Hematologic Malignancy
Conditions
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.
Interventions
DEVICETempTraq
TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
DEVICEVitalTraq
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.
Sponsors
Duke University
Blue Spark Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population | Day 14 | Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements | Day 14 | 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. Reported as the difference between the two measurements (TempTraq - SOC thermometers). |
| VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population. | Day 14 | 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. Reported as the difference between the two measurements (TempTraq - SOC). |
| VitalTraq's Ability to Measure Heart Rate in the Intended Use Population. | Day 14 | 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. Reported as the difference between the two measurements (TempTraq - SOC). |
| Patient's Perspective on the Burden of Using TempTraq and VitalTraq | Day 28 | Individual questions in a post-intervention survey feature 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree. The mean score is reported, giving a score range of 1 to 7, where a lower score indicates lower burden. |
| Lead Time by Which TempTraq and VitalTraq Can Detect Grade 2 or Higher Cytokine Release Syndrome (CRS) as Compared to the Standard of Care. | Day 14 | 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. Reported as the difference between the two measurements (TempTraq - SOC). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChenyu Lin, MD
Duke University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed