HD-MTX CNS Prophylaxis Registry

• Research type

  Research Database

• IRAS ID

  358946

• Research summary

  HD-MTX CNS Prophylaxis Registry

• REC name

  West of Scotland REC 4

• REC reference

  25/WS/0077

• Date of REC Opinion

  12 Jun 2025

• REC opinion

  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. Due to uncertainty around the optimal delivery of high-dose methotrexate CNS prophylaxis (HD-MTX) in this setting (timing, cycle number and dose), we previously created a database of 1,384 patients from 37 centres worldwide. Analyses from this database have now been presented at international meetings and published in peer-reviewed journals (Wilson et al, Blood 2022; Wilson et al, Am J Hematol 2023). In summary, we demonstrated that ‘intercalated’ delivery of HD-MTX was associated with increased toxicity and risk of chemotherapy delay, but importantly showed no benefit in terms of CNS relapse reduction compared to delivery at end of treatment. There were also concerningly high rates of CNS relapse observed overall, despite all patients receiving HD-MTX. Our work from this database has been recognised world-wide as practice-changing in the field. There is now significant uncertainty in the lymphoma community around the utility of HD-MTX as CNS prophylaxis in DLBCL. Guidelines have been re-written which suggest its use should be limited to only those patients with so-called ‘ultra high-risk’ characteristics. The aim of the proposed study is to create a larger dataset of such patients by merging our aforementioned HD-MTX timing dataset with additional cases from a number of sites who contributed to another large study. This additional sub-study will not involve any collection of new data. The proposed plan is to identify sites who submitted data to a separate study (Lewis et al, JCO 2023).

• Research database title

  HD-MTX CNS Prophylaxis Registry

• Establishment organisation

  Beatson West of Scotland Cancer Centre

• Establishment organisation address

  1053 Great Western Road

  G12 0YN