What will happen if I choose to take part?
First visit
If you decide to take part in IMPROVE, we will ask you to attend your local hospital and provide your written consent. Then we will record your height and weight and take a blood sample to check your current immunity to COVID-19. We will also ask about the number of previous COVID-19 vaccinations you have had, and ask you to complete a short questionnaire about your condition and your quality of life.
Once you have joined the study, we will contact you each week by either text or a phone call reminding you to let us know when you receive an appointment for your COVID-19 vaccination. Your vaccine will be given to you through a routine vaccination appointment at your GP practice or walk-in centre and can be any of the COVID-19 vaccines recommended in the UK.
Note: The study team will not know the date of your vaccination until you tell us.
Which group will I be in?
Once you notify us of your vaccination date, a computer will decide by chance which of the 2 study groups you are in; neither you, or your study team will be able to choose which group you will be in. This process is called randomisation. One group will continue their BTKi as usual, and the other group will pause their BTKi treatment for 3 weeks (21 days).
To remind you what to do with your BTKi drug, we will contact you by text or telephone one week before your vaccination date, at the time of your vaccination, and two weeks after your vaccination date. This last message will remind those pausing BTKi to re-start their treatment.
Second visit
We will ask you to come to the clinic 3 weeks after your COVID-19 vaccination. We will ask you about your vaccination, and take a blood sample to check your COVID-19 immunity. You will also be asked to complete the questionnaire about your CLL and how you are again. If you happened to receive the ‘flu vaccine at the same time as your COVID-19 vaccination, we will also record this and assess your ’flu immunity from the same blood sample you provide.
Third and final visit
This will take place 12 weeks after your COVID-19 vaccination. We will take a blood sample to check your current COVID-19 immunity, and ask you to complete the same questionnaire as at previous visits again.
Additional visits
We will also ask 20 participants who are cared for in London and Birmingham if they could donate 2 additional blood samples at the time of the vaccination and 1 week after. This is to help us understand more about how taking and pausing BTKi can influence any immune response found. The extra samples are being requested from London and Birmingham participants due to the close location of the laboratories where the blood sample will be sent to.
What are the risks and benefits of taking part?
This research will help us to understand if pausing BTKi therapy for 3 weeks can improve immune responses to vaccination and to see how well this is tolerated. We will also share with you your COVID-19 antibody levels from each of the 3 blood tests you provide (before, 3 and 12 weeks after the vaccination) and a brief explanation of what they mean.
We routinely pause BTKi therapy for patients who are needing elective surgery and usually this does not cause any serious problems, however, occasionally patients can feel unwell stopping their medication and their symptoms from CLL can return e.g sweats and fevers.
If this happens, please let your local team know and notify the Trials Unit on telephone number 0808 175 1455.
These symptoms resolve quickly after re-starting the medication. There are no known longer term risks for pausing BTKi treatment for 3 weeks.
Does it matter if I've had COVID-19 infection in the past?
It does not matter if you have had COVID-19 infection in the past, and all ages, genders, races and ethnicities are welcome to take part.
