Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome, Neurotoxicity, Neurotoxicity Syndromes
Conditions
Keywords
Neurotoxicity, Neurotoxicity Syndrome, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDCog Short
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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of DCog Short for Early Detection of Neurotoxicity | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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%. |
| Specificity of DCog Short for Early Detection of Neurotoxicity | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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%. |
| Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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. |
| Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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. Negative predictive value is defined as the proportion of patients not indicated by DCog Short who do not develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment. |
| Raw Accuracy of DCog Short for Early Detection of Neurotoxicity | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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. Raw accuracy is defined as the proportion of patients correctly classified by DCog Short, including both patients who develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and those who do not, based on standard clinical assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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. |
| Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. | 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. |
Countries
United States
Contacts
CONTACTJon Arnason, MD
PRINCIPAL_INVESTIGATORJon Arnason, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed