Monitoring complications during immunotherapy for blood cancers
Early Detection of Complications During Immunotherapy for Haematological Malignancy - Description of Associated Vital Signs and Immune Responses
This study is testing a new way to keep an eye on patients with blood cancers during immunotherapy to catch problems early and improve their safety and care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | CART, chimeric antigen receptor, chemotherapy, immunotherapy |
| Locations | 1 site (Copenhagen O) |
| Trial ID | NCT06377059 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance patient safety during immunotherapy for hematologic malignancies by developing a risk model that combines physiological and immunological parameters. It focuses on continuous wireless monitoring of vital signs to detect complications early, potentially preventing up to 40% of adverse events. The research integrates three projects, including a system for real-time surveillance of respiratory and circulatory distress, to improve patient outcomes and care levels. By identifying high-risk patients who require closer observation, the study seeks to optimize treatment protocols and enhance overall patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hematologic malignancies who are scheduled for treatment with CAR T-cell therapy or bispecific antibodies.
Not a fit: Patients who are pregnant, have a pacemaker, or are allergic to the monitoring equipment materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of complications in patients undergoing immunotherapy for blood cancers.
How similar studies have performed: While the approach of using wireless monitoring for patient safety is promising, this specific combination of physiological and immunological monitoring in hematologic cancer treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients diagnosed with haematologic malignant disease (e.g. malignant lymphoma) * Patients scheduled for treatment with CART or BsAbs Exclusion Criteria: * 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
Where this trial is running
Copenhagen O
- Rigshospitalet — Copenhagen O, Denmark (Recruiting)
Study contacts
- Principal investigator: Sandra Egedie Lyby Taylor Pitter, MD — Rigshospitalet, Denmark
- Study coordinator: Sandra Egedie Lyby Taylor Pitter, MD
- Email: sandra.egedie.taylor.pitter@regionh.dk
- Phone: +4540309153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.