Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
Sponsor: National Cancer Institute (NCI)
Trial Details
| Condition | Cytokine Release Syndrome, Neoplasms, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Multiple Myeloma, Lymphoma Mantle-cell, Immunotherapy, Cell and Tissue-Based Therapy, Cytokines, Monitoring Physiologic, Immune Monitoring, Wearable Electronic Devices, Thermometry, Body Temperature, Antibodies Bispecific, Receptors Chimeric Antigen |
| Intervention | TempTraq; VitalTraq |
| Phase | NA |
| Status | Unknown |
| Participants | 136 |
| Est. Completion | 30 June 2029 |
| Last Updated | 25 June 2026 |
Primary Outcome
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 Criteria
Inclusion Criteria
* 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. EXCLUSION CRITERIA: * 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.
Trial Sites
Countries
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