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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • neurocognitive evaluations

    Behavioral

    The test battery consists of validated and reliable measures of attention, executive functions and memory.

  • brain MRIs

    Diagnostic test

    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).

  • Blood samples

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Neurocognitive evaluation prior to and following CART3 interventions

Trial outcomes

Primary outcomes

1

changes in neurocognitive functions

correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue \[66\]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52).

Time frame
1 year
2

changes in functional connectivity

MRIs

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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