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

niversity of Birmingham0 个研究点目标入组 99 人开始时间: 2022年9月20日最近更新: 2024年1月29日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37770269/ (added 29/09/2023)

•1. Aged 18 years and over
•2. Confirmed diagnosis of chronic lymphocytic leukaemia
•3. Taking oral NICE-approved BTKi therapy (Acalabrutinib or Ibrutinib) for at least 12 months since the date of initiation of therapy
•4. Has achieved complete remission (CR; including CR with incomplete marrow recovery), partial remission (PR; including nodular PR or PR with lymphocytosis) or stable disease by the International Workshop on CLL (iwCLL) response criteria
•5. Considered able to temporarily pause (suspend) BTKi therapy for three weeks without the risk of a substantial increase in disease activity
•6. Anticipated to take BTKi over the next 4 months (i.e. not in the STATIC trial arm where therapy is stopped)
•7. Willing to accept either study arm allocation
•8. Able to give informed consent
•9. Eligible for a planned vaccination for COVID-19

•1. Insufficient time for applying the intervention prior to the planned COVID-19 vaccination.
•2. Diagnosed with alternative conditions requiring treatment with BTKi
•3. Treated with anti-CD20 antibody therapy in the last 18 months or planning to start it
•4. Concurrent immune suppressive treatments in the last 3 months specifically: methotrexate, ciclosporin, BCL-2 inhibitors, azathioprine, mycophenolate, prednisolone, biologic agents
•5. Any contraindication to COVID-19 vaccination
•6. Richter’s transformation requiring active therapy
•7. Radiotherapy or cancer chemotherapy in the last 6 months
•8. Active solid organ cancer (people with skin cancer or those cured of solid organ cancer are eligible)
•9. Receiving or has received in the past 6 months immunoglobulin replacement therapy
•10. Receiving or has received in the past 6 months monoclonal antibody against COVID-19 spike protein

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