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

Non Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416554
• Other study ID #: IRB-56813
• Secondary ID: CCT5069
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Brian J Scott, MD
• Phone: (650) 723-6409
• Email: bjscott[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Non Hodgkin Lymphoma

Intervention

Behavioral:
• Neuropsychological testing
Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing

Locations

Country	Name	City	State
United States	Stanford Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who complete neuropsychological testing in the post-CAR-T adult population		6 months
Primary	Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Short form of Quality of Life SF-36	Items from the SF36 (Short Form 36) survey	Baseline
Secondary	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
Secondary	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