A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
ConditionNeurotoxicity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial population
MD Anderson Cancer Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NeurOptics® NPi®-300 Pupillometer
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov