VitalTraq for the Detection of CRS

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415656
• Other study ID #: Pro00115012
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Lauren Hill
• Phone: 7045774113
• Email: lauren9494[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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
• 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

Exclusion Criteria:

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

2. Receiving Epcoritamab

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Device:
• TempTraq
TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
• VitalTraq
VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Blue Spark Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TempTraq's ability to measure axillary temperature in the intended use population.	Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers.	Day 14
Secondary	Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.	The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature > 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers.	Day 14
Secondary	VitalTraq's ability to measure blood pressure in the intended use population.	Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively.	Day 14
Secondary	VitalTraq's ability to measure heart rate in the intended use population.	Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute.	Day 14
Secondary	Patient's perspective on the burden of using TempTraq and VitalTraq.	The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden.	Day 28
Secondary	Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care.	The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring.	Day 14