Recent first-line randomized controlled trials (RCTs) for patients with diffuse large B-cell lymphoma (DLCBL) have demonstrated negative results which, according to Robert Andrew Harkins and colleagues, “may be due in part to onerous eligibility criteria limiting enrollment of poor-risk patients who require immediate treatment.” Therefore, Harkins and collaborators surveyed lymphoma experts in the United States to define essential and non-essential enrollment criteria in an effort to improve the clinical diversity in cohorts of modern RCTs evaluating first-line DLBCL treatments.
The investigators initially collated the enrollment criteria of 19 RCTs conducted during the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) “era” to identify common eligibility criteria for inclusion in a Delphi-method survey. A total of 451 eligibility criteria covering 51 criterion categories were tabulated from the R-CHOP RCTs. The study’s contributors then surveyed lymphoma clinical trial experts from eight academic medical centers on essential and unnecessary eligibility criteria.
A total of 29 clinical investigators were invited to respond to the first round of the survey. Seventeen experts completed the round one questionnaire (response rate = 58.6%), and 15 of those completed the round two survey (88.2%). Lastly, all round one participants reviewed the finalized recommendations for eligibility criteria.
Ultimately, the authors reported that they defined consensus recommendations for 31 improved eligibility criteria, “including threshold values for 10 quantitative eligibility criteria aimed at facilitating enrollment of a clinical diverse study population in first-line DLBCL RCTs designed to improve standard of care therapy.” Validation of these updated enrollment criteria guidelines is warranted after future RCTs on first-line DLBCL treatments are conducted.