447
Participants
Start Date
March 31, 2010
Primary Completion Date
February 28, 2014
Study Completion Date
November 30, 2014
OFATUMUMAB + DHAP
3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.
RITUXIMAB + DHAP
3 cycles of treatment will be administered. Each cycle will last 21 days. rituximab dose: cycle 1, day 1 - 375 mg/m2; cycle 1, day 8 - 375 mg/m2; cycle 2, day 1 and cycle 3, day 1 - 375 mg/m2. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.
GSK Investigational Site, Dublin
GSK Investigational Site, James Street
GSK Investigational Site, Vienna
GSK Investigational Site, Budapest
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GSK Investigational Site, Vienna
GSK Investigational Site, Brussels
GSK Investigational Site, Copenhagen
GSK Investigational Site, Leuven
GSK Investigational Site, Hasselt
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Lead Sponsor
GlaxoSmithKline
INDUSTRY