A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Purpose
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.
Condition
- Neurotoxicity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the
Exclusion Criteria
. Inclusion Criteria: 1. Ages Eligible for Study: 18 Years and above (Adult, Older Adult) 2. Sexes Eligible for Study: All 3. Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center 4. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have already been administered CAR-T cell therapy. 2. The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer 3. Patient has a condition which places him at an unacceptable risk as determined by the investigator
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
Detailed Description
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.