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

NCT06144151 | Recruiting FDA Device

• 2 other identifiers: 2023-0176NCI-2023-09804
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurotoxicity

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Interventions

NeurOptics® NPi®-300 Pupillometer DEVICE

The pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MD Anderson Cancer Center

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Ranjit Nair, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranjit Nair, MD

CONTACT

(713) 563-4354; rnair@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)