Improving eligibility criteria for first-line trials for patients with DLBCL using a US-based Delphi-method survey

R. Andrew Harkins, Sharvil P. Patel, Michelle J. Lee, Jeffrey M. Switchenko, Stephen M. Ansell, Nancy L. Bartlett, Kristie A. Blum, Amanda F. Cashen, Carla Casulo, Jonathan W. Friedberg, Patrick Bruce Johnston, Brad S. Kahl, John P. Leonard, Brian K. Link, Izidore S. Lossos, Peter Martin, Matt J. Maurer, Neha Mehta-Shah, Patrick M. Reagan, Jason R. WestinJean L. Koff, Christopher R. Flowers

Research output: Contribution to journalArticlepeer-review

Abstract

Recent first-line randomized controlled trials (RCTs) for patients with diffuse large B-cell lymphoma (DLBCL) have shown negative results, which may be due in part to onerous eligibility criteria limiting enrollment of poor-risk patients who require immediate treatment. We conducted a Delphi-method survey with lymphoma experts in the United States to define recommendations for essential and potentially unnecessary enrollment criteria for modern first-line DLBCL RCTs aimed at increasing clinical diversity of ensuing study groups. We first tabulated enrollment criteria from 19 DLBCL RCTs spanning the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) era to identify common eligibility criteria from prior DLBCL RCTs for inclusion in the Delphi-method survey. We tabulated 451 total eligibility criteria comprising 51 criterion categories across 19 first-line DLBCL RCTs in the R-CHOP era. We then surveyed lymphoma clinical trial experts representing 8 academic medical centers in the United States regarding essential and unnecessary eligibility criteria for modern DLBCL RCTs. Seventeen of 29 invited clinical investigators completed the round-1 questionnaire (response rate, of 58.6%), 15 of 17 round-1 participants (88.2%) completed the round-2 survey, and all round-1 participants reviewed finalized recommendations for eligibility criteria for modern first-line DLBCL RCTs. We defined consensus recommendations for 31 modernized eligibility criteria including threshold values for 10 quantitative eligibility criteria aimed at facilitating enrollment of a clinically diverse study population in first-line DLBCL RCTs designed to improve standard-of-care therapy.

Original languageEnglish (US)
Pages (from-to)2745-2756
Number of pages12
JournalBlood Advances
Volume6
Issue number9
DOIs
StatePublished - May 10 2022

ASJC Scopus subject areas

  • Hematology

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