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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurocognitive evaluation prior to and following CART |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurocognitive evaluations | Behavioral | The test battery consists of validated and reliable measures of attention, executive functions and memory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| changes in functional connectivity | MRIs | 1 year |
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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
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:
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Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bianca Santomasso, MD, PhD | Contact | 646-888-2092 | santomab@mskcc.org | |
| Denise Correa, PhD | Contact | 212-610-0487 |
| Name | Affiliation | Role |
|---|---|---|
| Bianca Santomasso, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |