Assessing pupil changes to predict neurotoxicity after CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.