancouver Cancer Center, Vancouver
Cancer Care Manitoba, Winnipeg
The Moncton Hospital, Moncton
Hopital Notre-Dame, Montreal
McGill University Department of Oncology, Montreal
QEII, Health Sciences Centre, Halifax
Hopital Charles LeMoyne, Greenfield Park
Hopital Maisonneuve Rosemont, Montreal
Collaborators (1)
Massachusetts General Hospital
OTHER
Boston Children's Hospital
OTHER
NCIC Clinical Trials Group
NETWORK
Dana-Farber Cancer Institute
OTHER