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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Lymphoma Receiving CAR-T Therapy

Treatments: Other: Blood samples; Diagnostic Test: brain MRIs; Behavioral: neurocognitive evaluations

Study type: Observational

Funder types: Other

Identifiers

NCT04107285

19-268

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 1 patient group

Neurocognitive evaluation prior to and following CART

Treatment:

Behavioral: neurocognitive evaluations

Diagnostic Test: brain MRIs

Other: Blood samples