Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford

Study Overview
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Brief Summary
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This study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following Axicabtagene ciloleucel CAR-T therapy at Stanford.

Official Title
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Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford - A Pilot Study

Conditions
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Non Hodgkin Lymphoma

Intervention / Treatment
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* Behavioral: Neuropsychological testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18 years-old Treated with Axicabtagene ciloleucel CAR-T therapy at Stanford Or Treated with standard commercial Axicabtagene ciloleucel CAR-T therapy elsewhere and followed primarily by SHC Blood and Bone Marrow transplant providers >/= 6 months from the date of CAR-T infusion Fluent in English Able to attend and participate in in-person testing (Arm I) Able to participate in remote video testing with adequate workspace, computer and internet capabilities for a reliable telehealth video connection (Arm II) Exclusion Criteria: Concurrent enrollment in a CAR-T therapeutics research study Unable to be present for the scheduled testing Unable to participate in testing due to severe cognitive or physical limitation Actively receiving chemotherapy Progressive cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neuropsychological testing<br>Participants will take neuropsychological testing in-person or via telehealth video | Behavioral: Neuropsychological testing<br>* Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who complete neuropsychological testing in the post-CAR-T adult population |  | 6 months | 
| Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Test of Adult Reading WTAR Neuropsychological testing | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Hopkins Verbal Learning Test HVLT | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Controlled Oral Work Association Test COWAT | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Trails A and B (Oral Trails) | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Digit Span | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Clock Drawing Test | The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data. | Baseline | 
| Short form of Quality of Life SF-36 | Items from the SF36 (Short Form 36) survey | Baseline | 
| General Anxiety Disorder Assessment GAD-7 | Assesses anxiety symptoms The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety, Score greater than 15: Severe Anxiety | Baseline | 
| Patient Health Questionnaire PHQ9 | Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27 | Baseline |