34
Participants
Start Date
July 31, 2013
Primary Completion Date
December 31, 2015
Study Completion Date
March 31, 2017
Ofatumumab
The first dose of ofatumumab administered on Day 1 will be 300 mg to minimize infusion reactions. If the initial 300 mg dose of ofatumumab is well-tolerated, without occurrence of any infusion-associated AEs of \>= grade 3, on Day 3 ofatumumab will increase to 1000 mg IV. If the Day 3 dose was well-tolerated (i.e., no infusion-associated AE \>= grade 3), on Day 8 the ofatumumab dose will escalate to 2000 mg IV. To achieve the primary endpoint for this study, 20% of the 2000 mg ofatumumab dose only will be administered over the first 30 minutes and if tolerated the remaining 80% of the dose will be infused over the remaining 1.5/hours of each treatment. Ofatumumab doses, weeks 3-8, will remain at 2000 mg IV with no further dose escalations. If the Day 8 (Week 2) dose is tolerated all subsequent doses may be infused in the same manner.
Florida Cancer Specialists-North, St. Petersburg
Florida Cancer Specialists-South, Fort Myers
Tennessee Oncology PLLC, Nashville
Chattanooga Oncology Hematology Associates, Chattanooga
Oncology Hematology Associates, Cincinnati
Colorado Blood Cancer Institute, Denver
Collaborators (2)
GlaxoSmithKline
INDUSTRY
Novartis
INDUSTRY
SCRI Development Innovations, LLC
OTHER