31
Participants
Start Date
January 31, 2014
Primary Completion Date
April 14, 2022
Study Completion Date
April 14, 2022
DNR
Daunorubicin 60 mg/m2 IV (in the vein) daily 1,2,3 Courses 1A, 2A
VCR
1.4 mg/m2 IV, days 1, 8, 15, 22 (cap at 2mg for ages \>50) during Courses 1A, 2A; Maintenance: Day 1 during months 2-12
PEG-asp
2,000 IU/m2 IV for ages \</= 50, age \> 50, 1000 IU/m2 IV Day 16, Courses 1A \& 2A; Day 18, Course 1B; Day 17, Course 2B; Day 16, Maintenance, Month 1
CTX
750 mg/m2 IV, days 1 \&15 for subjects \<40 year of age, substitute cyclophosphamide 500 mg/m2 IV over 60 minutes every 12 hours for 4 doses on days 15 \& 16 for subjects \< 40 years of age if day 14 bone marrow M2 or M3; Courses 1A \& 2A
Prednisone
60 mg/m2 orally once daily on days 1-28 during Courses 1A \& 2A; Maintenance: Monthly, days 1-5
Liposomal AraC
25 mg intrathecal (IT), on days 1 \& 15 during Courses 1A \& 2A; 50 mg intrathecal on day 1 during Maintenance Months 1 through 4
MTX
220 mg/m2 IV bolus over 15 minutes then 60 mg/m2/hour for 36 hours once on days 2-3 and 16-17 during Courses 1B \& 2B; 20 mg/m2 orally one day per week every 7 days during Maintenance Months
LCV
50 mg/m2 IV over 15-30 minutes every 6 hours for 3 doses to begin immediately after completion of methotrexate infusion, then 10 mg/m2 orally or IV over 15-30 minutes every 6 hours until methotrexate level less than 0.1 micromolar during Courses 1B \& 2B
AraC
2,000 mg/m2 IV, days 1-4 during Courses 1C \& 2C
Etoposide
500 mg/m2 IV over 3 hours once daily on days 1-4 during Courses 1C \& 2C
Dasatinib
140 mg orally daily if BCR/ABL positive and/or Ph+
Rituximab
375 mg/m2 IV once daily on days 1 \& 15 (precursor B-cell ALL only, administer per institutional protocol) during Courses 1A, 1B, 1C \& 2A
Hydrocortisone
Randomize patients proceeding to Course 1B to hydrocortisone versus placebo prior to PEG-asparaginase treatments in Courses 1B, 2B, 3B, and Maintenance month 1
Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLA, Los Angeles
UCSD, Division of Blood and Marrow Transplantation, Moores Cancer Center, La Jolla
University of California Davis Comprehensive Cancer Center, Sacramento
UCSF Comprehensive Cancer Center, San Francisco
Collaborators (1)
Leadiant Biosciences, Inc.
INDUSTRY
University of California, San Diego
OTHER