Monitoring complications during immunotherapy for blood cancers
Official title: Early Detection of Complications During Immunotherapy for Haematological Malignancy - Description of Associated Vital Signs and Immune Responses
Run by Copenhagen University Hospital, Rigshospitalet · NCT06377059 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | CART, chimeric antigen receptor, chemotherapy, immunotherapy |
| Locations | 1 site (Copenhagen O) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06377059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are pregnant, have a pacemaker, or are allergic to the monitoring equipment materials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Rigshospitalet
Copenhagen O, Denmark Recruiting
Study contacts
- Principal investigator: Sandra Egedie Lyby Taylor Pitter, MD — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Sandra Egedie Lyby Taylor Pitter, MD
- Email: sandra.egedie.taylor.pitter@regionh.dk
- Phone: +4540309153
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.