Describing the real world use of bosutinib in the UK and Netherlands
Research type
Research Study
Full title
A retrospective observational research study to describe the real world use of bosutinib in the UK and Netherlands
IRAS ID
186108
Contact name
Jane Apperley
Contact email
Sponsor organisation
Pfizer Ltd
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Chronic myeloid leukaemia (CML) is a rare malignant haematological disease. Tyrosine kinase inhibitors (TKI) are drugs often used to treat the disease. Imatinib was the first type of TKI to be introduced and is currently the drug of first choice. Newer TKIs including nilotinib, dasatinib and bosutinib have now been developed and led to a significant improvement in survival, such that the 5-year overall survival in patients diagnosed in the chronic phase is reported as over 85%.
Bosutinib (Bosulif®) is a 2nd generation TKI which received European Medicines Agency (EMA) marketing authorisation in March 2013. Bosutinib is used for the treatment of adult patients previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. The aim of this study is to characterise the use of bosutinib in clinical practice in the UK and the Netherlands.
The study is an international, multicentre, observational, retrospective research study of patients with CML involving review of medical records. It will take place in approximately 8 centres in the UK and 2 in the Netherlands. Data from approximately 100 patients will be collected.
Retrospective data will be collected from patients’ medical records by trained data collectors. Patients will be invited to consent to allow a researcher access to their medical records for the purpose of data collection. Since no consent can be obtained where the patient is deceased and contacting the relatives of deceased patients is likely to cause distress, in these situations members of the direct care team will collect the data from identifiable records and provide anonymised data to researchers for analysis.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0263
Date of REC Opinion
28 Aug 2015
REC opinion
Further Information Favourable Opinion