Timing of HD-MTX CNS Prophylaxis in Diffuse Large B-cell Lymphoma
Research type
Research Database
IRAS ID
287691
Contact name
Matthew Wilson
Contact email
Research summary
HD-MTX CNS Prophylaxis Registry
REC name
West of Scotland REC 4
REC reference
20/WS/0114
Date of REC Opinion
2 Oct 2020
REC opinion
Further Information Favourable Opinion
Data collection arrangements
This database will store information on patients previously treated for a specific type of lymphoma ('diffuse large B-cell lymphoma) with a particular type of chemotherapy (high dose methotrexate). Patients treated between the years 2010-2019 will be identified from large oncology centres. Clinicians who routinely have access to healthcare records will record information from the subjects once identified. This information will be routinely stored data, including information on patient age, sex, lymphoma stage, laboratory results, chemotherapy scheduling, side effects, disease relapse, and death. No names, initials or hospital identification numbers will be stored. Patients will be allocated a unique, anonymised study number and will be identified by this study number only in any analyses. The data will be sent to the study administrators and be stored on an encrypted, password protected document on a secure server on an NHS computer/hard drive. Only approved database administrators will have access to the data. The data will not be used/accessed on any personal computers or devices.
Research programme
The data in this registry will be used to address a very important clinical problem in diffuse large B-cell lymphoma. Central nervous system (CNS) relapse is rare but is almost universally fatal. There is significant variation world wide in methods used to reduce the risk of CNS relapse - this reflects the lack of high quality data to inform practice. We previously carried out a UK wide multicentre audit comparing 2 different approaches for delivering high-dose methotrexate as CNS prophylaxis. We found important differences in toxicity and impact on primary chemotherapy between the groups. However, the numbers were insufficient to make firm conclusions on whether either method was superior in terms of reducing risk of CNS relapse. We plan to extend data collection to other centres in the UK and also to centres across the world, to create a large dataset with more power to detect potential differences in CNS relapse and survival between the groups. The findings from this study have the potential to influence practice given the lack of randomised trials addressing this specific question. We will also use the data to determine if the different approaches for delivering HD-MTX differ with regards to toxicity and impact on primary treatment ('R-CHOP' chemoimmunotherapy). The data will be analysed with the ultimate goal being presentation at a large scientific meeting, and publication. The Beatson West of Scotland Cancer Centre will lead on data analysis, presentation and publication.
Research database title
HD-MTX CNS Prophylaxis Registry
Establishment organisation
NHS Greater Glasgow and Clyde (Beatson West of Scotland Cancer Centre)