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ISAL 2025 | Challenges with a new clinical trial design for AML that uses biomarker-driven endpoints
Selina Luger, MD, FRCPC, University of Pennsylvania, Philadelphia, PA, comments on challenges in clinical trial design and participation, specifically focusing on a new clinical trial design for acute myeloid leukemia (AML) that uses biomarker-driven primary endpoints. Prof. Luger emphasizes the importance of understanding the correlation between measurable residual disease (MRD) and event-free and overall survival, as well as ensuring access to a large demographic population. This interview took place at the 19th International Symposium on Acute Leukemias (ISAL XIX) in Munich, Germany.
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Transcript
Well, I think this still brings forward a lot of challenges. We’re trying to choose a biomarker and we’re using MRD by flow at the end of induction, but we need to really understand when that should be tested. We need to know how that correlates with event-free and overall survival. We want to make sure that ultimately that’s the important endpoint. We need to make sure that we are providing access to a large demographic population...
Well, I think this still brings forward a lot of challenges. We’re trying to choose a biomarker and we’re using MRD by flow at the end of induction, but we need to really understand when that should be tested. We need to know how that correlates with event-free and overall survival. We want to make sure that ultimately that’s the important endpoint. We need to make sure that we are providing access to a large demographic population. We also need to make sure that the people who are sending samples in really intend to enroll patients on trials and that we have enough trials available for the patients and that we have enough patients available for the trials. So those are all challenges that are needed. And logistically, really, this has been over five years in the making just to open the first trial. And so we really, it requires a lot of effort and a lot of coordination by a variety of people. So one of the major issues with clinical trial participation is eligibility criteria and making those eligibility criteria quite strict, which makes it difficult for people to fit into the mold. And also the other thing that makes it difficult is if you require a lot of data from the participating sites. And so again, one of the things that we’re really trying to do here is limit both the eligibility criteria and the data collection to what’s really necessary. We need to make sure that we include what’s important, but we also need to make sure that we don’t make the burden heavy on either the patient or the investigator site or the clinical researchers who are doing the work, and that will encourage participation in the trial.
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