Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS)
研究概览
简要总结
Background:
Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of getting serious CRS.
Objective:
To learn if an approved patch called TempTraq can detect fever before serious CRS develops.
Eligibility:
People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies.
Design:
Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet.
Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan.
Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell.
Blood may be drawn for research.
Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.
详细描述
Background:
- Cellular therapy and cellular engager-based immunotherapy treatments, including but not limited to Chimeric Antigen Receptor (CAR) T-cell and bispecific T-cell engagers (BiTE), have an adverse event profile that often involves Grade >= 3 Cytokine Release Syndrome (CRS).
- As a sequela of activating the immune system to engage their underlying cancer, CRS symptoms can range from grade 1 (e.g., fever amenable to supportive care with antipyretics) to grade 4 (e.g., multiorgan failure requiring hospital admission for advanced vasopressor and ventilator support), even proceeding to death in severe cases.
- The symptoms of CRS can escalate over time, but early detection with accelerated intervention has been shown to avert high-grade CRS and more serious complications.
- A prompt CRS diagnosis shortens the treatment window for targeted interventions. Such as tocilizumab, a monoclonal antibody that blocks the interleukin (IL)-6 receptor, or systemic corticosteroids. Agents that can mitigate CRS from progressing to more severe grades, decrease the need for Intensive Care Unit (ICU) management, and could potentially redefine CRS monitoring using an outpatient management algorithm.
- TempTraq is a Food and Drug Administration (FDA)-cleared continuous temperature monitoring (CTM) wearable patch device. Compared with intermittent temperature monitoring used in Standard of Care (SOC) practice, this CTM approach has been shown to detect fevers earlier by a median of 4.9 hours.
- VitalTraq is a multi-vital, multi-sensor smartphone/Tablet application allowing data collection of blood pressure, heart rate, heart rate variability, and respiration rate using Remote Photoplethysmography technology (rPPG). The VitalTraq application involves a viscerocranial capillary scan, whereby a camera scans the small blood vessels of the face for 30-60 seconds. VitalTraq has not yet been FDA-cleared.
Objective:
-To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS)
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Age >= 18 years.
- •Participants must be enrolled in an active treatment protocol at NIH utilizing cellular therapy, cellular engagers, or other novel monotherapy or combination immunotherapy agents associated with a known or anticipated risk profile for grade >= 3 cytokine release syndrome (CRS) adverse effects.
- •Participants must be receiving immunotherapy dose(s) and be admitted to the Clinical Center. Note: Enrollment during the first week of treatment on an active treatment protocol, when CRS risk is highest, is preferable, but starting later during their active treatment course is acceptable.
- •Ability of the participant to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior solid organ or stem cell transplantation on active immunosuppression.
- •Regimen including antibiotics, for documented active infection within 7 days prior to study enrollment.
- •Current syndrome associated with cyclic fevers.
- •History of severe drug allergies, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
- •Known current alcohol use disorder or drug use disorder that, in the opinion of the investigator, would interfere with the participant s ability to comply with study procedures or safely participate in the study.
研究组 & 干预措施
Control Arm 2
Use of non-readable CTM devices, TempTraq without actionable alerts, and optional use of black-boxed VitalTraq
Intervention Arm 1
Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq
干预措施: TempTraq (Device)
Intervention Arm 1
Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq
干预措施: VitalTraq (Device)
结局指标
主要结局
To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS)
时间窗: TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment
Posterior means of the CRS severe adverse event per arm will be reported, along with the corresponding 95% credible intervals in the highest density interval (HDI) based on the corresponding posterior distributions
次要结局
- To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduce the duration of CRS episodes(TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment)
- To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduces the escalation of CRS care(TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment)