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Recruiting
NCT06144151
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Conditions: Neurotoxicity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
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
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
Source: ClinicalTrials.gov (NCT06144151). StuddyBuddy aggregates publicly available trial information.