Status:
RECRUITING
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Neurotoxicity
Eligibility:
All Genders
18+ years
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.
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 im...
Eligibility Criteria
Inclusion
- To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion 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
- 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
Key Trial Info
Start Date :
February 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06144151
Start Date
February 8 2024
End Date
April 1 2027
Last Update
October 24 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030