RecruitingNot ApplicableNCT06377059

Early Detection of Complications During Immunotherapy for Haematological Malignancy

Early Detection of Complications During Immunotherapy for Haematological Malignancy - Description of Associated Vital Signs and Immune Responses

Sponsor

Rigshospitalet, Denmark

Enrollment

100 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Hematologic Cancer CRS - Cytokine Release Syndrome

Summary

Aims * To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications * Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age ≥ 18 years
Patients diagnosed with haematologic malignant disease (e.g. malignant lymphoma)
Patients scheduled for treatment with CART or BsAbs

Exclusion Criteria4

Patient is pregnant
Patient has a pacemaker
Patient is allergic to one or more of the materials that the equipment consists of
Investigator deems patient not able to comply with participation in the study

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Interventions

DEVICEWARD

Heart rate and respiratory rate is measured using Isansys lifetouch (Isansys Lifecare, Oxfordshire, UK), single-lead ECG monitor. An ECG is recorded as a 10-second segment every minute. Heart rate is derived once per minute from the R-R interval, and similarly, the RF is calculated from the changes in thoracic impedance once per minute. Blood pressure is monitored with either Meditech BlueBP-05 (Meditech Ltd., Budapest, Hungary) or A\&D TM-2441 (A\&D company Ltd., Tokyo, Japan). Both are non-invasive oscillometric, cuff-based blood pressure monitoring devices. Peripheral oxygen saturation was measured with NonIn WristOx 3150 (Nonin Medical Inc., Minnesota, USA) pulse oximeter, which is a photoplethysmograph with a sampling frequency of 75 Hz.