Assessing pupil changes to predict neurotoxicity after CAR-T therapy
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
M.D. Anderson Cancer Center · NCT06144151
This study is testing if changes in pupil size can help predict neurological side effects in patients receiving CAR-T therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | CAR-T, CAR T |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06144151 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between changes in pupil size and reactivity and the onset of neurological side effects in patients receiving CAR-T cell therapy. The primary objective is to evaluate the association between baseline and post-infusion pupil metrics and the development of neurotoxicity within ten days after treatment. Secondary objectives include assessing the difference in pupil size between eyes and its correlation with clinical symptoms and imaging findings. The study also explores the feasibility and safety of using a pupillometer in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of lymphoma receiving Axi-cel CAR-T cell therapy at MD Anderson Cancer Center.
Not a fit: Patients who have previously received CAR-T therapy or those unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict neurotoxicity in patients undergoing CAR-T therapy, potentially improving patient monitoring and outcomes.
How similar studies have performed: While the approach of using pupillary assessment in this context is novel, similar studies have explored neurotoxicity monitoring in cancer therapies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ranjit Nair, MD — M.D. Anderson Cancer Center
- Study coordinator: Ranjit Nair, MD
- Email: rnair@mdanderson.org
- Phone: (713) 563-4354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurotoxicity