A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia.

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.

• Authors: William Donnellan, Jesus G Berdeja, Diana Shipley, Edward R Arrowsmith, David Wright, Scott Lunin, Richard Brown, James H Essell, Ian W Flinn
• Journal: The oncologist (Oncologist) Vol. 22 Issue 10 Pg. 1156-e111 (10 2017) ISSN: 1549-490X [Electronic] England
• PMID: 28687625 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: ©AlphaMedPress; the data published online to support this summary is the property of the authors.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• ofatumumab

Topics

• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage, pharmacology, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (administration & dosage, pharmacology, therapeutic use)
• Female
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy, pathology)
• Male
• Middle Aged