Protocol v3.0
The amendment is to implement an updated protocol (current version 1.1 dated 19-Jul-2019 updated to version 3.0 dated 25-Jan-2023). The changes include:
• Addition of treatment regimen (“TEMIRI”) following induction, in the case where patients do not respond to induction chemotherapy. This allows these patients to continue on the HR-NBL2 trial.
• Addition of temozolomide and irinotecan as IMPs.
• Addition of tumour pathology analysis. Please note that this translational study is not carried out in the UK as part of the HR-NBL2 trial but patients can contribute to these biological studies by giving consent to participate in the CCLG research.
• Addition of neuropsychology assessment. Please note that this study is not carried out in the UK.