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Cognitive and Brain Changes in Lymphoma Patients Receiving CAR-T Therapy

This study is looking at how CAR-T cell therapies (like axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexucabtagene autoleucel) might affect your thinking abilities (cognition), such as memory and concentration, and your brain's structure and function. Researchers will use neurocognitive evaluations (tests of your mental abilities) and brain MRIs (magnetic resonance imaging) to see these changes. They will also collect blood samples to understand more about the CAR-T treatment. The goal is to see how these mental abilities and brain connections change over one year. This study is for adults aged 18 or older with lymphoma who are planning to receive one of these CAR-T therapies and have good organ function. We are looking to enroll 120 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving new treatments. It aims to enroll 120 participants.
What's involved
You would undergo neurocognitive evaluations and brain MRIs. Blood samples will be collected at several points before and after your CAR-T infusion.
Compensation
Not stated in the trial record.
Follow-up
Your neurocognitive functions and brain connectivity will be measured for changes at 1 year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04107285

Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~120 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:neurocognitive evaluationsbrain MRIsBlood samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
changes in neurocognitive functions
Measured over 1 year
+1 more outcome measured

Conditions

Lymphoma Receiving CAR-T Therapy

Explore related trials

LymphomaCD19 Gene

NCT04107285

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bianca Santomasso, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Bianca Santomasso, MD, PhD
[email protected]
646-888-2092
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patients must be 18 years of age or older
Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
Patients must have adequate end organ function for CAR T cell therapy
Eastern Cooperative Group (ECOG) performance status of 0 to 2
Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
No evidence of central nervous system disease at study entry
Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required

Exclusion

Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report
A history of epilepsy as per medical records or patient report
Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)

What this trial measures

  • changes in neurocognitive functions1 year

    correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue \[66\]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52).

  • changes in functional connectivity1 year

    MRIs