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

NCT05416554 | Withdrawn

• 2 other identifiers: IRB-56813CCT5069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Wechsler Test of Adult Reading WTAR Neuropsychological testing

  Baseline

• Hopkins Verbal Learning Test HVLT

  Baseline

• Controlled Oral Work Association Test COWAT

  Baseline

• Trails A and B (Oral Trails)

  Baseline

• Digit Span

  Baseline

Study Arms (1)

Neuropsychological testing

OTHER

Participants will take neuropsychological testing in-person or via telehealth video

Behavioral: Neuropsychological testing

Interventions

Neuropsychological testing BEHAVIORAL

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

Neuropsychological testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Center

San Francisco, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Brian Scott, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 13, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-05

Locations

US (1)