Mantle Cell Lymphoma Clinical Trial
Official title:
Clinical Validation of Biomarkers Determining Resistance to BTK Inhibition With Ibrutinib in Mantle Cell Lymphoma & Chronic Lymphocytic Leukaemia - Stage 1
Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.
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.
The investigators 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 the investigators 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 pretreatment, 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.
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Time Perspective: Prospective
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