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iwCLL 2025 | The IMPROVE trial: paused versus continuous BTKi therapy during vaccination in patients with CLL
Helen Parry, MBChB, MSc, PhD, MRCP, FRCPath, University of Birmingham, Birmingham, UK, discusses the findings of the IMPROVE trial, which investigated the impact of pausing BTK inhibitor (BTKi) therapy during COVID-19 vaccination in patients with chronic lymphocytic leukemia (CLL). Dr Parry highlights that the study found no difference in vaccine response between patients who paused BTKi therapy for 3 weeks and those who continued treatment, with some patients experiencing significant side effects when pausing treatment. This emphasizes the need for continued BTKi therapy during vaccination, and this recommendation has been incorporated into the recently published 2025 British Society for Haematology (BSH) Guidelines for the treatment of CLL. This interview took place at the biennial International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2025 in Krakow, Poland.
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Transcript
So the IMPROVE trial was a national trial that we ran in the UK and it was funded by the NIHR and is now published in Lancet Haematology. So this trial came about during the COVID pandemic when we realised that patients who were taking covalent Bruton’s tyrosine kinase inhibitors were amongst the groups that had the poorest response to vaccination and there was some anecdotal data at the time, just small numbers, to suggest that actually if we paused the covalent BTKi at the time that we provided the vaccination that that might improve their immunity...
So the IMPROVE trial was a national trial that we ran in the UK and it was funded by the NIHR and is now published in Lancet Haematology. So this trial came about during the COVID pandemic when we realised that patients who were taking covalent Bruton’s tyrosine kinase inhibitors were amongst the groups that had the poorest response to vaccination and there was some anecdotal data at the time, just small numbers, to suggest that actually if we paused the covalent BTKi at the time that we provided the vaccination that that might improve their immunity. And so we set about this randomized control trial that recruited 99 patients at multiple sites and we asked patients if they were in the randomized arm to pause their drug for three weeks around the time that they got the vaccination and they actually received the vaccination on day seven of that pause and then had a further two weeks off drug to allow time for a germinal center reaction and antibody formation. And the other comparative arm, control arm, was to continue the drug throughout their vaccination.
And the results found that there was no difference between the two arms, and with that, we obviously have been trying to pull that apart. So a third of patients after five doses of COVID vaccine were still unable to respond to vaccination, and we think that that may be important in terms of determining who may also be at risk of infections and coming into hospital whilst taking a BTKi. And so whilst it was a negative readout in the sense that it didn’t advise that we should be pausing, it’s given us quite a clear indication that patients should continue on their BTKi at the time that they receive vaccination. So that has now been built into our very recently published British Society of Haematology guidelines. And the other thing to just point out with the study was that we did find amongst the 99 patients, a couple of patients who actually had quite significant symptoms upon pausing their drug. So quite a clear message, really, without that additional benefit gained from having no improved immunity, but there was a risk of some side effects from stopping the drug. So categorically, we have come out saying that we do not think that patients should be pausing their drug, and hopefully that’s clarified that question.
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