A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NeurOptics® NPi®-300 Pupillometer.
- Who it may be relevant to
- Registry conditions: Neurotoxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Device NeurOptics® NPi®-300 Pupillometer
The pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes.
Primary outcome measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
Inclusion criteria
To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.
Inclusion criteria
- Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
- Sexes Eligible for Study: All
- 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
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients who have already been administered CAR-T cell therapy.
- The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
- Patient has a condition which places him at an unacceptable risk as determined by the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06144151 · 2023-0176 · NCI-2023-09804