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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Hodgkin Lymphoma
• Intervention / Treatment: Behavioral: Neuropsychological testing

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian J Scott, MD; Phone Number: (650) 723-6409; Email: bjscott@stanford.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94305
      • Stanford Cancer Center
      • Contact: Brian J Scott, MD; Phone Number: bjscott@stanford.edu; Email: bjscott@stanford.edu
      • Sub-Investigator: Michelle Monje, MD, PhD
      • Sub-Investigator: Gayle Deutsch, PhD, ABPP
      • Sub-Investigator: Matthew J Frank, MD, PhD
      • Sub-Investigator: Sheila Lahijani, MD
      • Sub-Investigator: Tracy P Murray, MSN, RN, AGACNP-BC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Brian Scott, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: IRB-56813; CCT5069 (Other Identifier: OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No