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Phase 1b study of venetoclax-obinutuzumab in previously untreated and relapsed/refractory chronic lymphocytic leukemia

Blood Mar 18, 2019

Flinn IW., et al. - Researchers undertook this single-arm, open-label, phase 1b study to determine the maximum tolerated dose (MTD) of venetoclax when given with obinutuzumab in addition to its safety and tolerability in patients with relapsed/refractory (R/R) or previously untreated (1L) chronic lymphocytic leukemia (CLL). They administered venetoclax-obinutuzumab for 6 cycles, followed by venetoclax monotherapy until disease progression (R/R) or fixed-duration 1 year of treatment (1L). Outcomes from 50 R/R and 32 1L patients suggest no dose-limiting toxicities. venetoclax 400 mg combined with obinutuzumab was established in the dose-finding study; it showed an acceptable safety profile in R/R and 1L CLL. They observed high response rates with deep remissions in R/R and 1L CLL using venetoclax-obinutuzumab, irrespective of cytogenetic risk factors.
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