About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Trial design
Cohort
Prospective
Treatments tested in this trial
neurocognitive evaluations
BehavioralThe test battery consists of validated and reliable measures of attention, executive functions and memory.
brain MRIs
Diagnostic testPatients 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).
Blood samples
Other interventionResearch 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
changes in functional connectivity
MRIs
Sponsors and contacts
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