Validation of US Consensus Eligibility Criteria for Front-Line DLBCL Trials

Identifying patients eligible for front-line clinical trials with diffuse large B-cell lymphoma (DLBCL) has been challenging, primarily due to increasingly stringent inclusion criteria and the limitations of the International Prognostic Indices in identifying patients who are unlikely to achieve long-term remission after standard treatment. We aimed to assess the impact of using improved eligibility criteria established through a US-based Delphi-method survey to identify real-world DLBCL patients eligible for clinical trials. Additionally, we developed a predictive model to assess the individual risk of trial-eligible patients with an online calculator. Of 5341 potential trial candidates identified from the Danish Lymphoma Registry, 4063 patients (76.1%) were trial-eligible if the recommended eligibility criteria were applied. Among excluded patients, 7.9% would be excluded due to inadequate organ function. To develop a predictive model for progression-free survival, we randomly divided the population into a training and a validation cohort (3:1 ratio). Then, the Delphi Trial Prognostic Index (DTPI) was developed based on eight clinical and laboratory variables, demonstrating superior performance compared to the International Prognostic Indices. Our prediction model, which incorporates less restrictive eligibility criteria and utilizes an online calculator, was designed to more accurately predict outcomes for potential candidates eligible for first-line clinical trials.