ELECTRIC: qualitative observational study in UK patients with CLL

• Research type

  Research Study

• Full title

  Qualitative, cross-sectional observational study exploring the experience of patients prescribed venetoclax+rituximab or Bruton’s tyrosine kinase inhibitors for chronic lymphocytic leukaemia in clinical practice in the UK (ELECTRIC)

• IRAS ID

  307599

• Contact name

  Dima El-Sharkawi

• Contact email

  dima.el-sharkawi@rmh.nhs.uk

• Sponsor organisation

  Abbvie UK

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  1 years, 2 months, 30 days

• Research summary

  This is a qualitative, cross-sectional observational study that will be conducted in approximately ten National Health Service (NHS) centres in the United Kingdom (UK).

  Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults. Venetoclax + rituximab (Ven+R) and Bruton’s tyrosine kinase inhibitors (BTKi) are approved treatment options for CLL that has ‘relapsed’ (i.e., responded to therapy initially but stopped responding after a period of time) or is ‘refractory’ (i.e., did not respond) to the first-line of therapy. Ven+R has a fixed treatment duration of 24 months, whereas BTKi requires continuous treatment.

  This research aims to better understand the CLL treatment experience with Ven+R or BTKi at different time points in the treatment journey; this will include symptoms related to CLL, adverse effects experienced on and off-therapy, the impact of treatment on symptom relief, treatment burden, the impact of the type of treatment administration, and the perceived value of fixed treatment duration or continuous therapy. The results will help to support treatment decision-making.

  Each patient will participate in a single (60-90 minute) qualitative interview exploring the CLL treatment experience. A retrospective chart review will also be conducted to collect data on patient demographics, clinical characteristics, CLL treatments, adverse effects and hospital visits, from patients’ medical records.

  The population for the study is adult patients diagnosed with relapsed or refractory CLL who received treatment with Ven+R or BTKi as part of their standard clinical care.
  
  There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or clinical visits will be required. The study is expected to recruit 140 patients in total.

  Lay summary of study results: The Sponsor is currently finalising the lay summary and will provide this to the HRA in due course.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Observational studies do not require summary results. We do post a redacted CSR synopsis on: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.abbvieclinicaltrials.com%252Fstudy%252F%253Fid%253DP23-486%2FNBTI%2FOWPAAQ%2FAQ%2F35ad690b-b40d-46c5-965b-b66b618c9a7a%2F1%2FDQDOrMWBRi&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C871b9417ca294497eff908de00306c50%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638948405165132113%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=tQTjCPQlhuXqszcgGrTPKp2F9sTB9wrVr5NxEY1FJNk%3D&reserved=0
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
  If yes, describe or provide URLs to disseminated materials:
  If pending, date when dissemination is expected: 31/10/2025
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected: 31/10/2025
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: This is done on a case-by-case basis, and specific information would have to come from the direct team that manages those requests.
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: Not applicable - this was a non-interventional study and did not involve the collection or use of tissue samples.
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• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  22/PR/0289

• Date of REC Opinion

  15 Mar 2022

• REC opinion

  Favourable Opinion