Tissue collection for biomarkers determining resistance to Ibrutinib.
Research type
Research Study
Full title
Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia - Stage 1.
IRAS ID
154071
Contact name
Sunil Iyengar
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Research summary
With the recent FDA approval of Ibrutinib for the management of relapsed/refractory MCL and CLL, we are entering an exciting phase in the management of these conditions. A crucial next step is to validate biomarkers that predict clinical activity of Ibrutinib in order to tailor therapy and maximise benefit to patients. The recently opened named patient supply (NPS) of ibrutinib in the UK provides an excellent window of opportunity for these studies.
We have set up a collaboration with Professor Simon Rule (Plymouth) and Dr George Follows (Cambridge), who are carrying out a prospective data collection study for patients entered on to the NPS. With the help of our collaborators we will be able to identify centres in the NHS for collection of samples. Patients entered on to the NPS will be provided an information sheet and research specific consent form following which samples from consenting patients will be transferred to the Royal Marsden Hospital (RMH) for storage. Samples will be logged and tracked using a secure database. Samples for research will be collected at the same time as routine sampling and therefore no additional sampling will be required. For each patient, consent will be obtained for pre-treatment, progression as well as any diagnostic samples taken or stored and patients will require to be on the study for at least 24 months from the start of their treatment. The collection will end 24 months after the last patient commences treatment on the NPS.
Once we have an idea of the number of patient samples we can collect, the second stage of this study will be initiated and will involve molecular screening of samples at RMH for biomarkers of resistance. The data from the molecular studies will then be correlated with the clinical response data from our collaborators for clinical validation.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1158
Date of REC Opinion
5 Aug 2014
REC opinion
Further Information Favourable Opinion