{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T22:21:30Z","timestamp":1793830890655,"version":"4.6.1"},"reference-count":29,"publisher":"American Society of Hematology","issue":"6","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,2,5]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Clinical trial eligibility criteria select a target population and reduce anticipated risks for participants but may unnecessarily limit participation both overall and differently across demographic groups. We previously abstracted eligibility criteria for 190 phase 2\/3 acute myeloid leukemia (AML) trials and used US Food and Drug Administration and professional society guidance on modernizing criteria to develop alternative, safety-based eligibility criteria for each trial. In this analysis, these trial- and safety-based eligibility criteria sets were applied to a retrospective cohort of 2226 newly diagnosed patients across 8 hospitals to assess the impact on eligibility. Eligibility proportions increased from a median of 47.9% with trial-based criteria to 84.2% with safety-based criteria (median difference, 30.0%; P&amp;lt; .001); excluding age criteria, the increase was 11.5% (P&amp;lt; .001). Non-Hispanic (NH) Asian, NH Black, NH White, and Hispanic patients were eligible for median proportions of 41.1%, 44.0%, 47.9%, and 50.0%, respectively, with trial-based criteria, increasing by 27.9% to 31.6% when using safety-based criteria (within-group changes, all P&amp;lt; .001; between-group changes, all P&amp;gt; .05). Excluding age criteria, increases were between 10.0% and 11.9%. Moving from trial- to safety-based criteria decreased the proportion of trials with significant eligibility differences between NH White and NH Asian (\u221211.1%), NH Black (\u22124.2%), and Hispanic (\u221212.1%) patients. Criteria significantly associated with increased eligibility and decreased between-group differences in eligibility were coronary artery disease, congestive heart failure, aspartate transaminase level, upper age limits, and previous malignancy. These data suggest that modernization of eligibility for AML trials to focus on safety-based criteria can improve both overall enrollment and population representation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025030741","type":"journal-article","created":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T19:21:09Z","timestamp":1760642469000},"page":"639-649","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":5,"title":["Impact of modernizing eligibility criteria on enrollment and representation in acute myeloid leukemia clinical trials"],"prefix":"10.1182","volume":"147","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9612-3643","authenticated-orcid":false,"given":"Andrew","family":"Hantel","sequence":"first","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yating","family":"Wang","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angel","family":"Cronin","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1855-7731","authenticated-orcid":false,"given":"Irum","family":"Khan","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivy","family":"Abraham","sequence":"additional","affiliation":[{"name":"4Department of Medicine, The University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann-Kathrin","family":"Eisfeld","sequence":"additional","affiliation":[{"name":"5Department of Internal Medicine, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0296-8686","authenticated-orcid":false,"given":"Anand A.","family":"Patel","sequence":"additional","affiliation":[{"name":"4Department of Medicine, The University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Stock","sequence":"additional","affiliation":[{"name":"4Department of Medicine, The University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Monick","sequence":"additional","affiliation":[{"name":"4Department of Medicine, The University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2620-6843","authenticated-orcid":false,"given":"Thomas P.","family":"Walsh","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Gallagher","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5781-4529","authenticated-orcid":false,"given":"Marlise R.","family":"Luskin","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2918-8401","authenticated-orcid":false,"given":"Ana Maria","family":"Avila Rodriguez","sequence":"additional","affiliation":[{"name":"6Department of Medicine, University of Illinois Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2155-0939","authenticated-orcid":false,"given":"Carlos","family":"Galvez","sequence":"additional","affiliation":[{"name":"6Department of Medicine, University of Illinois Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6242-5395","authenticated-orcid":false,"given":"Peter","family":"Doukas","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica K.","family":"Altman","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madelyn","family":"Burkart","sequence":"additional","affiliation":[{"name":"7Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amani","family":"Erra","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Zia","sequence":"additional","affiliation":[{"name":"8Department of Internal Medicine, Saint Louis University, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa L.","family":"Larson","sequence":"additional","affiliation":[{"name":"9Department