Hematologic MalignancyNCT06415656
VitalTraq for the Detection of CRS
A study testing TempTraq and VitalTraq in people with Hematologic Malignancy, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- TempTraq and VitalTraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2024to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- Obecabtagene autoleucel
- Tisagenlecleucel
- Blinatumomab
- Mosunetuzumab
- Talquetamab
- Elranatamab
- Teclistamab
- Glofitamab
- 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.
- Able to read and understand English
- Willing and able to provide informed consent to the study
Who cannot join
- Receiving a non-FDA approved CAR-T or BiTE product
- Receiving Epcoritamab
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Blood Cancer Center
Durham, North Carolina, 27705
About this study
Official title: Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
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.
- Conditions
- Hematologic Malignancy
- Being tested
- TempTraq, VitalTraq
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TempTraqDevice
TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraqDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematologic malignancies | Experimental | Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program. Receives: Device: TempTraq; Device: VitalTraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
Measured: Day 14
Secondary outcomes (5)
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. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
Measured: Day 14
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. Reported as the difference between the two measurements (TempTraq - SOC).
Measured: Day 14
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. Reported as the difference between the two measurements (TempTraq - SOC).
Measured: Day 14
Patient's Perspective on the Burden of Using TempTraq and VitalTraq
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.
Measured: Day 28
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. Reported as the difference between the two measurements (TempTraq - SOC).
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 Oct 2024
- Primary completion15 Jun 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Spark Technologies
- Responsible party
- Sponsor
- Investigators
- Chenyu Lin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415656
- Sponsor's protocol ID
- Pro00115012
- Status last verified
- Jul 2026
- First submitted
- 7 May 2024
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
- ClinicalTrials.gov ID
- NCT06415656
- Acronym / sponsor ID
- Pro00115012
- Conditions
- Hematologic Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Blue Spark Technologies
- Study start
- 13 Oct 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hematologic malignancies | Experimental | Device: TempTraq, Device: VitalTraqPatients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
- Able to read and understand English
- Willing and able to provide informed consent to the study
Key exclusion criteria (2 listed)
- Receiving a non-FDA approved CAR-T or BiTE product
- Receiving Epcoritamab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TempTraqTempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature. | Device | Patients with hematologic malignancies |
| VitalTraqVitalTraq (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. | Device | Patients with hematologic malignancies |
Primary outcome
TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population
Time frame: 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).
5 secondary outcomes
Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements
Time frame: Day 14
VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population.
Time frame: Day 14
VitalTraq's Ability to Measure Heart Rate in the Intended Use Population.
Time frame: Day 14
Patient's Perspective on the Burden of Using TempTraq and VitalTraq
Time frame: Day 28
Lead Time by Which TempTraq and VitalTraq Can Detect Grade 2 or Higher Cytokine Release Syndrome (CRS) as Compared to the Standard of Care.
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenyu Lin, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TempTraq and VitalTraq in people with Hematologic Malignancy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.