RecruitingNCT04107285

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

A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

120 participants

Start Date

Sep 25, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a type of immunotherapy called CAR-T cell therapy affects the brain and thinking abilities in people with lymphoma. Researchers want to understand any cognitive (thinking and memory) changes that may happen before, during, or after treatment. **You may be eligible if...** - You are 18 years old or older - You are scheduled to receive a CAR-T cell therapy (such as axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexucabtagene autoleucel) for lymphoma - You are able to communicate well in English **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have been diagnosed with a major psychiatric condition such as schizophrenia or bipolar disorder - You have a history of a degenerative brain disease or a significant head injury with prolonged loss of consciousness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALneurocognitive evaluations

The test battery consists of validated and reliable measures of attention, executive functions and memory.

DIAGNOSTIC_TESTbrain MRIs

Patients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes).

OTHERBlood samples

Research blood samples will be collected pre-CAR T infusion; day of CART infusion (day 0), and post-infusion days 7, 14, 21, 28 (+/- 7 days), at start of neurotoxicity, and at 3-4 months and 6-7 months post-CART.


Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT04107285


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