ISRCTN14197181
Completed
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic lymphocytic leukaemia
- Sponsor
- niversity of Birmingham
- Enrollment
- 99
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37770269/ (added 29/09/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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