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

Not Applicable

Not yet recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Behavioral: Neuropsychological testing

• Registration Number: NCT05416554
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Study Start: 2024-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuropsychological testing	Neuropsychological testing	Participants will take neuropsychological testing in-person or via telehealth video

Primary Outcome Measures

Name	Time	Method
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult	6 months
Number of patients who complete neuropsychological testing in the post-CAR-T adult population	6 months

Secondary Outcome Measures

Name	Time	Method
Trails A and B (Oral Trails)	Baseline	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.
Wechsler Test of Adult Reading WTAR Neuropsychological testing	Baseline	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.
Patient Health Questionnaire PHQ9	Baseline	Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27
Hopkins Verbal Learning Test HVLT	Baseline	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.
Controlled Oral Work Association Test COWAT	Baseline	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.
Digit Span	Baseline	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.
Clock Drawing Test	Baseline	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.
Short form of Quality of Life SF-36	Baseline	Items from the SF36 (Short Form 36) survey
General Anxiety Disorder Assessment GAD-7	Baseline	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

Trial Locations

Locations (1)

Stanford Cancer Center; 🇺🇸 San Francisco, California, United States