346
Participants
Start Date
August 26, 2010
Primary Completion Date
January 3, 2018
Study Completion Date
December 26, 2018
Ofatumumab
Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.
Bendamustine infusion
Bendamustine 100 mg/vial, injection
Ofatumumab and Bendamustine infusions (Arm A)
Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.
Bendamustine infusion (Arm B)
Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).
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Lead Sponsor
Novartis Pharmaceuticals
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