Retrospective study to describe the real world UK use of TKIs in CML
Research type
Research Study
Full title
Real world UK use of Tyrosine Kinase Inhibitors (TKIs): A Retrospective description of manaGement pathways, clinical responses and compliance with 2013 European LeukemiaNeT (ELN) recommendations for Chronic Myeloid Leukemia (CML) – the UK TARGET-CML study
IRAS ID
184847
Contact name
Adam Mead
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
Tyrosine Kinase Inhibitors (TKIs) are drugs which are often used to treat chronic myeloid leukemia (CML). Imatinib was the first TKI available but newer TKIs (including nilotinib and dasatinib) have recently been developed which have been shown to be more effective than imatinib in patients with newly diagnosed CML. In 2013 new guidelines for the management of CML were published by the European LeukemiaNet (ELN) panel. The guidelines make recommendations for the use of TKIs in CML and provide updated definitions of treatment response.
This study aims to describe how TKIs are used to treat CML in normal UK NHS practice, the level of response to treatment and compliance with the 2013 ELN guidelines. The study will benefit patients and the NHS by evaluating current clinical practice against recently updated evidence based recommendations; this will help to identify areas for change to ensure the best patient outcomes and most effective use of NHS resource.
The study is a multicentre, observational, retrospective research study of patients with CML involving review of medical records. It will take place in approximately 15 centres in England, Scotland, Wales and Northern Ireland and data from between 120 and 150 patients will be collected.
Retrospective data will be collected from patients’ medical records by trained data collectors. All living 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
HSC REC A
REC reference
15/NI/0170
Date of REC Opinion
4 Aug 2015
REC opinion
Favourable Opinion