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Full study title: A multi-centre randomised controlled trial examining the effects of temporarily pausing Bruton Tyrosine Kinase inhibitor therapy to coincide with SARS-CoV-2 vaccination and its impact on immune responses in patients with Chronic Lymphocytic Leukaemia
PURPOSE OF THE STUDY
Chronic lymphocytic leukaemia ('CLL') is a blood cancer that affects white blood cells called lymphocytes. It is the commonest adult leukaemia, with 3,800 people diagnosed each year in the UK. It is more common in people aged over 60. Currently some 31,900 people have CLL in the UK.
CLL develops slowly and there is no cure. People with CLL have a weakened immune system and are susceptible to infections. These infections can be severe and life-threatening. New drugs called Bruton Tyrosine Kinase inhibitors (BTKi) have transformed the outlook for CLL patients, however, they stop the immune response to vaccination. BTKi drugs need to be taken daily and continuously. They are sometimes paused if a patient needs an operation. In the UK, they are used at all stages of treatment.
The purpose of this study is to investigate whether pausing the use of these BTKi drugs for a total of three weeks around the time of having the COVID vaccine improves the antibody response, and whether this is well tolerated.
