Early Detection of Complications During Immunotherapy for Haematological Malignancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patients diagnosed with haematologic malignant disease (e.g. malignant lymphoma)
Patients scheduled for treatment with CART or BsAbs
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
WARD
DeviceHeart 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: WARD equipment alarmsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
occurrence of cytokine release syndrom
After treatment, grade 1 or above (see definitions under "study description")
Time frame
30 daysSecondary outcomes
1
Immune response
characterized by TruCulture before anti-cancer treatment and circulating proteomics and biomarkers
Time frame
30 days2
Development of severe physiological deviations
recorded with WARD equipment (e.g. hypotension, desaturation, tachycardia, etc.) post anti-cancer treatment
Time frame
30 days3
Development of clinical complications
(e.g. infection)
Time frame
30 daysLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
RigshospitaletRecruiting2100, Copenhagen O
Denmark
DenmarkSponsors and contacts
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Source ClinicalTrials.gov