MCL Biobank Observational Study
Research type
Research Study
Full title
Establishing a Biobank and Database as a National Resource for Characterising Indolent and Aggressive forms of Mantle Cell Lymphoma, an Observational Study.
IRAS ID
145772
Contact name
Simon Rule
Contact email
Sponsor organisation
Plymouth Hospitals NHS Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
‘Research Summary’
Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin's lymphoma; a cancer of the lymphocytes (white blood cells) that occurs when the growth of these cells is out of control. MCL is a relatively rare, usually aggressive cancer for which there is currently no known cure. Many patients are treated as soon as they are diagnosed because they generally have a poor prognosis. However, our experience tells us that there is a sub-set of patients that have a less aggressive form of the disease. They can remain asymptomatic, sometimes for years. These patients need not be treated with systemic chemotherapy straight away and ‘watching and waiting’ does not affect the outcome at all.
There are currently no tests that can tell us which patients have indolent behaving disease at diagnosis. Knowing this will be really helpful in finding the best way to treat people with this disease in the future. The only way that we can really be sure which type of MCL a patient has, is to observe what happens to them over the next few years.
We will collect baseline blood and saliva samples, diagnostic biopsy material and clinical information from patients who are newly diagnosed with MCL. These samples will be stored in a Biobank. After this, patients will not directly be involved as the information we need to collect can be found in the medical notes. We aim to recruit 300 participants over 3 years.
Once the study is completed, we will know which patients have indolent MCL and which patients have aggressive MCL. We will then study the stored samples to try to identify and understand the differences between indolent and aggressive forms of MCL.
‘Summary of Results’
Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin's lymphoma; a cancer of the lymphocytes (white blood cells) that occurs when the growth of these cells is out of control. MCL is a relatively rare, usually aggressive cancer for which there is currently no known cure. Many patients are treated as soon as they are diagnosed because they generally have a poor prognosis. However, our experience tells us that there is a sub-set of patients that have a less aggressive form of the disease. They can remain asymptomatic, sometimes for years. These patients need not be treated with systemic chemotherapy straight away and 'watching and waiting' does not affect the outcome at all. There are currently no tests that can tell us which patients have indolent behaving disease at diagnosis. Knowing this will be really helpful in finding the best way to treat people with this disease in the future. To be sure which type of MCL a patient has, we set up the MCL Biobank study to observe what happens to them over the course of a few years.
593 participants were recruited from 68 sites in England, Wales and Scotland between 9th February 2015 and 31st October 2019. Baseline blood and saliva samples, diagnostic biopsy material and clinical information were collected from patients who were newly diagnosed with MCL. These samples are being stored at the University of Liverpool's GCPLab Facility. There was no further involvement by the participants after the samples were taken. Data was collected via the participants' medical notes. Now the study has ended, we are analysing the data to confirm which patients have indolent MCL and which patients have aggressive MCL. The samples that are being stored in the GCPLab facility are also being studied to try to identify and understand the differences between indolent and aggressive forms of MCL.
The primary outcome of the study has been presented at the European Haematology Association (EHA) meeting in June 2024 and a paper is being prepared. The main findings are 38% of enrolled patients were selected for a watchful waiting strategy, and the median time to treatment or death in this group was 594 days. 26% of patients remained under a watchful waiting strategy at a median follow up of 4 years. Of patients selected for a watchful waiting strategy, their median survival from initiation of treatment was similar to those who had immediate treatment.
Further work is ongoing to characterise the role of PET scanning in the prognostication of these patients. A unique biobank for MCL has been established in the UK (at the University of Liverpool UK CLL Biobank), as intended. Arrangements for handing legitimate requests for access to the banked data and/or sample material are being finalised.REC name
Wales REC 7
REC reference
14/WA/1192
Date of REC Opinion
9 Oct 2014
REC opinion
Favourable Opinion