A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

Launched by M.D. ANDERSON CANCER CENTER · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how changes in pupil size and their response to light might help predict neurological side effects in patients who have received CAR-T cell therapy. CAR-T therapy is a type of treatment that uses your own immune cells to fight certain types of cancer, such as lymphoma. By observing how pupils react, researchers hope to find a way to identify patients who may develop neurotoxicity, which can include symptoms like confusion or difficulty speaking.

To be eligible for this study, participants should be adults aged 18 and older who have been diagnosed with specific types of lymphoma and are receiving CAR-T therapy at MD Anderson Cancer Center. Participants will need to provide consent for the study and be willing to have their pupils assessed using a special device. Those who have already received CAR-T therapy or have certain medical conditions may not be able to participate. If you join the study, you can expect to have your pupil reactions monitored throughout your treatment to help improve understanding of potential side effects.

Gender

ALL

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