Open AccessA Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia
Author(s) -
Donnellan William,
Berdeja Jesus G.,
Shipley Diana,
Arrowsmith Edward R.,
Wright David,
Lunin Scott,
Brown Richard,
Essell James H.,
Flinn Ian W.
Publication year - 2017
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2017-0236
Subject(s) - medicine , ofatumumab , regimen , dosing , anesthesia , placebo , chronic lymphocytic leukemia , surgery , urology , leukemia , alternative medicine , pathology
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.