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Not yet recruiting NCT07403812

Assessing DCog Short for Neurotoxicity in CAR-T

No phase Interventional Neurotoxicity Neurotoxicity Syndromes Hematologic Malignancy Immune Effector Cell Associated Neurotoxicity Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DCog Short.
Who it may be relevant to
Registry conditions: Neurotoxicity, Neurotoxicity Syndromes, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study

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.

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

  • Behavioral DCog 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.

Primary outcome measures

  • Sensitivity of DCog Short for Early Detection of Neurotoxicity [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 [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 [Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.]
  • Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity [Time frame: 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 [Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.]
Secondary outcome measures (2)
  • Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline [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 [Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT07403812 · 25-610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