Trial Information: This is a Phase III comparative clinical trial of rituximab (Rituxan) and ofatumumab (Arzerra) monotherapy in follicular lymphoma patients who have relapsed following prior therapy with rituximab. 516 patients will be recruited and randomized to rituximab or ofatumumab, in both cases four weekly treatments followed by an additional treatment every two months, for eight months. Patients must have relapsed following a prior chemotherapy regimen that included rituximab.
Background Information: Both rituximab and ofatumumab are anti-CD20 monoclonal antibodies, which target an important protein on the surface of B-cells (including malignant cells). Ofatumumab is a newer drug and may have some advantages over rituximab. It binds to a different part of the CD20 molecule, which may be more effective. It is also a fully human antibody (whereas rituximab is chimeric mouse-human), which might lead to less frequent and less severe allergic reactions.
Thus far, like this study, most clinical trials have focused on ofatumumab in the relapsed setting. This is standard for clinical trials, but realistically most relapsed patients with follicular lymphoma have already been treated with an anti-CD20 drug (namely rituximab), and therefore one would expect less response in this setting than if ofatumumab were used in initial treatment. Certain recent trials suggest the response rate to ofatumumab in rituximab-refractory patients may be as low as 11%, meaning that ofatumumab may be slightly more effective than rituximab but that it is not particularly effective when rituximab fails (and vice-versa).
Canadian Sites: Kitchener, ON; Moncton, NB; Quebec City, QC.
For more information, see ClinicalTrials.gov.
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