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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04107285
Status
Recruiting
Apply to this trial

Conditions

  • Lymphoma Receiving CAR-T Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

Start date
Sep 25, 2019
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Neurocognitive evaluation prior to and following CART

Primary Outcome Measure

changes in neurocognitive functions [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Bianca Santomasso, MD, PhD
646-888-2092
Dennis Correa, PhD
212-610-0487
Bianca Santomasso, MD (PRINCIPAL_INVESTIGATOR)

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