NCT06144151 A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
| NCT ID | NCT06144151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Neurotoxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2027-04-01 |
Trial Parameters
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Brief 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