New Reference: Ibrutinib and Rituximab for CLL


  • Study

    Phase III, randomized,controlled, multicenter, open-label trial (FLAIR)
    Treatment naive CLL–small lymphocytic lymphoma (SLL)
    İbrutinib + Rituximab (n=386) vs. FCR (n=385)




  • Efficacy

    mPFS: NR vs.67 mos, p<0.0001
    4-year PFS: 85.6% vs. 73%
    mOS: NR vs. NR
    4-year OS: 92.1% vs.93.5%



  • Safety

    Grade≥3 AEs: Anemia (4% vs. 14%), white blood cell decreased (14% vs.54%), sepsis (2% vs.12%), fever (1% vs.10%)



  • Lancet Oncol VOL 24, ISSUE 5, P535-552, MAY 2023

    Ibrutinib and rituximab versus fludarabine, cyclophosphamide, and rituximab for patients with previously untreated chronic lymphocytic leukaemia (FLAIR): interim analysis of a multicentre, open-label, randomized, phase 3 trial

    http://doi.org/10.1016/S1470-2045(23)00144-4

    Reviewed by Elvin Chalabiyev, MD on May 20, 2023