Clinical trial NCT04107285: Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
Official title: A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma Receiving CAR-T Therapy
Keywords: Neurocognitive Evaluations
Neuroimaging Evaluations
19-268
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.

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.


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)

Primary outcomes:
measure: changes in neurocognitive functions
timeFrame: 1 year
measure: changes in functional connectivity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Bianca Santomasso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: