Annals of hematology

Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma.

PMID 25630297


The efficacy/tolerability of bendamustine, a unique alkylator, plus ofatumumab, a human anti-CD20 monoclonal antibody, was evaluated for previously untreated indolent B cell non-Hodgkin's lymphoma (NHL). The study investigated whether the overall response rate (ORR) for bendamustine-ofatumumab was similar to historical bendamustine-rituximab ORRs (≥90xa0%). In this multicenter, open-label, single-arm, phase II study, patients received six planned 28-day cycles of bendamustine (90xa0mg/m(2) on days 1 and 2 of each cycle) and ofatumumab (300xa0mg on day 1, 1000xa0mg on day 8 of cycle 1, and on day 1 of subsequent cycles). The primary outcome was ORR. Secondary objectives included safety and tolerability. Exploratory evaluations included percentage of patients with positive baseline [(18)F]fluorodeoxyglucose positron emission tomography (FDG-PET) scans who converted to negative postbaseline and quality of life (QOL) scores. The treated/safety analysis population received ≥1 dose of either therapy. The bendamustine-ofatumumab ORR was 90xa0% (95xa0% confidence interval, 77.8-96.6) in 49 treated patients (67xa0% complete response, 22xa0% partial response). No patients had progressive disease. Bendamustine-ofatumumab was acceptably tolerated. All 49 patients had ≥1 adverse event, the most common being nausea (61xa0%), fatigue (55xa0%), and infusion-related reactions (45xa0%, all but 1 occurring during cycle 1). The proportion of patients whose FDG-PET scans converted to negative postbaseline was 88xa0%. Changes in QOL scores were minor. In patients with treatment-naive, indolent B cell NHL, bendamustine-ofatumumab exhibited a high degree of activity (90xa0% ORR), comparable with historical bendamustine-rituximab ORRs (≥90xa0%), and was adequately tolerated ( identifier: NCT01108341).