Memorial Sloan Kettering Cancer Center
New York, 10065, United States
Location status: Recruiting
Location contact
Bianca Santomasso, MD
PRINCIPAL_INVESTIGATOR
Bianca Santomasso, MD, PhD
CONTACT
Dennis Correa, PhD
CONTACT
NCT Number: NCT04107285
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
New York, 10065, United States
Location status: Recruiting
Bianca Santomasso, MD
PRINCIPAL_INVESTIGATOR
Bianca Santomasso, MD, PhD
CONTACT
Dennis Correa, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The test battery consists of validated and reliable measures of attention, executive functions and memory.
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).
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.
Time frame: 1 year
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
MRIs
Contact information is provided by the study sponsor or research team.
Bianca Santomasso, MD, PhD
CONTACT
Denise Correa, PhD
CONTACT
Memorial Sloan Kettering Cancer Center
Other
A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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