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12th February 2021

Important announcement on the UK FLAIR trial

One of the arms of the UK FLAIR trial has used Ibrutinib. This has been instrumental in gaining approval for Ibrutinib in the UK. However, the trial was scheduled to run for six years only, and many patients are now at or near the end of this period and are faced with stopping treatment. This prospect has raised serious concern about possible complications or relapse.

For several months we have been working with the pharmaceutical company and Prof Peter Hillmen, who is leading the trial, in order to try to find a solution for all of the CLL patients involved.

We are very pleased to be able to announce that we now have clarity regarding future treatment for patients who may be at the 6-year stage. This statement (dated 4th Feb 2021) is from Prof Peter Hillmen

FLAIR and STATIC trial update

Background: The development of ibrutinib has had a major positive impact for patients with chronic lymphocytic leukaemia (CLL). However the “life-long” use of such drugs can create some problems, such as the emergence of side effects over time and the risk that the CLL develops resistance to ibrutinib. Continuous ibrutinib may not be the best approach and there is evidence to suggest it might be better to give drugs such as ibrutinib intermittently. It is known that when patients with CLL stop ibrutinib for toxicity it is an average of just under 2 years before they progress. “Intermittent” ibrutinib use means that once a patient is in a good remission there is a pause in treatment, which might last for some considerable time, until there are early signs of CLL reappearing (before the patient has any symptoms). At this point ibrutinib would be re-started until the patient was back in remission. Intermittent treatment has the potential to reduce side effects as well as reducing resistance to therapy.

FLAIR Trial: The FLAIR Trial is the current UK trial for patients with CLL needing treatment for the first time. In FLAIR patients are scheduled to stop ibrutinib after 6 years by which time they should be in deep remissions so that we might anticipate a long time before progression.

STATIC Trial is designed to answer the question whether continuous ibrutinib until CLL progression or intermittent treatment with ibrutinib is better. Patients receiving ibrutinib in FLAIR will be eligible to enter STATIC. These patients coming from FLAIR who have been taking ibrutinib for 6 years will have the option of any of the following:

1) Enter STATIC and be randomised to continuous ibrutinib or intermittent ibrutinib (note this is not stopping ibrutinib permanently but pausing ibrutinib – patients will re-start in STATIC at the first sign of their CLL reappearing)

2) Enter STATIC and elect to stay on ibrutinib continuously (individual patient choice)

3) Not enter STATIC and remain off ibrutinib in follow-up in FLAIR (the patient will still remain under regular follow-up with their trials team)

It is hoped that patients would mostly be randomised in STATIC between continuous or intermittent ibrutinib. Patients in STATIC will be closely monitored to make sure that we identify if there are any group of patients who progress quickly after pausing ibrutinib so that such patients are not subsequently entered into STATIC.

Previously treated patients with CLL in STATIC:

In addition to patients from FLAIR (“previously untreated patients”) STATIC will also be open for patients with previously treated CLL who are in a good remission on ibrutinib. These “previously treated” patients will be able to enter STATIC without previously being in FLAIR.

When will STATIC open? Under ordinary circumstances it would take about 9 months to open a trial like STATIC – there is a lot of work to do! Therefore it is unlikely that STATIC will open before September 2021 (although we are trying to expedite this). This means that patients entering FLAIR before September 2015 will have come off ibrutinib before STATIC is open. These patients will pause ibrutinib after 6 years but will be offered entry into STATIC when it is open having the same choices – either be randomised or elect to continue (in this case re-start) ibrutinib. The only exception is that if any of these patients have signs of returning CLL then they will be able to elect to continue ibrutinib in STATIC but will not be randomised.”

We believe that this is a very reassuring statement and hope it helps to allay any fears and worries. Hospital consultants should have this information very soon, and will be able to discuss with you what action you may wish to take.

Prof Hillmen will be able to take questions on this and other CLL related topics in our next webinar on 18 March 2021.

CLL Support trustees