of Internal Medicine, Rush University Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ami","family":"Dave","sequence":"additional","affiliation":[{"name":"9Department of Internal Medicine, Rush University Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie B.","family":"Tsai","sequence":"additional","affiliation":[{"name":"10Department of Medicine, Loyola University Chicago, Maywood, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Aleen","sequence":"additional","affiliation":[{"name":"10Department of Medicine, Loyola University Chicago, Maywood, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nepheli","family":"Raptis","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Northwestern University, Chicago, IL"},{"name":"10Department of Medicine, Loyola University Chicago, Maywood, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher S.","family":"Lathan","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0622-8471","authenticated-orcid":false,"given":"Hajime","family":"Uno","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"DeAngelo","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory A.","family":"Abel","sequence":"additional","affiliation":[{"name":"1Dana-Farber Cancer Institute, Boston, MA"},{"name":"2Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","reference":[{"key":"2026020908413205300_bib1","volume-title":"Cancer Clinical Trial Eligibility Criteria: Laboratory Values","year":"2024"},{"key":"2026020908413205300_bib2","doi-asserted-by":"crossref","first-page":"106515","DOI":"10.1016\/j.cct.2021.106515","article-title":"Eligibility criteria and clinical trials: an FDA perspective","volume":"109","author":"Duggal","year":"2021","journal-title":"Contemp Clin Trials"},{"issue":"20","key":"2026020908413205300_bib3","doi-asserted-by":"crossref","first-page":"2193","DOI":"10.1200\/JCO.21.02492","article-title":"Eligibility criteria perpetuate disparities in enrollment and participation of Black patients in pancreatic cancer clinical trials","volume":"40","author":"Riner","year":"2022","journal-title":"J Clin Oncol"},{"issue":"3","key":"2026020908413205300_bib4","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1093\/jnci\/djaa155","article-title":"\"When Offered to Participate\": a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials","volume":"113","author":"Unger","year":"2021","journal-title":"J Natl Cancer Inst"},{"issue":"7","key":"2026020908413205300_bib5","doi-asserted-by":"crossref","first-page":"1178","DOI":"10.1093\/jnci\/djae067","article-title":"Racial and ethnic associations with comprehensive cancer center access and clinical trial enrollment for acute leukemia","volume":"116","author":"Hantel","year":"2024","journal-title":"J Natl Cancer Inst"},{"issue":"32","key":"2026020908413205300_bib6","doi-asserted-by":"crossref","first-page":"3709","DOI":"10.1200\/JCO.22.00307","article-title":"Inequities in Alliance Acute Leukemia Clinical Trial and Biobank participation: defining targets for intervention","volume":"40","author":"Hantel","year":"2022","journal-title":"J Clin Oncol"},{"issue":"6","key":"2026020908413205300_bib7","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1016\/j.clml.2023.03.012","article-title":"FDA analysis of ineligibility for acute myeloid leukemia clinical trials by race and ethnicity","volume":"23","author":"Pulte","year":"2023","journal-title":"Clin Lymphoma Myeloma Leuk"},{"issue":"13","key":"2026020908413205300_bib8","doi-asserted-by":"crossref","first-page":"1369","DOI":"10.1182\/blood.2023023717","article-title":"Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement","volume":"145","author":"Borate","year":"2025","journal-title":"Blood"},{"issue":"9","key":"2026020908413205300_bib9","doi-asserted-by":"crossref","first-page":"2745","DOI":"10.1182\/bloodadvances.2021006504","article-title":"Improving eligibility criteria for first-line trials for patients with DLBCL using a US-based Delphi-method survey","volume":"6","author":"Harkins","year":"2022","journal-title":"Blood Adv"},{"issue":"16","key":"2026020908413205300_bib10","doi-asserted-by":"crossref","first-page":"4414","DOI":"10.1182\/bloodadvances.2024012838","article-title":"Evaluating the impact of laboratory-based eligibility criteria by race\/ethnicity in first-line clinical trials of DLBCL","volume":"8","author":"Khurana","year":"2024","journal-title":"Blood Adv"},{"issue":"4","key":"2026020908413205300_bib11","doi-asserted-by":"crossref","first-page":"EVIDoa2300236","DOI":"10.1056\/EVIDoa2300236","article-title":"Broadening eligibility criteria and diversity among patients for cancer clinical trials","volume":"3","author":"Kaur","year":"2024","journal-title":"NEJM Evid"},{"key":"2026020908413205300_bib12","volume-title":"Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings","year":"2022"},{"issue":"33","key":"2026020908413205300_bib13","doi-asserted-by":"crossref","first-page":"3737","DOI":"10.1200\/JCO.2017.73.7916","article-title":"Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research statement","volume":"35","author":"Kim","year":"2017","journal-title":"J Clin Oncol"},{"issue":"4","key":"2026020908413205300_bib14","first-page":"1046","article-title":"Use, variability, and justification of eligibility criteria for phase II and III clinical trials in acute leukemia","volume":"109","author":"Hantel","year":"2024","journal-title":"Haematologica"},{"issue":"14","key":"2026020908413205300_bib15","doi-asserted-by":"crossref","first-page":"2212","DOI":"10.1182\/blood.2021012830","article-title":"Structural racism is a mediator of disparities in acute myeloid leukemia outcomes","volume":"139","author":"Abraham","year":"2022","journal-title":"Blood"},{"key":"2026020908413205300_bib16","unstructured":"Fludarabine phosphate injection, for intravenous use. United States Food and Drug Administration. Accessed 21 October 2025. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/022137s015lbl.pdf."},{"issue":"3","key":"2026020908413205300_bib17","first-page":"1","article-title":"mice: multivariate imputation by chained equations in R","volume":"45","author":"van Buuren","year":"2011","journal-title":"J Stat Softw"},{"key":"2026020908413205300_bib18","first-page":"202","volume-title":"Multiple Imputation for Nonresponse in Surveys","author":"Rubin","year":"2004"},{"key":"2026020908413205300_bib19","unstructured":"Heymans\n              MW\n            , EekhoutI. Applied Missing Data Analysis With SPSS and (R) Studio. Bookdown. Accessed 24 May 2024. https:\/\/bookdown.org\/mwheymans\/bookmi\/."},{"issue":"2","key":"2026020908413205300_bib20","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1001\/jamaoncol.2022.5985","article-title":"Use of single-arm trials for US Food and Drug Administration drug approval in oncology, 2002-2021","volume":"9","author":"Agrawal","year":"2023","journal-title":"JAMA Oncol"},{"issue":"17","key":"2026020908413205300_bib21","doi-asserted-by":"crossref","first-page":"1471","DOI":"10.1001\/jama.2024.2396","article-title":"Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval","volume":"331","author":"Liu","year":"2024","journal-title":"JAMA"},{"issue":"2","key":"2026020908413205300_bib22","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1038\/s41591-024-03352-5","article-title":"Evaluating generalizability of oncology trial results to real-world patients using machine learning-based trial emulations","volume":"31","author":"Orcutt","year":"2025","journal-title":"Nat Med"},{"issue":"24","key":"2026020908413205300_bib23","doi-asserted-by":"crossref","first-page":"2105","DOI":"10.1001\/jama.2024.6281","article-title":"Survival benefit associated with participation in clinical trials of anticancer drugs","volume":"331","author":"Iskander","year":"2024","journal-title":"Jama"},{"issue":"11","key":"2026020908413205300_bib24","doi-asserted-by":"crossref","first-page":"2434","DOI":"10.1038\/s41588-024-01929-x","article-title":"Multiomic profiling identifies predictors of survival in African American patients with acute myeloid leukemia","volume":"56","author":"Stiff","year":"2024","journal-title":"Nat Genet"},{"issue":"3","key":"2026020908413205300_bib25","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1158\/2159-8290.CD-20-1579","article-title":"Poor survival and differential impact of genetic features of Black patients with acute myeloid leukemia","volume":"11","author":"Bhatnagar","year":"2021","journal-title":"Cancer Discov"},{"issue":"21","key":"2026020908413205300_bib26","doi-asserted-by":"crossref","first-page":"1969","DOI":"10.1056\/NEJMp2409329","article-title":"The Duffy null phenotype - addressing a source of discrimination in cancer care","volume":"391","author":"Hantel","year":"2024","journal-title":"N Engl J Med"},{"issue":"9","key":"2026020908413205300_bib27","doi-asserted-by":"crossref","first-page":"e2432475","DOI":"10.1001\/jamanetworkopen.2024.32475","article-title":"Cancer trial eligibility and therapy modifications for individuals with Duffy null-associated neutrophil count","volume":"7","author":"Hibbs","year":"2024","journal-title":"JAMA Netw Open"},{"issue":"11","key":"2026020908413205300_bib28","doi-asserted-by":"crossref","first-page":"1437","DOI":"10.1093\/jnci\/djac152","article-title":"Implementing modernized eligibility criteria in US National Cancer Institute clinical trials","volume":"114","author":"Denicoff","year":"2022","journal-title":"J Natl Cancer Inst"},{"issue":"16 suppl","key":"2026020908413205300_bib29","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1200\/JCO.2024.42.16_suppl.1589","article-title":"Identifying eligibility criteria that perpetuate race\/ethnic disparities in acute myeloid leukemia (AML) clinical trial participation [abstract]","volume":"47","author":"Hantel","year":"2024","journal-title":"J Clin Oncol"}],"container-title":["Blood"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/147\/6\/639\/2501567\/blood_bld-2025-030741-main.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/147\/6\/639\/2501567\/blood_bld-2025-030741-main.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T13:41:42Z","timestamp":1770644502000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/blood\/article\/147\/6\/639\/547827\/Impact-of-modernizing-eligibility-criteria-on"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,5]]},"references-count":29,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,2,5]]}},"URL":"https:\/\/doi.org\/10.1182\/blood.2025030741","relation":{"is-basis-for":[{"id-type":"doi","id":"10.52843\/cassyni.c5s7md","asserted-by":"object"}]},"ISSN":["0006-4971","1528-0020"],"issn-type":[{"value":"0006-4971","type":"print"},{"value":"1528-0020","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,2,5]]},"published":{"date-parts":[[2026,2,5]]}}}