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Phase II study of combination obinutuzumab, ibrutinib, and venetoclax in treatment-naïve and relapsed or refractory chronic lymphocytic leukemia

Journal of Clinical Oncology Nov 03, 2020

Rogers KA, Huang Y, Ruppert AS, et al. - Among patients with treatment-naïve (n = 25) and relapsed or refractory (n = 25) chronic lymphocytic leukemia, this phase II study was performed to evaluate a combination regimen of obinutuzumab, ibrutinib, and venetoclax for a total of 14 cycles in order to ascertain the response to therapy as well as the safety. The rate of complete remission with undetectable minimal residual disease via flow cytometry in both the blood and bone marrow 2 months following finish of therapy was assessed (primary endpoint), which was estimated to be 28% in both groups. In treatment-naïve patients and in relapsed or refractory patients, an overall response rate of 84% and 88%, respectively, was reported at that time. A median follow-up of 24.2 months and 21.5 months in these respective groups revealed that the median progression-free and overall survival times were not yet reached. It was revealed that time-limited treatment that led to deep remissions was afforded by the combination regimen of obinutuzumab, ibrutinib, and venetoclax. Phase III cooperative group trials are now examining this combination regimen.

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