VitalTraq for the Detection of CRS

Description

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Conditions

Hematologic Malignancy

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy

VitalTraq for the Detection of CRS

Condition
Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Blood Cancer Center, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:
  • * Axicabtagene ciloleucel
  • * Lisocabtagene maraleucel
  • * Brexucabtagene autoleucel
  • * Idecabtagene vicleucel
  • * Ciltacabtagene autoleucel
  • * Obecabtagene autoleucel
  • * Tisagenlecleucel
  • * Blinatumomab
  • * Mosunetuzumab
  • * Talquetamab
  • * Elranatamab
  • * Teclistamab
  • * Glofitamab
  • 2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.
  • 3. Able to read and understand English
  • 4. Willing and able to provide informed consent to the study
  • 1. Receiving a non-FDA approved CAR-T or BiTE product
  • 2. Receiving Epcoritamab

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Chenyu Lin, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2025-12-31