A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia
William Donnellan, Jesus G Berdeja, Diana Shipley, Edward R Arrowsmith, David Wright, Scott Lunin, Richard Brown, James H Essell, Ian W Flinn, William Donnellan, Jesus G Berdeja, Diana Shipley, Edward R Arrowsmith, David Wright, Scott Lunin, Richard Brown, James H Essell, Ian W Flinn
Abstract
Lessons learned: Ofatumumab infusion reactions can be diminished by escalating the dose rate in individual patients in sequential infusions.
Background: Ofatumumab (OFA) is a fully humanized, anti-CD20 antibody approved for use in chronic lymphocytic leukemia (CLL). The recommended administration requires long infusion times. We evaluated an accelerated infusion regimen of 2 hours.
Methods: The first dose of OFA (300 mg) was given on week 1 day 1 starting at 3.6 mg/hour and doubling every 30 minutes until a rate of 240 mg/hour was reached. If tolerated, the second dose (1,000 mg) was given on week 1 day 3 starting at 50 mg/hour and doubling every 30 minutes until a rate of 800 mg/hour was reached. If tolerated, the third dose (2,000 mg) was given on week 2 day 1 at 800 mg/hour over the first 30 minutes and, if tolerated, at 1,068 mg/hour over the next 90 minutes (goal infusion time: 120 minutes). Subsequent OFA infusions were administered weekly in the same manner for 8 weeks, and then monthly for 4 months.
Results: Thirty-four patients were treated. Most infusion-related reactions occurred during the first and second infusion. Eighty-seven percent (87%) of patients finished the third infusion within 15 minutes of the planned 2 hours and only one had an infusion reaction.
Conclusion: Using this stepped-up dosing regimen, a rapid infusion of OFA is safe and well tolerated.
Trial registration: ClinicalTrials.gov NCT01848145.
©AlphaMedPress; the data published online to support this summary is the property of the authors.
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Source: PubMed