Summary
Diffuse large B-cell lymphoma (DLBCL) is the most common type of aggressive non-Hodgkin lymphoma (NHL), accounting for 30-40% of all NHL cases.
To assess the risk for DLBCL, doctors use tools like the International Prognostic Index (IPI), aaIPI, and NCCN-IPI. These tools help identify high-risk patients but are not good at spotting those at "ultra-high-risk" (UHR) of treatment failure within two years of diagnosis.
This study is a nationwide platform that offers real-time, centralised risk assessment for people with large B-cell lymphoma (LBCL) who are treated with frontline immuno-chemotherapy. This may help doctors make better treatment decisions, provide more accurate prognoses, and advance molecular and imaging techniques in Australia and New Zealand.
The study also aims to identify ultra high-risk LBCL patients for clinical trials of new treatments, creating an efficient and cost-effective framework for future lymphoma trials.
Who is it for?
You may be eligible for this study if you are aged 18 years or older and have been diagnosed with LBCL.
Study details
LBCL patients will commence standard of care immunotherapy regimen. They will have some tests (a FDG/PET scan and/or a MRD assay) at baseline, cycle 4, cycle 6, and 3 months after treatment ends.
People with a positive disease result will be referred to relevant treatment arms of this study, depending on meeting the relevant criteria. A positive disease will be based on centralised baseline tumour sequencing, centralised delta standardised uptake value (SUV) quantification / Deauville score, and measurable residual disease (MRD) testing.
A UHR LBCL patient population will be identified and referred to a relevant therapeutic arm of this study to test novel treatments such as CAR-T cell infusion.
This research aims to evaluate the feasibility of achieving faster turnaround rates for centralised MRD and FDG-PET reviews, to identify an UHR population to get them on appropriate treatment sooner.
By meeting meeting the following benchmarks in real time, the study will significantly contribute to the field by enhancing the speed and accuracy of prognostic processes:
- MRD analysis and report turnaround must be completed within 21 days from sample collection.
- FDG-PET scan reports must be ready within 7 days for SUV/Deauville score at C4D15, C6D15, and 3 months after the end of treatment.