A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting

Browse trials for

• Neoplasms, Plasma Cell 2,312
• Cytokine Release Syndrome 139

Keywords

• Cytokine release syndrome
• CAR-T infusion
• TempShield patch

Neoplasms, Plasma Cell

2,312 studies on the registry are indexed under Neoplasms, Plasma Cell; 246 are open to participants now.

This study's planned enrollment of 105 is above the median of 39 across 1,826 interventional studies indexed under Neoplasms, Plasma Cell.

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,350 studies on the registry; 203 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 250 (76%) have results posted.

Study arms

• Other
  Arm A: TempShield Continuous Temperature Monitoring plus SOC Temperature Monitoring

  Standard of care oral temperature monitoring plus TempShield continuous temperature monitoring patch

  Other: TempShield Continuous Temperature Monitoring

• Other
  Arm B: SOC Temperature Monitoring

  Standard of care oral temperature monitoring

  Other: Standard of Care

• No intervention
  Arm C: Provider/Staff

  Providers/staff are Hospital at Home personnel who support patients undergoing outpatient CAR-T therapy and who have monitored at least one participant enrolled on Arm A of the study.

Interventions

• OtherTempShield Continuous Temperature Monitoring

  Patient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee.

• OtherStandard of Care

  Standard of care oral temperature monitoring

Primary outcomes

1. Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS)

   Time (in hours) from the initiation of CAR-T infusion to the first occurrence of a recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Participants who do not experience this defined temperature elevation within the 14 days will be censored at the time of their last recorded temperature reading during this window. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

Secondary outcomes

1. Incidence of temperature elevation indicative of Cytokine Release Syndrome (CRS)

   Number of participants who experience at least one recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

2. Incidence of high-grade (grade 2 or higher) Cytokine Release Syndrome (CRS)

   Number of participants who experience grade 2 or higher CRS during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

3. Time to resolution of Cytokine Release Syndrome (CRS) from temper elevation indicative of CRS (temperature ≥ 100.4 °F)

   Time (in hours) from the from onset of fever indicative of CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period to resolution (i.e., when the participant no longer meets the CRS diagnostic criteria). If a participant experiences multiple episodes of CRS during the 14-day post-CAR-T observation period, the duration can be calculated per episode and cumulatively. This will be calculated for participants experiencing CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the temperature elevation (≥ 100.4 °F) to resolution during the 14 days after CAR-T infusion.

4. Time to intervention after fever detection (temperature ≥ 100.4 °F)

   Time (in hours) from documented temperature elevation of ≥ 100.4° F to clinician intervention (e.g., supportive care, medication followed by observation, etc.). This will be calculated for participants experiencing CRS during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the temperature elevation (≥ 100.4 °F) to intervention during the 14 days after CAR-T infusion.

5. Incidence of admission to the Intensive Care Unit (ICU) due to temperature elevation indicative of CRS

   Number of participants admitted to the ICU due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

6. Time to discharge after admission to the Intensive Care Unit (ICU)

   Time (in hours) from ICU admission to ICU discharge. If a participant has multiple ICU admissions during the 14-day post-CAR-T observation period, the duration will be calculated cumulatively. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

7. Length of hospital stay

   Number of inpatient nights from hospital admission to hospital discharge due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. If a participant has multiple hospital admissions due to CRS during the 14-day post-CAR-T observation period, the duration reported will be cumulative across all stays. This endpoint will be calculated for participants admitted to this hospital during the 14-day post-CAR-T observation period due to temperature elevation indicative of CRS. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

8. Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

   Number of participants experiencing ICANS during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

9. Largest change in body temperature from baseline recorded during the 14-day post-CAR-T observation period

   The maximum numerical difference in body temperature recorded from baseline during the 14-day post-CAR-T observation period. Reported by arm.

   Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

10. The proportion of hours during the 14-day post CAR-T observation period when patch was worn

    The proportion of hours during the 14-day post-CAR-T observation period in which at least one valid human body temperature reading (86 °F to 108 °F) was recorded by the wearable patch, defined as Total adherence = (Number of hours with at least one valid temperature reading)/(24\*14 hours). This will be calculated for participants randomized to wear the remote temperature monitoring device.

    Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

11. The proportion of paired temperature readings from the temperature patch and an oral thermometer within one degree Fahrenheit in a five-minute window during the 14-day post-CAR-T observation period

    The number 5-minute intervals in the 14-day post-CAR-T observation period (from the first patch reading indicating a temperature from 86 °F to 108 °F), when concordance between the temperature patch and an oral thermometer within one degree Fahrenheit was observed.

    Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.

12. Patient satisfaction with CAR-T temperature monitoring methods

    Patient satisfaction as assessed by the study survey, evaluating satisfaction on a Likert scale where higher scores indicate a higher level of patient satisfaction with the assigned monitoring method (standard of care vs. wearable patch).

    Time frame: The Day 14 post-infusion (+28 days) study calendar visit.