P22-905

• Research type

  Research Study

• Full title

  Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe

• IRAS ID

  332558

• Contact name

  Nishil Patel

• Contact email

  nishil.patel3@nhs.net

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Clinicaltrials.gov Identifier

  EU/1/16/1138/001-7, Product Reference; EMEA/H/C/004106/XX, Procedure Number; EUPAS104768, EU PAS Register Number

• Duration of Study in the UK

  0 years, 8 months, 0 days

• Research summary

  This study will be a cross-sectional survey of knowledge of the risks and safe use of venetoclax as outlined in the patient card among adult patients who have recently received venetoclax for treatment of chronic lymphocytic leukaemia (CLL) per standard of care. Patients will be identified through a diverse selection of medical practices representing haematologists who prescribe venetoclax across at least 5 European countries. Patients will be invited to participate by their physician and will be asked to complete a one-time self-administered structured questionnaire.
  The study will target 200 eligible patients (approximately 30-50 per country) to allow reasonable precision around estimates of patients' knowledge of the PC.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  23/EM/0230

• Date of REC Opinion

  25 Jan 2024

• REC opinion

  Further Information Favourable Opinion