Trial · NCT07911540
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Incidence of temperature elevation indicative of Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Incidence of high-grade (grade 2 or higher) Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants who experience grade 2 or higher CRS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Time to resolution of Cytokine Release Syndrome (CRS) from temper elevation indicative of CRS (temperature ≥ 100.4 °F) | From the temperature elevation (≥ 100.4 °F) to resolution during the 14 days after CAR-T infusion. | 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. |
| Secondary | Time to intervention after fever detection (temperature ≥ 100.4 °F) | From the temperature elevation (≥ 100.4 °F) to intervention during the 14 days after CAR-T infusion. | 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. |
| Secondary | Incidence of admission to the Intensive Care Unit (ICU) due to temperature elevation indicative of CRS | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Time to discharge after admission to the Intensive Care Unit (ICU) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Length of hospital stay | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants experiencing ICANS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Largest change in body temperature from baseline recorded during the 14-day post-CAR-T observation period | From the initiation of CAR-T infusion up to Day 14 post-infusion. | The maximum numerical difference in body temperature recorded from baseline during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | The proportion of hours during the 14-day post CAR-T observation period when patch was worn | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | 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 | From the initiation of CAR-T infusion up to Day 14 post-infusion. | 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. |
| Secondary | Patient satisfaction with CAR-T temperature monitoring methods | The Day 14 post-infusion (+28 days) study calendar visit. | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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