13 December 2023

A personalised therapy approach for chronic lymphocytic leukaemia (CLL) has significantly improved patient survival, British researchers have reported.

Researchers at the University of Leeds used regular blood testing to monitor the response of patients to treatment in a phase III trial.

They reported their findings to the annual meeting of the American Society of Hematology in San Diego, California, at the weekend. The research has also been published in the New England Journal of Medicine.

The researchers say the improvements were greatest among patients with poor responses to standard treatments, often linked to genetic variants.

The study, FLAIR, has taken place in more than 100 hospitals across the UK. The researchers say that more than 95% of patients were in remission three years after beginning treatment, involving ibrutinib and venetoclax.

1,509 patients have been randomised to four treatment groups during the trial. In the results presented at ASH, two treatment arms were compared.

260 patients received ibrutinib and venetoclax, for durations tailored to responses shown in blood and bone marrow tests (twice as long as time taken to achieve minimal residual disease). Of these, 12 patients saw their disease progress, including nine who died.

Out of 263 on standard treatment – fludarabine-cyclophosphamide-rituximab (FCR) – 75 suffered progression of disease and 25 of these lost their lives, the researchers reported.

Study leader Professor Peter Hillmen, professor of experimental haematology, said: “The results of the FLAIR Trial, led by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds, are exceptional and herald a change in the way chronic lymphocytic leukaemia will be treated.

“FLAIR has been a huge collaborative effort over the last decade by the UK’s leading CLL specialists and by the haematology teams in over 100 hospitals throughout the UK. The participation of patient groups, individual patients and their families were critical to delivering such progress particularly through the challenges of the pandemic.”

He added: “Our findings show that, for this group of patients, the treatment is very effective at tackling their disease and is well tolerated by them. This means that patients on our trial had better outcomes while also enjoying a better quality of life during their treatment.

“Most patients treated with the new combination have no detectable leukaemia in their blood or bone marrow by the end of treatment which is better than with previous treatments and is very encouraging.”

Dr Iain Foulkes, from Cancer Research UK, which funded the study, added: “We are delighted to see these results from the FLAIR trial which show the importance and effectiveness of tailoring cancer treatment to the individual patient. Not only this, but the trial has found a way to do so without requiring frequent bone marrow tests which are more invasive and can be painful.”


Munir T, Cairns DA, Bloor A, Allsup D, Cwynarski K, Pettitt A, Paneesha S, Fox CP, Eyre TA, Forconi F, Elmusharaf N, Kennedy B, Gribben J, Pemberton N, Sheehy O, Preston G, Schuh A, Walewska R, Duley L, Howard D, Hockaday A, Jackson S, Greatorex N, Girvan S, Bell S, Brown JM, Webster N, Dalal S, de Tute R, Rawstron A, Patten PEM, Hillmen P, for the National Cancer Research Institute Chronic Lymphocytic Leukemia Subgroup. (2023) “Chronic lymphocytic leukemia therapy guided by measurable residual disease.” New England Journal of Medicine, doi: 10.1056/NEJMoa2310063.

Link: https://www.nejm.org/doi/10.1056/NEJMoa2310063

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