![]() ![]() This result was consistent for gender, age or stage. The hazard ratio (HR) for PFS for I+V vs FCR is 0.13 (95% CI: p<0.0001 Fig). At a median 43.7 months there were 87 progressions - 75 FCR and 12 I+V. IGHV unmutated (≥98% homology to germline) in 56.9%, 37.6% IGHV mutated and 5.5% Subset 2. In I+V after 2 mo I, V was added with a 4-week dose escalation to 400mg/day and then I+V for up to 6 years with duration of I+V defined by MRD (65yo) and 40.9 % Binet Stage C. Here we report the planned analysis of I+V vs FCR. ![]() FLAIR was adapted in 2017 to add 2 arms, I alone and I+V compared to FCR. Patients (pts) with >20% 17p deleted cells were excluded. Methods: FLAIR (ISRCTN01844152) is a phase III, multicentre, randomised, controlled, open, parallel group trial for untreated CLL. We hypothesized that I+V is more effective than FCR in CLL and that treatment duration personalised using MRD response would optimize outcome. However, mathematical disease modelling and Phase II studies favor defining duration of I+V according to individual patient sensitivity. A Phase III trial comparing I+V (15 months ) with chlorambucil-obinutuzumab led to the approval of I+V. This is supported both by in vitro studies and Phase II trials in which I+V results in high proportions of measurable residual disease (MRD) negativity. ![]() I and V target two key pathophysiological pathways in CLL and should be synergistic. ![]() Introduction: Ibrutinib (I), an irreversible Btk inhibitor, and venetoclax (V), a Bcl-2 inhibitor, improve CLL outcomes in trials compared to chemoimmunotherapy. ![]()
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