IMPROVE study: The IMpact of Pausing BTKi therapy in Blood Cancer

• Research type

  Research Study

• Full 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

• IRAS ID

  319057

• Contact name

  Helen Parry

• Contact email

  h.m.parry@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• ISRCTN Number

  ISRCTN14197181

• Duration of Study in the UK

  1 years, 7 months, 30 days

• Research summary

  Chronic lymphocytic leukaemia ('CLL') is a blood cancer that affects the 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. They 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.

  What question will the study answer?
  Does pausing BTKi inhibitor drugs for a total of three weeks before and after having the COVID vaccine improve the antibody response and is this well tolerated?

  We will invite adults with well-controlled CLL who have been taking a BTKi inhibitor for at least a year, and are due to have a COVID vaccine, to take part in IMPROVE. We will recruit 120 people at up to 10 NHS hospital sites. Half (60) will be asked to pause their treatment for three weeks: one week before their vaccine, and two weeks after. The other half (60) will continue their treatment as usual. We will take blood samples to check everyone’s vaccine response three weeks and 12 weeks after vaccination. We will also monitor their CLL and ask participants to complete questionnaires about their quality of life.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  22/YH/0226

• Date of REC Opinion

  9 Sep 2022

• REC opinion

  Favourable Opinion