VitalTraq for the Detection of CRS

Completed · Not applicable

Conditions studied: Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT06415656

Run by

Duke University

People needed

32

Starts

2024-10-13

Expected to finish

2025-07-07

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.
• Able to read and understand English
• Willing and able to provide informed consent to the study

You may not qualify if…

• Receiving a non-FDA approved CAR-T or BiTE product
• Receiving Epcoritamab

Where it is running

• Duke Blood Cancer Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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