COMPLETED

VitalTraq for the Detection of CRS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-13
Study Completion:2025-07-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06415656

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. * Axicabtagene ciloleucel
  3. * Lisocabtagene maraleucel
  4. * Brexucabtagene autoleucel
  5. * Idecabtagene vicleucel
  6. * Ciltacabtagene autoleucel
  7. * Obecabtagene autoleucel
  8. * Tisagenlecleucel
  9. * Blinatumomab
  10. * Mosunetuzumab
  11. * Talquetamab
  12. * Elranatamab
  13. * Teclistamab
  14. * Glofitamab
  15. 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.
  16. 3. Able to read and understand English
  17. 4. Willing and able to provide informed consent to the study
  1. 1. Receiving a non-FDA approved CAR-T or BiTE product
  2. 2. Receiving Epcoritamab

Contacts and Locations

Principal Investigator

Chenyu Lin, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Chenyu Lin, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-13
Study Completion Date2025-07-07

Study Record Updates

Study Start Date2024-10-13
Study Completion Date2025-07-07

Terms related to this study

Additional Relevant MeSH Terms

  • Hematologic Malignancy