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

Neurotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144151
• Other study ID #: 2023-0176
• Secondary ID: NCI-2023-09804
• Status: Recruiting
• Start date: February 8, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Ranjit Nair, MD
• Phone: (713) 563-4354
• Email: rnair[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.

Secondary Objective:

To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings

Exploratory Objective:

To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Device:
• NeurOptics® NPi®-300 Pupillometer
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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   MD Anderson Cancer Center Website