Lymphoma Receiving CAR-T Therapy
Conditions
Keywords
Neurocognitive Evaluations, Neuroimaging Evaluations, 19-268
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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in functional connectivity | 1 year | MRIs |
| 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). |
Countries
United States
Contacts
Primary ContactBianca Santomasso, MD, PhD
Backup ContactDenise Correa, PhD
Outcome results
None listed