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An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
BeiGene Australia Pty Ltd
This is an open-label, randomized active control study of BGB-3111 plus obinutuzumab versus obinutuzumab alone in subjects with relapsed or refractory follicular lymphoma. Randomization is 2:1 and subjects will be stratified by the number of prior lines of therapy (2 - 3 vs > 3) and rituximab-refractory status. In Arm A of the study, approximately 140 subjects will receive an oral 80mg dose of BGB-3111 twice a day and 1000mg of Obinutuzumab, administered intravenously on days 1, 8 and 15 of the cycle, followed by 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. In Arm B, 70 patients will receive Obinutuzumab alone. For both groups, 1 cycle = 28 days. The study will evaluate the efficacy, as measured by overall response rate by independent review, safety and tolerability. Pharmacokinetic profile of BGB-3111 and obinutuzumab combination therapy will also be evaluated.