OVERVIEW
- Front-Line therapy in CLL: Assessment of Ibrutinib-containing Regimens (FLAIR) demonstrated improved progression-free survival for ibrutinib and rituximab (IR) compared with fludarabine, cyclophosphamide and rituximab (FCR) in previously untreated chronic lymphocytic leukaemia (CLL).
- This report presents the secondary end-point of health-related
quality of life (HR-QoL).
STUDY DETAILS
FLAIR was a phase 3, open-label, randomised trial across 101 hospitals. IR was administered for up to 6 years and FCR for six cycles. Participants completed European Organisation for Research and Treatment of Cancer Quality of Life C30 Questionnaire (EORTC-QLQ-C30), QLQ CLL Module (QLQ-CLL16), three-level EQ-5D (EQ-5D-3L) and EQ5D visual analogue (EQ-VAS) at baseline and follow-up. Overall, scales were comparable between treatment groups, indicating that continuous IR does not compromise HR-QoL.
Primary financial support was from Cancer Research UK. Unrestricted educational grants from Janssen, Pharmacyclics and AbbVie supported trial coordination and laboratory studies. Study drug (ibrutinib) was provided by Janssen. This work was also supported by Core Clinical Trials Unit Infrastructure from Cancer Research UK (C7852/A25447).
TITLE OF PUBLICATION
Patient-reported health-related quality of life in previously untreated chronic lymphocytic leukaemia: Results from the randomised phase 3 FLAIR trial comparing ibrutinib–rituximab versus fludarabine–cyclophosphamide–rituximab
AUTHORS
David J. Allsupp, David A. Cairns, E. Faye Samy, Lelia Duley, Adrian Bloor, Abraham Varghese, David Meads, Bryony Dawkins, Sean Girvan, Dena R. Howard, Anna Hockaday, Julia M. Brown, Sharon Jackson, Natasha Greatorex, Phoebe Templeton, Michael Tupper, David Phillips, Sonam Yaqub, Di Mortimer, David Stones, Piers E. M. Patten, Andrew Rawstron, Peter Hillmen, Talha Munir.
Faye Samy undertook the analysis and contributed to the published manuscript.
Publication Reference
Br J Haematol. 2026;00:1–12 | Publication Year 2026
