Rationale
Patients receiving intensive therapies for hematological malignancies, such as chimeric antigen receptor (CAR) T-cell therapy or autologous hematopoietic stem cell transplantation (HSCT), frequently experience adverse effects caused by high-dose chemotherapy, immunosuppressive agents, steroids, or total parenteral nutrition. These interventions can trigger a hyperinflammatory response through the release of cytokines and chemokines, leading to complications such as infections, cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS).

Despite this risk, most patients do not develop serious complications. For instance, up to 70% of patients post-autologous HSCT remain free of infections, and most CAR T-cell recipients do not experience grade ≥3 CRS, ICANS, or severe infections. Nonetheless, all patients are currently monitored in inpatient settings, leading to increased hospital occupancy, elevated costs, patient stress, and potential exposure to nosocomial infections.

Outpatient administration of CAR T-cell therapy and HSCT has shown promise in enhancing patient autonomy and cost efficiency, reducing expenses by up to 40%. However, early and sensitive detection of deterioration remains essential for the safe implementation of this model. Continuous wearable monitoring may enable real-time detection of adverse events and inform timely readmissions only when clinically necessary.

Study Objectives
To develop and validate a technology-driven, real-time prediction model for treatment-related adverse events using continuous physiological monitoring with the Corsano CardioWatch 287-2. The model will incorporate wearable-derived vital signs along with clinical parameters to predict adverse events as defined by CTCAE v5.0.
• Primary Outcome: Sensitivity of the model to detect treatment-related adverse events.
• Secondary Outcomes: Comparison of wearable-derived vital signs with conventional nurse-obtained measurements; Cost-effectiveness analysis of implementing continuous monitoring in this setting.

Study Design
This is a single-centre, prospective observational study conducted at the University Medical Center Groningen (UMCG). A total of 250 consecutive adult patients hospitalized for CAR T-cell therapy or autologous HSCT will be enrolled.
Patients will wear the Corsano CardioWatch 287-2 throughout their hospital stay. This CE-MDR and FDA-approved wearable device measures vital signs continuously, including: pulse rate, heart rate variability, oxygen saturation, respiration rate, cuffless non-invasive blood pressure, core body temperature. Routine care includes four-times-daily vital sign assessments by hospital staff. Data collected by the CardioWatch will be blinded from both patients and clinicians and will not influence treatment decisions. An interim analysis will be performed after the inclusion of 125 patients to assess measurement accuracy. If performance criteria are not met, the study may be terminated prematurely.

Inclusion Criteria
• Adults ≥18 years
• Dutch-speaking and writing
• Hospitalized for CAR T-cell therapy or autologous HSCT

Exclusion Criteria
• Inability to provide informed consent
• Inability to wear the CardioWatch 287-2 (due to allergic reactions, wounds, or amputation)
• Severe cognitive or mental impairment (as determined by the treating physician)

Current Status
The study is currently ongoing. As of now, 72 patients have been enrolled across the following subgroups:
• 40 patients receiving allogeneic stem cell transplantation
• 15 patients receiving autologous stem cell transplantation
• 15 patients undergoing CAR T-cell therapy
• 5 patients receiving intensive chemotherapy

Timeline
Status: recruiting patients
Start Date: January 2026
Estimated Study Duration: 2.5 years

Study center
University Medical Center Groningen (UMCG), The Netherlands