Early Detection of Complications During Immunotherapy for Haematological Malignancy

NCT06377059 | Recruiting

• 1 other identifier: 2024-RH-phase1-WARD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Cancer; CRS - Cytokine Release Syndrome

Keywords

wireless monitoring

Outcome Measures

Primary Outcomes (1)

• occurrence of cytokine release syndrom

  After treatment, grade 2 or above (see definitions under "study description")

  30 days

Secondary Outcomes (3)

• Immune response

  30 days

• Development of severe physiological deviations

  30 days

• Development of clinical complications

  30 days

Study Arms (1)

WARD equipment alarms

EXPERIMENTAL

alarms will notify the health personel that there is an abnormal vital sign, and the personel will act accordingly.

Device: WARD

Interventions

WARD DEVICE

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.

WARD equipment alarms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen O, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sandra Egedie Lyby Taylor Pitter, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Egedie Lyby Taylor Pitter, MD

CONTACT

+4540309153; sandra.egedie.taylor.pitter@regionh.dk

Eske K Aasvang, Professor

CONTACT

+4535450802; eske.kvanner.aasvang.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 22, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After manuscript publication and up to 5 years
• Access Criteria: Study personell will assess

Locations

DK (1)