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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Neurocognitive and Neuroimaging Evaluations for Adult Patients Receiving CD19 CART Therapy

Conditions
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Lymphoma Receiving CAR-T Therapy

Intervention / Treatment
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* Behavioral: neurocognitive evaluations
* Diagnostic Test: brain MRIs
* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old Pathologically confirmed, relapsed refractory large B-cell lymphoma including DLBCL (de novo disease or transformed follicular lymphoma), DLBCL NOS, high grade B-cell lymphoma, and primary mediastinum B-cell lymphoma Planned treatment with commercially approved CD19-specific CART cells (e.g. axicabtagene ciloleucel or tisagenlecleucel). Eastern Cooperative Group (ECOG) performance status of 0 to 2 No evidence of central nervous system disease at study entry Meet cardiac, pulmonary, hepatic, and renal requirement for CART therapy as described in corresponding product package insert 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. °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 Criteria: Signs and/or symptoms of central nervous system cancers (e.g., tumors, 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurocognitive evaluation prior to and following CART<br> | Behavioral: neurocognitive evaluations<br>* The test battery consists of validated and reliable measures of attention, executive functions and memory.<br>Diagnostic Test: brain MRIs<br>* 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).<br>Other: Blood samples<br>* Blood samples will be collected at each time point (Day -1, day 0, day 1, day 3, day 5, day 7, day 10, day of neurotoxicity onset, and 3-4 months post- CART).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in neurocognitive functions | 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). | 1 year | 
| changes in functional connectivity | MRIs | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurocognitive Evaluations, Neuroimaging Evaluations, 19-268