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Inhibitors of Bruton tyrosine kinase (BTK) or B-cell lymphoma 2 (BCL2) protein are highly active as single agents in the treatment of chronic lymphocytic leukemia (CLL). Now, investigators report a phase II industry-sponsored trial of ibrutinib plus venetoclax in previously untreated patients with poor-risk features: del(17p), TP53 mutation, del(11q), unmutated IGHV, or age >65. Ibrutinib 420 mg/day was administered for 3 months, after which venetoclax was initiated with a 4-week dosing ramp-up (to mitigate risk for tumor lysis syndrome) to a target dose of 400 mg/day. Combination therapy was continued for 24 four-week cycles.
Of 80 patients enrolled, 88% achieved complete remission after 12 cycles; 61% were minimal residual disease (MRD)–ne…