Non Hodgkin Lymphoma
Conditions
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.
Interventions
BEHAVIORALNeuropsychological testing
Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Wechsler Test of Adult Reading WTAR Neuropsychological testing | 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. |
| Hopkins Verbal Learning Test HVLT | 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. |
| Controlled Oral Work Association Test COWAT | 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. |
| Trails A and B (Oral Trails) | 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. |
| Digit Span | 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. |
| Clock Drawing Test | 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. |
| Short form of Quality of Life SF-36 | Baseline | Items from the SF36 (Short Form 36) survey |
| General Anxiety Disorder Assessment GAD-7 | 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 |
| Patient Health Questionnaire PHQ9 | Baseline | Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian Scott, MD
Stanford University
Outcome results
None listed