Expanding access and enrollment to precision medicine trials in Acute Myeloid Leukemia

Outcomes for Acute Myeloid Leukemia (AML) remain poor, with 30% 5-year overall survival, and most AML patients are not treated on clinical trials. The objective of this R50 Clinician Scientist Award application is to address two critical barriers to enrolling patients to precision medicine trials in AML: 1) the limited availability of rapid molecular testing; and 2) community and patient education regarding the importance of clinical trials in AML. The NCI MyeloMATCH studies feature rapid centralized molecular testing and clinical trial assignment. Not all patients are candidates for these studies and not all trials offer this option, and there remains a need for rapid in-house molecular testing for all patients with AML. Furthermore, outcomes for African American and Hispanic patients with AML are worse than white patients. Differences in disease biology contribute to the outcomes disparity for African American patients, spotlighting the need for prospective study in clinical trials. Minority patients are profoundly under-represented in trials of new drugs approved in AML, with no trial enrolling more than 10% African American and Hispanic participants combined. There is an urgent need to expand access to precision medicine trials in AML to all patients, and especially to under-represented minority patients, as we develop innovative, targeted treatments. The FDA has approved 11 new drugs in AML since 2017. However, it remains unclear how to use these drugs in combination or sequence, and there is little randomized data for these newer agents against each other. The NCI cooperative groups are the only US clinical research mechanism with the ability to answer these critical research questions and potentially transform AML treatment. Single-arm, single-institution studies are hypothesis-generating, but MyeloMATCH is critical due to its unique ability to bring investigators together to design trials and put strategies to the test in larger patient populations at more sites. If we do not aggressively enroll to these studies, we will miss the window of opportunity to better understand how these newer agents work in specific AML subsets, how they perform compared to each other, and how resistance develops. I will lead a focused effort to address barriers to access and enrollment for precision medicine trials in AML which includes: leveraging the NCI MyeloMATCH program; developing dynamic, in-house rapid molecular testing for AML patients; and expanding University of Kansas Cancer Center (KUCC) clinical trials outreach efforts to underserved patients across our catchment area. Salary support and protected time through the R50 mechanism will allow me to expand leukemia and clinical research efforts across the catchment area, developing strategies which can serve as a model for other disease teams at KUCC. My roles as Director of the Acute Leukemia Program, Medical Director of the KUCC Clinical Trials Office (CTO), SWOG representative to the NCI MyeloMATCH Younger Adult AML Working Group and on the KUCC Health Equity Committee give me the necessary skills to successfully lead these efforts. Project Number: 1R50CA293244-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Tara Lin | Institution: UNIVERSITY OF KANSAS MEDICAL CENTER, KANSAS CITY, KS | Award Amount: $135,949 | Activity Code: R50 | Study Section: Special Emphasis Panel[ZCA1 SRB-5 (M1)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11224932