Neurotoxicity Clinical Trial
Official title:
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.
Primary Objective: To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion. Secondary Objective: To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings Exploratory Objective: To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy. ;
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