New Reference: Ibrutinib and Rituximab for CLL
Study
Phase III, randomized,controlled, multicenter, open-label trial (FLAIR)
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Treatment naive CLL–small lymphocytic lymphoma (SLL)
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İbrutinib + Rituximab (n=386) vs. FCR (n=385)
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Efficacy
mPFS: NR vs.67 mos, p<0.0001
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4-year PFS: 85.6% vs. 73%
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mOS: NR vs. NR
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4-year OS: 92.1% vs.93.5%
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Safety
Grade≥3 AEs: Anemia (4% vs. 14%), white blood cell decreased (14% vs.54%), sepsis (2% vs.12%), fever (1% vs.10%)
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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
Reviewed by Elvin Chalabiyev, MD on May 20, 2023