Journal article
Improving eligibility criteria for first-line trials for patients with DLBCL using a US-based Delphi-method survey
Blood advances, Vol.6(9), pp.2745-2756
05/10/2022
DOI: 10.1182/bloodadvances.2021006504
PMCID: PMC9092417
PMID: 35100356
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.
Details
- Title: Subtitle
- Improving eligibility criteria for first-line trials for patients with DLBCL using a US-based Delphi-method survey
- Creators
- R Andrew Harkins - Emory UniversitySharvil P Patel - Emory UniversityMichelle J Lee - Morehouse School of MedicineJeffrey M Switchenko - Emory UniversityStephen M Ansell - Mayo ClinicNancy L Bartlett - Washington University in St. LouisKristie A Blum - Emory UniversityAmanda F Cashen - Washington University in St. LouisCarla Casulo - University of RochesterJonathan W Friedberg - University of RochesterPatrick B Johnston - Mayo ClinicBrad S Kahl - Washington University in St. LouisJohn P Leonard - Weill Cornell MedicineBrian K Link - University of IowaIzidore S Lossos - University of MiamiPeter Martin - Cornell UniversityMatt J MaurerNeha Mehta-Shah - Washington University in St. LouisPatrick M Reagan - University of Rochester Medical CenterJason R Westin - The University of Texas MD Anderson Cancer CenterJean L Koff - Emory UniversityChristopher R Flowers - The University of Texas MD Anderson Cancer Center
- Resource Type
- Journal article
- Publication Details
- Blood advances, Vol.6(9), pp.2745-2756
- DOI
- 10.1182/bloodadvances.2021006504
- PMID
- 35100356
- PMCID
- PMC9092417
- NLM abbreviation
- Blood Adv
- ISSN
- 2473-9529
- eISSN
- 2473-9537
- Grant note
- P30 CA138292 / NCI NIH HHS K24 CA208132 / NCI NIH HHS TL1 TR002382 / NCATS NIH HHS UL1 TR002378 / NCATS NIH HHS
- Language
- English
- Date published
- 05/10/2022
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359583102771
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