Recruiting NCT04107285
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neurocognitive evaluations, brain MRIs, Blood samples.
- Who it may be relevant to
- Registry conditions: Lymphoma Receiving CAR-T Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
Overview
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
- Behavioral neurocognitive evaluations
The test battery consists of validated and reliable measures of attention, executive functions and memory. - Diagnostic test brain 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). - Other Blood 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.
Primary outcome measures
- changes in neurocognitive functions [Time frame: 1 year]
- changes in functional connectivity [Time frame: 1 year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT04107285 · 19-268