VitalTraq for the Detection of CRS

Last updated: April 18, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Cancer

Hematologic Neoplasms

Treatment

VitalTraq

TempTraq

Clinical Study ID

NCT06415656
Pro00115012
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults at or over the age of 18 with hematologic malignancies undergoing treatmentwith 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

  1. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with theVitalTraq app and that can connect to wi-fi. This will be assessed at screening.

  2. Able to read and understand English

  3. Willing and able to provide informed consent to the study

Exclusion

Exclusion Criteria:

  1. Receiving a non-FDA approved CAR-T or BiTE product

  2. Receiving Epcoritamab

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: VitalTraq
Phase:
Study Start date:
October 13, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Duke Blood Cancer Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

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