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

• ClinicalTrials.gov Identifier: NCT05416554
• Recruitment Status: Not yet recruiting
• First Posted: June 13, 2022
• Last Update Posted: November 14, 2022
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non Hodgkin Lymphoma	Behavioral: Neuropsychological testing	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Estimated Study Start Date: February 2023
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of patients who complete neuropsychological testing in the post-CAR-T adult population [ Time Frame: 6 months ]
2. Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Wechsler Test of Adult Reading WTAR Neuropsychological testing [ Time Frame: 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.
2. Hopkins Verbal Learning Test HVLT [ Time Frame: 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.
3. Controlled Oral Work Association Test COWAT [ Time Frame: 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.
4. Trails A and B (Oral Trails) [ Time Frame: 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.
5. Digit Span [ Time Frame: 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.
6. Clock Drawing Test [ Time Frame: 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.
7. Short form of Quality of Life SF-36 [ Time Frame: Baseline ]
   Items from the SF36 (Short Form 36) survey
8. General Anxiety Disorder Assessment GAD-7 [ Time Frame: 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

9. Patient Health Questionnaire PHQ9 [ Time Frame: Baseline ]
   Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Brian J Scott, MD; (650) 723-6409; bjscott@stanford.edu

Locations

United States, California

Stanford Cancer Center

San Francisco, California, United States, 94305

Contact: Brian J Scott, MD bjscott@stanford.edu 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

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Brian Scott, MD; Stanford University

More Information

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT05416554
• Other Study ID Numbers: IRB-56813; CCT5069 ( Other Identifier: OnCore )
• First Posted: June 13, 2022
• Last Update Posted: November 14, 2022
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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