Status:
RECRUITING
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lymphoma Receiving CAR-T Therapy
Eligibility:
All Genders
18+ years
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 lym...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04107285
Start Date
September 25 2019
End Date
September 1 2026
Last Update
October 24 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065