Validation of <scp>US</scp> Consensus Eligibility Criteria for Front‐Line <scp>DLBCL</scp> 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.

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Publication Details

Journal
European Journal Of Haematology
Published
2025-12-08
DOI
https://doi.org/10.1111/ejh.70072
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
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article

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

Jelena Jelicic, Michael Roost Clausen, Rasmus Rask Kragh Jørgensen, Anne Ortved Gang et al.
European Journal Of Haematology
Lymphoma Diagnosis and Treatment
article

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

Jelena Jelicic, Michael Roost Clausen, Rasmus Rask Kragh Jørgensen, Anne Ortved Gang, Robert Schou Pedersen, Thomas Stauffer Larsen, Zoran Bukumirić, Tarec Christoffer El‐Galaly, Karen Juul‐Jensen, Mikkel Runason Simonsen, Ahmed Ludvigsen Al‐Mashhadi, Christian Bjørn Poulsen, Peter C. Brown
article en

Abstract

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.

European Journal Of HaematologyVol. 116(3)
University of Copenhagen (DK), University of Southern Denmark (DK), Aarhus University (DK), Aalborg University Hospital (DK), Odense University Hospital (DK), Aarhus University Hospital (DK), Copenhagen University Hospital (DK), Rigshospitalet (DK), University of Belgrade (RS), Zealand University Hospital (DK), Vejle Sygehus (DK), Regionshospitalet Herning (DK), Lillebaelt Hospital (DK), Aalborg University (DK)
Openalex Percentile: Top 45%
Lymphoma Diagnosis and Treatment
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