Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma

Abstract

Despite initial responses > 90% with fludarabine and rituximab-based regimens, patients with chronic lymphocytic leukemia (CLL) invariably relapse and require further treatment. Ofatumumab and bendamustine have each shown efficacy in relapsed/refractory CLL with overall response rates (ORRs) of 58% and 76%, respectively. Given excellent data with bendamustine and rituximab in relapsed/refractory CLL/small lymphocytic lymphoma (SLL), this phase II study evaluated the combination of ofatumumab and bendamustine in previously treated patients. Patients received ofatumumab 300 mg intravenously (IV) day − 7, followed by ofatumumab 1000 mg IV day 1 and bendamustine 70 mg/m² days 1 and 2 of each 28-day cycle. Patients received 4–6 cycles depending on number of prior therapies, as long as well-tolerated or until progression. Of 10 patients enrolled, the ORR was 40% and complete response rate was 20%. The median progression-free and overall survivals were 8.1 months and 16.2 months. Three patients developed Richter transformation. The study was closed early due to unexpected adverse events including infusion-related reactions, infection and neurotoxicity.

Keywords::

• Ofatumumab
• bendamustine
• CLL
• SLL

Acknowledgements

The study was sponsored by the Lombardi Comprehensive Cancer Center at Georgetown University Hospital in collaboration with GlaxoSmithKline, Inc. and Cephalon, Inc.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.