Non Hodgkin LymphomaNCT05416554
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 study testing Neuropsychological testing in people with Non Hodgkin Lymphoma, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- Neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Center
San Francisco, California, 94305
About this study
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
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
- Being tested
- Neuropsychological testing
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological testing | Other | Participants will take neuropsychological testing in-person or via telehealth video Receives: Behavioral: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who complete neuropsychological testing in the post-CAR-T adult population
Measured: 6 months
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Short form of Quality of Life SF-36
Items from the SF36 (Short Form 36) survey
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Scott, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416554
- Sponsor's protocol ID
- IRB-56813
- Other IDs
- CCT5069
- Status last verified
- May 2026
- First submitted
- 20 May 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05416554
- Acronym / sponsor ID
- IRB-56813
- Conditions
- Non Hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological testing | Other | Behavioral: Neuropsychological testingParticipants will take neuropsychological testing in-person or via telehealth video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >/= 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingUpon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing | Behavioural | Neuropsychological testing |
Primary outcome
Number of patients who complete neuropsychological testing in the post-CAR-T adult population
Time frame: 6 months
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
Time frame: 6 months
9 secondary outcomes
Wechsler Test of Adult Reading WTAR Neuropsychological testing
Time frame: Baseline
Hopkins Verbal Learning Test HVLT
Time frame: Baseline
Controlled Oral Work Association Test COWAT
Time frame: Baseline
Trails A and B (Oral Trails)
Time frame: Baseline
Digit Span
Time frame: Baseline
Clock Drawing Test
Time frame: Baseline
Short form of Quality of Life SF-36
Time frame: Baseline
General Anxiety Disorder Assessment GAD-7
Time frame: Baseline
Patient Health Questionnaire PHQ9
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Scott, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing in people with Non Hodgkin Lymphoma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who complete neuropsychological testing in the post-CAR-T adult population (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.