FLAIR version 2.0
Research type
Research Study
Full title
FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib-containing Regimes
IRAS ID
126738
Contact name
Peter Hillmen
Contact email
Sponsor organisation
University of Leeds
Eudract number
2013-001944-76
ISRCTN Number
ISRCTN01844152
Duration of Study in the UK
10 years, 6 months, 30 days
Research summary
Chronic Lymphocytic Leukaemia (CLL) is the most common haematological malignancy in the UK. The most effective therapy for treating CLL is the combination of fludarabine, cyclophosphamide and rituximab (FCR). FCR is the standard therapy for patients who are fit for relatively intensive therapy however FCR is associated with significant early and late toxicity mainly with infections and bone marrow suppression. As knowledge of CLL increases new therapies are being developed to treat the disease and the most promising new approach uses therapies that target signalling through the B-cell receptor (BCR) which is expressed on CLL cells and leads to CLL cell growth. Bruton's tyrosine kinase is a critical component of BCR signalling and inhibiting it by use of ibrutinib, a leading agent in the new class of therapies, leads to impressive response rates with minimal toxicity in patients with CLL who have not responded well to previous chemotherapy. Ibrutinib monotherapy (I) is already widely used following phase III trials in relapsed refractory disease, and has shown convincing superiority over chlorambucil in unfit or elderly patients with previously untreated CLL. It is hypothesised that the addition of venetoclax to ibrutinib will reduce MRD levels faster and more effectively than I alone or IR, and therefore improving the outcomes, allowing the duration of therapy to be reduced, leading to a reduction in long-term toxicities and an overall cost saving.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0085
Date of REC Opinion
15 Apr 2014
REC opinion
Favourable Opinion