December 02, 2020
Criteria for inclusion and exclusion in clinical trials of chimeric antigen receptor T-cell (CAR‐T) therapy for hematologic malignancies are highly variable and bring to light the need for a more standardized approach to patient enrollment, according to a study published online in the Journal of Geriatric Oncology.
“Restrictive eligibility criteria are a known barrier to patient enrollment into clinical trials,” researchers wrote. “With the introduction of CAR-T therapy, it is imperative to ensure trials are generalizable to the intended population with appropriate safety guiderails.”
Researchers evaluated enrollment criteria across 84 studies of CAR-T therapy involving adults with hematologic malignancies.
An overwhelming majority had restrictions upper age, performance status, and renal function, the study found. Age restrictions were more common in studies sponsored by institutions compared with industry-sponsored studies.
Neither upper age limit restrictions nor performance status restrictions were linked with a specific study phase.
“Inclusion criteria for renal function,” researchers wrote, “was highly variable and ambiguous; creatinine <1.2–3.0 mg/dL, creatinine clearance >20–60 mL/min, and GFR >30–70 mL/min.”
They concluded with a call for a more evidence-based approach to CAR‐T trial enrollment.
Jaggers JL, Giri S, Klepin HD, et al. Characterizing inclusion and exclusion criteria in clinical trials for chimeric antigen receptor (CAR) T-cell therapy among adults with hematologic malignancies [published online ahead of print, 2020 Aug 24]. J Geriatr Oncol. 2020;S1879-4068(20)30410-0. doi:10.1016/j.jgo.2020.08.004