111
Participants
Start Date
November 10, 2015
Primary Completion Date
July 17, 2019
Study Completion Date
November 21, 2022
Blinatumomab
15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Dexamethasone
10 mg/m\^2/day intravenous (IV) on Days 1-6
Vincrisitne
1.5 mg/m\^2/day IV on Days 1 and 6
Daunorubicin
30 mg/m\^2 IV over 24 hours on Day 5
Methotrexate
1 g/m\^2 IV over 36 hours on Day 1
Ifosfamide
800 mg/m\^2 IV for 1 hour on Days 2-4
PEG-asparaginase
1000 U/m\^2 IV for 2 hours or intramuscularly (IM) on Day 6
Erwinia-asparaginase
In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses
Research Site, Brussels
Research Site, Vienna
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Research Site, Westmead
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Research Site, Newcastle upon Tyne
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Research Site, Sutton
Lead Sponsor
Amgen
INDUSTRY