Examining cognitive and brain changes in lymphoma patients receiving CAR-T therapy
A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
This study is testing how CAR-T therapy for lymphoma affects memory, concentration, and brain health in patients receiving this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | CAR T, CART, CAR-T |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04107285 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate potential changes in cognitive abilities, such as memory and concentration, as well as alterations in brain structure and function among individuals with lymphoma undergoing CAR-T therapy. Participants will undergo neurocognitive evaluations, brain MRIs, and blood sample collection to assess these changes. The study focuses on patients who are receiving specific CAR-T cell treatments for lymphoma and will evaluate their mental and neurological health throughout the therapy process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to receive CAR-T therapy for lymphoma and meet specific health criteria.
Not a fit: Patients with central nervous system disease or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive effects related to CAR-T therapy, potentially leading to better patient management and support strategies.
How similar studies have performed: While there is ongoing research into cognitive effects of cancer therapies, this specific focus on CAR-T therapy and its neurocognitive impacts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Bianca Santomasso, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Bianca Santomasso, MD, PhD
- Email: santomab@mskcc.org
- Phone: 646-888-2092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.