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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09804 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.
Inclusion Criteria:
Exclusion Criteria:
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MD Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ranjit Nair, MD | Contact | (713) 563-4354 | rnair@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ranjit Nair, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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