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

Recruiting

Interventions: Behavioral: neurocognitive evaluations
Diagnostic Test: brain MRIs
Other: Blood samples

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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)

Arm && Interventions

Group	Intervention	Description
Neurocognitive evaluation prior to and following CART	neurocognitive evaluations	-
Neurocognitive evaluation prior to and following CART	brain MRIs	-
Neurocognitive evaluation prior to and following CART	Blood samples	-

Primary Outcome Measures

Name	Time	Method
changes in neurocognitive functions	1 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 connectivity	1 year	MRIs

Secondary Outcome Measures

Name	Time	Method

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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