Potentially modifiable eligibility criteria lead to inequalities in participation in AML clinical trials

Eligibility criteria for clinical trials in acute myeloid leukemia (AML) have been found to exclude individuals from minority populations to varying degrees, and some of the criteria causing these differences were modifiable or removable, according to data from a multicenter cohort study conducted at the ASCO Annual Meeting 2024.

Andrew Hantel, MD, and colleagues evaluated data from 1283 real-world patients with newly diagnosed AML, including patients from the non-Hispanic white population (n = 878) and patients from minority populations (n ​​= 405). The results showed that patients from minority populations were eligible for 6.8% fewer trials compared to the non-Hispanic white population (P P = .04), prolonged QTc (20.5%; 12.8%; P P = .001) resulted in the largest differences between populations.

“We have seen that there are a variety of criteria that lead to [disparities in trial enrollment]which leads to these differences of 5 to 15% [between non-Hispanic White and minority populations]”, explained Hantel.

In an interview with OncLive^®Hantel elaborated on the goal of evaluating clinical trial eligibility criteria and their role in disparities in AML trials, discussed the importance of re-evaluating eligibility criteria for future clinical trials, and highlighted the implications of this real-world study.

Hantel is an instructor of medicine at Harvard Medical School and a faculty member in the Divisions of Leukemia and Population Sciences at the Dana-Farber Cancer Institute and the HMS Center for Bioethics in Boston, Massachusetts.

OncLive: What was the rationale for evaluating eligibility criteria that contribute to racial and ethnic disparities in AML clinical trials?

dumbbell: Some of our previous work examined whether there are differences between the admission criteria that [have been] used in clinical trials in leukemia and the criteria that might have been introduced if those criteria had been based only on the drug safety signals known to us at the time the trial was initiated.

We previously identified that there was a major gap. The criteria for trials were much more restrictive than they needed to be based on the drug safety data known at the time. Therefore, there was a gap [for us to ask]: Are these overly restrictive criteria leading to inequalities in participation in clinical trials?

What methods did you use in your study?

We took a group of [patients] from the Dana-Farber Cancer Institute and 6 other hospitals across the country [greater] Chicago area with newly diagnosed leukemia. We have this [previous trial enrollment] criteria that we knew and applied them to this population to ask: If these were all newly diagnosed patients coming to us, what would have happened to them? Would they have been eligible or would they have been deemed ineligible? [for a trial] based on any of the criteria?

What key findings did your study reveal?

In this case, when we took these common criteria, [from prior clinical trials] and applied it to [the study’s] population, we found differences by race and ethnicity, both in more intensive sets of criteria used for younger adults and in less intensive sets of criteria used in some studies for older adults. In both cases, we found that non-Hispanic white populations were 5 to 20 percent more likely to be eligible for a study compared with minority groups. [The difference] varies by which [minority] Group we talked about, but [the differences were observed] among Hispanics, non-Hispanic Asians and non-Hispanic blacks [populations].

We also looked at which [eligibility] Criteria seemed to make the biggest difference [in terms of causing these disparities]. They varied a little depending on the group. Overall, there were laboratory values ​​such as QTC [interval]This is one of the things we have to check before someone is brought to court, as well as before [medical] Diseases such as hepatitis B.

What are the implications of the results of this study?

The FDA recently issued some guidelines to minimize approval criteria when they are not required. [Findings from our study] are proof that there are differences due to [these eligibility criteria]If we succeed in rationally liberalising the criteria, [without] Patients [at risk] for any excessive damage and [still] involve as many people as possible [from different] To include as many parts of the population in the studies as we can. [This will help better establish] the safety and efficacy of these drugs in the [real-world] populations in which they will ultimately be used.

reference

Hantel A, Wang Y, Abraham I, et al. Identification of eligibility criteria that maintain racial/ethnic disparities in participation in acute myeloid leukemia (AML) clinical trials. J Clin Oncology. 2024;42(Suppl 16):1589. doi:10.1200/JCO.2024.42.16_suppl.1589