DCog Short for Neurotoxicity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new iPad app, DCog Short, to determine its effectiveness in assessing neurotoxicity (nerve damage) in individuals receiving CAR-T cell therapy, a cancer treatment. The goal is to quickly identify and treat patients experiencing nerve-related side effects. Participants will use the app daily during their hospital stay and continue through follow-up phone calls. Individuals who have undergone CAR-T cell therapy and have decent vision are encouraged to join. As an unphased trial, this study allows participants to contribute to innovative research that could enhance patient care.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this application tool is safe for assessing neurotoxicity?
Research has shown that CAR T-cell therapy, which the DCog Short app assesses, can cause side effects. Studies have found that patients often experience neurotoxicity, affecting the brain and nervous system, with common symptoms like confusion and memory problems.
The DCog Short app is a tool for monitoring these side effects. No evidence suggests that using the app is unsafe, as it is not a drug or treatment but a means to track side effects.
For those considering joining the study, it's important to know that the app helps understand and manage the side effects of CAR T-cell therapy. While the therapy carries known risks, the app aims to better track and manage those risks.12345Why are researchers excited about this trial?
Unlike traditional treatments for neurotoxicity, such as supportive care and corticosteroids, the DCog Short protocol is designed to proactively monitor and manage cognitive changes in patients undergoing CAR-T cell therapy. The unique approach involves frequent assessments during hospitalization and consistent follow-ups via phone, allowing for timely intervention. Researchers are excited about this trial because it aims to catch and address neurotoxic effects early, potentially improving patient outcomes and quality of life.
What evidence suggests that the DCog Short application is effective for assessing neurotoxicity?
A previous study explored DCog Short as a tool to check for harmful effects on the nervous system in patients receiving CAR-T cell therapy. In the current trial, researchers designed it to detect changes in brain function by collecting self-reported data through an iPad app. Although direct proof of its effectiveness is not yet available, DCog Short aims to spot these harmful effects during treatment. This tool seeks to simplify patient monitoring and catch potential issues early. Initial findings suggest that technology like DCog Short could offer a promising and convenient way to track these changes.678910
Who Is on the Research Team?
Jon Arnason, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with visual acuity of 20/100 or better who are undergoing CAR-T cell therapy, which is a treatment for certain blood cancers. Participants should be at risk for neurotoxicity due to their treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete baseline assessments before CAR-T cell therapy
Treatment
Participants undergo CAR-T cell therapy and daily neurotoxicity assessments using DCog Short during hospitalization
Post-Treatment Monitoring
Participants continue neurotoxicity assessments via phone weekly on days 21-30
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 90-day follow-up visit
What Are the Treatments Tested in This Trial?
Interventions
- DCog Short
Trial Overview
The study tests DCog Short, an iPad-based app designed to self-report and assess neurotoxicity symptoms in patients receiving CAR-T cell therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
40 enrolled participants will complete: * Baseline visit * Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30 * 90 Day follow up visit
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Citations
Assessing DCog Short for Neurotoxicity in CAR-T
The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity ...
DCog Short for Neurotoxicity · Info for Participants
The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity ...
Current status and future directions for a neurotoxicity ...
Neurotoxicology is the study of adverse effects on the structure or function of the developing or mature adult nervous system following exposure to chemical ...
NB2013-HR German (GPOH) / Dutch (DCOG) Trial
This immune therapy resulted in an increase of 20 % Event free survival (EFS) at 2 year from randomization. However, this was associated with a high toxicity ...
Score for Predicting Poor Neurocognitive Outcomes in ...
This prognostic study developed and externally validated a prediction model including 5 risk factors associated with poor neurocognitive outcome at 1 month.
CAR T-cell-associated neurotoxicity in central nervous system ...
The purpose of this review was to summarize currently available neurological safety data of CAR T-cell-based immunotherapy from the clinical trials and real- ...
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ashpublications.org
ashpublications.org/blood/article/137/23/3306/475336/Utility-of-a-safety-switch-to-abrogate-CD19-CAR-TUtility of a safety switch to abrogate CD19.CAR T-cell ...
Clinical and biological correlates of neurotoxicity associated with CAR T-cell therapy in patients with B-cell acute lymphoblastic leukemia.
Study Details | NCT05237986 | Cognitive Aftereffects of ...
CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells.
Patient-reported outcomes and neurotoxicity markers in ...
Elevated levels of kynurenine pathway metabolites among CAR T cell recipients are associated with depressed mood and neurotoxicity.
Immunotherapy-related cognitive impairment after CAR T ...
Results. Impaired cognition in mice after tumor-clearing CAR T cell therapy. To determine whether mice treated with CAR T cell therapy exhibit ...
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