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

Memorial Sloan Kettering Cancer Center1 site in 1 country120 target enrollmentSeptember 25, 2019

ConditionsLymphoma Receiving CAR-T Therapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lymphoma Receiving CAR-T Therapy
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 120
Locations: 1
Primary Endpoint: changes in neurocognitive functions
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 25, 2019

End Date

September 1, 2026

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

changes in neurocognitive functions

Time Frame: 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

Time Frame: 1 year

MRIs