Observational chart review study of TKI's in patients with CML
Research type
Research Study
Full title
An Observational Retrospective Chart Review of Sequencing of Second-Generation Tyrosine Kinase Inhibitors (TKIs) in Patients With Chronic Phase Philadelphia Chromosome–Positive CML Who Fail Second-Line TKI Therapy
IRAS ID
248968
Contact name
Jennifer Louise Byrne
Contact email
Sponsor organisation
Incyte Biosciences UK
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Leukemia is a blood cancer.In most types of leukaemia, abnormal white blood cells are made in the bone marrow. These cells can get into the bloodstream and circulate round the body.Chronic myeloid leukemia (CML) is characterised by the dysregulated production and proliferation of white blood cells . A specific chromosomal abnormality known as the “Philadelphia chromosome” is present in 95% of people with CML.
Treatment options for patients with CML include hematopoietic cell transplant, disease control with tyrosine kinase inhibitors (TKI’s) or palliative therapy with cytotoxic agents. In CML, TKIs target the abnormal protein that causes uncontrolled CML cell growth and block its function, causing the CML cells to die.
First- and second-generation TKIs (defined as imatinib [first generation], nilotinib, dasatinib, and bosutinib [second generation]) are all recommended in the UK as an initial treatment option for most patients with previously untreated CML in the chronic phase. For patients who have failed second-generation TKI therapy, there is little evidence that cycling through further second-generation TKIs is of benefit.
The aim of this study is to generate real world evidence on how patients with CML are sequenced through second-generation TKIs in the UK from third and subsequent lines of treatment. The study will also evaluate the clinical value of cycling through second-generation TKIs to understand the standard of care and treatment pathway.
This is a multicentre, observational, non-interventional, retrospective chart note review study which will take place in the UK only. No additional data will be collected during this study and all data will be pseudonymised. Data will be collected from up to 20 centres in the UK and approximately 150 patients and the data collection will cover the time period of June 2013 to June 2017. Data collection will take place for approximately 6 months. Incyte Biosciences UK are sponsoring the study.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/1691
Date of REC Opinion
15 Oct 2018
REC opinion
Favourable Opinion