Assessing DCog Short for Neurotoxicity in CAR-T

N/ANot Yet RecruitingNCT07403812

Beth Israel Deaconess Medical Center40 enrolled

Overview

The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.

The goal of this pilot study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy. This is the first time investigators are examining this tool. The U.S. Food and Drug Administration (FDA) has not approved DCOG Short as a mobile application tool to evaluate neurotoxicity for hematologic malignancies. The research study procedures include screening for eligibility, questionnaires, and cognitive assessments. It is expected that about 40 people will take part in this research study.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neurotoxicity Neurotoxicity Syndromes Hematologic Malignancy Immune Effector Cell Associated Neurotoxicity Syndrome

Interventions

DCog ShortBEHAVIORAL

An iPad-based cognitive assessment instrument to evaluate neurotoxicity and consisting of a series of tests that measure various aspects of cognitive function. After hospital discharge, participants will be provided with iPads which will be returned at the 90 day follow up visit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity. * Visual acuity of 20/100 or better. Exclusion Criteria: * patients \< 18 years old * pregnant women * prisoners * adults unable to consent, * participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Sensitivity of DCog Short for Early Detection of Neurotoxicity

Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to detect neurotoxicity on or before the onset of clinically confirmed ICANS. Sensitivity is defined as the proportion of patients with clinically confirmed ICANS for whom DCog Short indicates neurotoxicity on or before ICANS onset. DCog Short will be considered effective if sensitivity is ≥75% and non-promising if sensitivity is \<50%.

Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Specificity of DCog Short for Early Detection of Neurotoxicity

Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Specificity is defined as the proportion of patients who do not develop clinically confirmed ICANS and are not indicated by DCog Short. DCog Short will be considered effective if specificity is ≥75% and non-promising if specificity is \<50%.

Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity

Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Positive predictive value is defined as the proportion of patients indicated by DCog Short who subsequently develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.

Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Central Contacts

Jon Arnason, MD

CONTACT

(617) 667-9920 jarnason@bidmc.harvard.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline

For ICANS detection and monitoring, the Immune Effector Cell-Associated Encephalopathy (ICE) score, also called CARTOX-10, will be used. The total score ranges from 0 to 10, with higher scores indicating normal cognitive function. Detailed scoring instructions and grading criteria are provided in Appendix A of the protocol.

Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types

Neurotoxicity will be monitored using DCog Short and CARTOX-10 assessments throughout the study period. Immune Effector Cell-Associated Encephalopathy (ICE) score, e ranges from 0 to 10, with higher scores indicating normal cognitive function. Detailed scoring instructions and grading criteria are provided in Appendix A of the protocol.

Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.