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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Ranjit Nair, MD
rnair@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Ranjit Nair, MD
(713) 563-4354
rnair@mdanderson.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.