The impact of pausing BTKi therapy and responsiveness of vaccination in blood cancer patients: A randomised controlled study – the IMPROVE study

Not Applicable

Completed

• Conditions: Chronic lymphocytic leukaemia; Cancer

• Registration Number: ISRCTN14197181
• Lead Sponsor: niversity of Birmingham

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-20
• Last Update Posted: 29 January 2024
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-SARS-CoV-2 spike (S) protein receptor binding domain (RBD) antibody levels measured using Roche Elecsys® electrochemiluminescence assay (Roche S) at baseline and at 3 weeks post-SARS-CoV-2 vaccination