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Phase 1b study of obinutuzumab, ibrutinib, and venetoclax in relapsed and refractory chronic lymphocytic leukemia

Blood Aug 21, 2018

Rogers KA, et al. - Given that obinutuzumab, ibrutinib, and venetoclax have shown significant clinical activity in chronic lymphocytic leukemia (CLL), but combining venetoclax with other active agents may increase the risk of tumor lysis syndrome, researchers tested a fixed-duration regimen using sequentially administered obinutuzumab followed by ibrutinib (cycle 2) and venetoclax (cycle 3) for a total of fourteen 28-day cycles to minimize this risk. In 12 patients with relapsed or refractory CLL, they tested three dose levels of venetoclax and identified the FDA approved doses of all three agents for use in the combination. They reported no clinically significant tumor lysis syndrome was seen. As per their observation, 92% was the overall response rate, with a complete remission or complete remission with incomplete marrow recovery seen in 42%. Overall, they found that this regimen was safe and tolerable in CLL and induces strong responses.

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