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NCT06144151 | RECRUITING | Neurotoxicity

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

M.D. Anderson Cancer Center

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.

Condition or disease

Neurotoxicity

Intervention/treatment

NeurOptics® NPi®-300 Pupillometer

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Actual Study Start Date : 2024-02-08
Estimated Primary Completion Date : 2027-04-01
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

Location Details

NCT06144151

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Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030