Clinical trial NCT06415656: VitalTraq for the Detection of CRS
Official title: Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Blue Spark Technologies
First posted: 2024-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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

Exclusion Criteria:

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

Primary outcomes:
measure: TempTraq's ability to measure axillary temperature in the intended use population.
timeFrame: Day 14
Secondary outcomes:
measure: Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.
timeFrame: Day 14
measure: VitalTraq's ability to measure blood pressure in the intended use population.
timeFrame: Day 14
measure: VitalTraq's ability to measure heart rate in the intended use population.
timeFrame: Day 14
measure: Patient's perspective on the burden of using TempTraq and VitalTraq.
timeFrame: Day 28
measure: Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care.
timeFrame: Day 14
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Blood Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Chenyu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: