![]() 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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