VitalTraq for the Detection of CRS

Duke University

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Device: VitalTraq; Device: TempTraq

Study type: Interventional

Funder types: Other

Identifiers

NCT06415656

Pro00115012

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Patients with hematologic malignancies

Experimental group

Description:

Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

Treatment:

Device: TempTraq

Device: VitalTraq