VitalTraq for the Detection of CRS

Launched by DUKE UNIVERSITY · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two devices that help monitor important health signs in patients with blood cancers who are receiving specific types of treatments called CAR-T therapy or BiTE products. The first device, TempTraq, is a small patch that sticks to the skin and keeps track of body temperature all the time. The second device, VitalTraq, uses a smartphone app to take a quick picture of the face to check vital signs like blood pressure, heart rate, and breathing. The goal is to see if these monitoring tools can help detect problems related to the treatment, such as cytokine release syndrome (CRS), earlier so that doctors can provide help sooner.

To participate in the trial, you must be an adult over 18 years old with a blood cancer and be receiving one of the approved treatments. You also need to have a smartphone that works with the VitalTraq app and be able to understand and read English. Throughout the study, participants will use these devices to help track their health, and the information gathered may lead to better care for patients in the future. If you’re interested, it’s important to discuss this opportunity with your doctor to see if you qualify.

Gender

ALL

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