iwCLL 2025 | The Phase III STATIC trial: stopping therapy to avoid treatment resistance in CLL

So the STATIC trial is a trial which is developed on the background of this concept that if we give continuous therapy to our patients they are going to develop resistance. So we have patients who were treated with Ibrutinib-based therapy in the FLAIR study and there are two parts of the trial. One part of the trial is looking at frontline patients coming out of the FLAIR study. All of these patients had six years of ibrutinib therapy and most patients are in very good remission. What we’ve done is that half of the patients will receive continuous ibrutinib, so no change, and the other half will stop therapy. The patients who will stop therapy will be continuously monitored clinically and if there is a sign of clinical relapse or their white cell count starts to go up then they will be able to reinitiate therapy. So the primary endpoint of the study is if they fail this approach. But essentially what we’re trying to look at is whether intermittent therapy is as good as continuous therapy and maybe better than continuous therapy in the long term. We also have a relapsed/refractory cohort, where patients who had three years of ibrutinib or acalabrutinib will again be randomized in a similar fashion to continuous therapy versus an intermittent approach. And this trial is already recruiting in the UK and we’re nearly a quarter of the way into recruitment into the study at this moment in time.

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