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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T Cell Therapy Patients | Experimental | 40 enrolled participants will complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCog Short | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 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%. | 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. | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon Arnason, MD | Contact | (617) 667-9920 | jarnason@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jon Arnason, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
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| Negative Predictive Value (NPV) 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. 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. | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. |
| Raw Accuracy 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. 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. | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. |
| 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. | Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |