Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)
Not Applicable
Recruiting
- Conditions
- CAR-TCytokine Release Syndrome
- Interventions
- Device: Cytosorb
- Registration Number
- NCT04048434
- Lead Sponsor
- Hannover Medical School
- Brief Summary
Patients with severe CAR-T cell associated cytokine release syndrome (CRS) (defined as vasopressor dependent) will be treated with standard of care (SOC) + cytokine adsorption (6hourly for 24 hrs).
Primary endpoint is the change in plasma IL-6 between 0 and 24 hrs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- severe CRS (> 3) and / or severe CRES (>3)
AND
- CRS/CRES onset < 6 hrs
Exclusion Criteria
- Heparine allergy
- contraindication for anticoagulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyotosorb Cytosorb -
- Primary Outcome Measures
Name Time Method IL-6 change 24 hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Cytosorb's cytokine adsorption in CAR-T associated CRS and CRES?
How does extracorporeal cytokine adsorption with Cytosorb compare to tocilizumab in managing severe CAR-T CRS?
Which biomarkers correlate with IL-6 reduction and clinical outcomes in NCT04048434 Cytosorb trials?
What are the potential adverse events of Cytosorb therapy in vasopressor-dependent CAR-T patients?
How does Cytosorb's cytokine removal profile compare to other devices like Hemopure for CRS management?
Trial Locations
- Locations (2)
Hannover Medical School
🇩🇪Hannover, Germany
Universitätsspital Zürich (USZ)
🇨🇭Zürich, Switzerland