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

Pilot Study of Neurocognitive and Neuroimaging Evaluations for Adult Patients Receiving CD19 CART Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma Receiving CAR-T Therapy
• Intervention / Treatment: Behavioral: neurocognitive evaluations; Diagnostic test: brain MRIs; Other: Blood samples

• Study Type: Observational
• Enrollment (Estimated): 21

Contacts and Locations

• Study Contact: Name: Denise Correa, PhD; Phone Number: 212-610-0487
• Study Contact Backup: Name: Bianca Santomasso, MD, PhD; Phone Number: 646-888-2092; Email: santomab@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Bianca Santomasso, MD, PhD; Phone Number: 646-888-2092
      • Contact: Dennis Correa, PhD; Phone Number: 212-610-0487
      • Principal Investigator: Bianca Santomasso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving commercially approved CD19 CART cells will be identified in the Cellular Therapeutics Center (CTC) clinic, Adult Bone marrow transplant (BMT) and lymphoma service at MSK.

Description

Inclusion Criteria:

• ≥ 18 years old
• Pathologically confirmed, relapsed refractory large B-cell lymphoma including DLBCL (de novo disease or transformed follicular lymphoma), DLBCL NOS, high grade B-cell lymphoma, and primary mediastinum B-cell lymphoma
• Planned treatment with commercially approved CD19-specific CART cells (e.g. axicabtagene ciloleucel or tisagenlecleucel).
• Eastern Cooperative Group (ECOG) performance status of 0 to 2
• No evidence of central nervous system disease at study entry
• Meet cardiac, pulmonary, hepatic, and renal requirement for CART therapy as described in corresponding product package insert
• 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. °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:

• Signs and/or symptoms of central nervous system cancers (e.g., tumors, 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Neurocognitive evaluation prior to and following CART

Behavioral: neurocognitive evaluations; The test battery consists of validated and reliable measures of attention, executive functions and memory.; Diagnostic test: brain MRIs; 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).; Other: Blood samples; Blood samples will be collected at each time point (Day -1, day 0, day 1, day 3, day 5, day 7, day 10, day of neurotoxicity onset, and 3-4 months post- CART).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Bianca Santomasso, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Neurocognitive Evaluations; Neuroimaging Evaluations; 19-268
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 19-268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No