Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- TempTraq's ability to measure axillary temperature in the intended use population.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Receiving a non-FDA approved CAR-T or BiTE product
- •Receiving Epcoritamab
研究组 & 干预措施
Patients with hematologic malignancies
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
干预措施: TempTraq (Device)
Patients with hematologic malignancies
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
干预措施: VitalTraq (Device)
结局指标
主要结局
TempTraq's ability to measure axillary temperature in the intended use population.
时间窗: 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.
TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population
时间窗: 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).
次要结局
- 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)
- VitalTraq's ability to measure heart rate in the intended use population.(Day 14)
- Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.(Day 14)
- VitalTraq's ability to measure blood pressure in the intended use population.(Day 14)
- Patient's perspective on the burden of using TempTraq and VitalTraq.(Day 28)
- Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements(Day 14)
- VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population.(Day 14)
- VitalTraq's Ability to Measure Heart Rate in the Intended Use Population.(Day 14)
- Patient's Perspective on the Burden of Using TempTraq and VitalTraq(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.(Day 14)