A trial examining the effects of pausing BTKis to coincide with SARS-CoV-2 vaccination and its impact on immune responses in CLL patients

[gardening-girl]

Trial registration number ISRCTN14197181

bmjopen.bmj.com/content/13/...

This study aims to determine in patients with chronic lymphocytic leukaemia (CLL) if a 3-week pause in Bruton tyrosine kinase inhibitor therapy (BTKi) starting 1  week before delivery of SARS-CoV-2 vaccine booster, improves vaccine immune response when compared with continuation of BTKi.

Methods and analysis An open-label, randomised controlled superiority trial will be conducted in haematology clinics in approximately 10 UK National Health Service (NHS) hospitals. The sample size is 120, randomised 1:1 to intervention and usual care arms. The primary outcome is anti-spike-receptor binding domain (RBD) antibody level at 3 weeks post-SARS-CoV-2 booster vaccination. Secondary outcomes are RBD antibody levels at 12 weeks postbooster vaccination, participant global assessments of disease activity, blood films, full blood count and lactate dehydrogenase levels, impact on quality of life, self-reported adherence with request to temporarily pause or continue BTKi, T cell response against spike protein and relative neutralising antibody titre against SARS-CoV-2 viral variants. Additionally, there will be an investigation of any effects in those given influenza vaccination contemporaneously versus COVID-19 alone.

I'd sign up for this trial if I could!

[Kwenda]

See also these pages..

tandfonline.com/doi/abs/10....

healthunlocked.com/cllsuppo...

improve.octru.ox.ac.uk/

birmingham.ac.uk/news/2023/...

Dick

[gardening-girl in reply to Kwenda]

Dick, clearly I'd missed the previous references to this trial, and thought that this Sept. 28 publication was an announcement of the trial! Thanks for setting me straight. Even more ridiculous is the fact that the trial isn't even even recruiting any more.

[Kwenda in reply to gardening-girl]

What we all really need is to see the results of this UK trial published, as many people are now taking the COVID booster vaccinations for the coming winter season...

Certainly in the USA it seems that anyone taking a BTKi should withhold the drug for some time just before and after the COVID vaccination.

I have reached out to my UK consultant, but have not yet heard back.

[Kwenda]

I wrote earlier this comment:- I have reached out to my UK consultant, but have not yet heard back..

Just heard back, and my consultant's official reply is that since the IMPROVE trial has not reported, he cannot formally agree with any plan to stop the Acalabrutinib.

This might be formally recommended at a later date, based upon published results.

However his pragmatic reply, is that " he has no strong objection."

Dick