Status:
UNKNOWN
Tissue Collection for Biomarkers Determining Resistance to Ibrutinib
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
University Hospital Plymouth NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Mantle Cell Lymphoma
Chronic Lymphocytic Leukaemia
Eligibility:
All Genders
Brief Summary
Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.
Detailed Description
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 vali...
Eligibility Criteria
Inclusion
- All patients entered into the Ibrutinib NPS for relapsed refractory MCL and CLL in the UK and who consent to have biological material stored for this research will be included in the study. Patients who have already commenced treatment with Ibrutinib will also be eligible whether or not they are responding.
Exclusion
- All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-
- Samples not satisfying the criteria for diagnosis of CLL or MCL.
- Samples with evidence of high grade transformation (e.g. Richter's transformation of CLL).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02267590
Start Date
October 1 2014
End Date
October 1 2016
Last Update
October 17 2014
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT