Back to resultsLong-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford
Primary Purpose
Non Hodgkin Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuropsychological testing
Sponsored by
About this trial
This is an interventional supportive care trial for Non Hodgkin Lymphoma
Eligibility 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
Sites / Locations
- Stanford Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Neuropsychological testing
Arm Description
Participants will take neuropsychological testing in-person or via telehealth video
Outcomes
Primary Outcome Measures
Number of patients who complete neuropsychological testing in the post-CAR-T adult population
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Short form of Quality of Life SF-36
Items from the SF36 (Short Form 36) survey
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416554
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuropsychological testing
Arm Type
Other
Arm Description
Participants will take neuropsychological testing in-person or via telehealth video
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing
Primary Outcome Measure Information:
Title
Number of patients who complete neuropsychological testing in the post-CAR-T adult population
Time Frame
6 months
Title
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wechsler Test of Adult Reading WTAR Neuropsychological testing
Description
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.
Time Frame
Baseline
Title
Hopkins Verbal Learning Test HVLT
Description
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.
Time Frame
Baseline
Title
Controlled Oral Work Association Test COWAT
Description
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.
Time Frame
Baseline
Title
Trails A and B (Oral Trails)
Description
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.
Time Frame
Baseline
Title
Digit Span
Description
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.
Time Frame
Baseline
Title
Clock Drawing Test
Description
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.
Time Frame
Baseline
Title
Short form of Quality of Life SF-36
Description
Items from the SF36 (Short Form 36) survey
Time Frame
Baseline
Title
General Anxiety Disorder Assessment GAD-7
Description
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
Time Frame
Baseline
Title
Patient Health Questionnaire PHQ9
Description
Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian J Scott, MD
Phone
(650) 723-6409
Email
bjscott@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Scott, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian J Scott, MD
Phone
bjscott@stanford.edu
Email
bjscott@stanford.edu
First Name & Middle Initial & Last Name & Degree
Michelle Monje, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gayle Deutsch, PhD, ABPP
First Name & Middle Initial & Last Name & Degree
Matthew J Frank, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sheila Lahijani, MD
First Name & Middle Initial & Last Name & Degree
Tracy P Murray, MSN, RN, AGACNP-BC
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs