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Treatment with the BCL-2 inhibitor venetoclax combined with an anti-CD20 monoclonal antibody has shown high response rates in patients with relapsed or refractory chronic lymphocytic leukemia (CLL; e.g., NEJM JW Oncol Hematol Mar 21 2018 and N Engl J Med 2018; 378:1107). However, analysis of this regimen in the frontline setting has been limited.
To address this issue, investigators conducted an industry-funded, multicenter, prospective, open-label, randomized, phase 3 trial (GAIA–CLL13) of treatment with venetoclax in 926 previously untreated, medically fit adults with advanced-stage CLL; those with del(17p) or TP53 mutations were ineligible. Patients were randomized to one of four treatment groups:
Chemo-immunotherapy with fludarabine, cycl…