TASTER -TArgeting STEm cell Resistance
Research type
Research Study
Full title
TASTER- TArgeting STEm cell Resistance An umbrella adaptive randomised multi–arm screening phase II trial for patients with 2nd/3rd generation TKI resistant chronic myeloid leukaemia
IRAS ID
250158
Contact name
Karen Carty
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2018-001843-29
ISRCTN Number
ISRCTN68270067
Duration of Study in the UK
5 years, 7 months, 28 days
Research summary
Chronic Myeloid Leukaemia(CML) is treated with drugs called Tyrosine Kinase Inhibitors, also known as ‘TKIs’. These drugs, five in total, are targeted therapies designed to selectively block specific proteins that enable the leukaemic cells to divide and increase in number. Treatment with TKI therapies in chronic phase CML is very effective in the majority of cases. However, 10 to 20% of patients do not achieve an optimal response to therapy as recommended by the European LeukemiaNet. To help us solve the puzzle why some patients don’t have optimal response to TKI, we want to identify ‘gene signatures’, within the leukaemic cells of patients who have not achieved an optimal response to TKI therapies. A ‘gene signature’ describes a group of genes (in a cell) that when they are combined express a unique pattern which identifies a particular group of cells in a medical condition, e.g. resistant cells. A simple analogy is to imagine a ‘gene signature’ as a fingerprint-like identifier that helps describe a particular sub-group of patients and may help to explain why they do not achieve good responses to TKI therapies. It is hoped that by finding such ‘gene signatures’ we can clearly identify those patients more likely to respond well to a combination of their current TKI with one of the new drugs being studied. The purpose of this study is to test whether one or more of these new drugs, when combined with a currently available TKI, is effective in improving clinical responses. We want to map ‘gene signatures’ from patients enrolled in the study so that we can treat them more effectively without increasing side effects, by combining TKI therapy with one of the two new study drugs. Patient in chronic or accelerated phase CML who have not achieved optimal response to TKI will be eligible.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0529
Date of REC Opinion
28 May 2019
REC opinion
Further Information Favourable Opinion