Examining cognitive and brain changes in lymphoma patients receiving CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cohorts A and B

* Patients must be 18 years of age or older
* 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
* Additional Cohort Specific Inclusion Criteria: Cohort A Subjects must meet all of the following criteria to be enrolled in the Lymphoma cohort of this study
* Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
* Additional Cohort Specific Inclusion Criteria: Cohort B Subjects must meet all of the following criteria to be enrolled in the Multiple Myeloma cohort of this study
* Planned treatment with commercial BCMA CAR T cell therapy ciltacabtagene autoleucel for multiple myeloma

Exclusion Criteria:

All Cohorts

* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.