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NCT04048434 Clinical Trial

Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)

Cytokine Release Syndrome Clinical Trial

— CYTORELEASE  

Official title:
Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04048434
Other study ID # CRS01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2021
Est. completion date September 2024

Study information
Verified date March 2021
Source Hannover Medical School
Contact Sascha David, MD
Phone +495115329357
Email david.sascha@mh-hannover.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 34
Est. completion date September 2024
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Cytosorb
extracorporeal cytokine adsorption

Locations
Country Name City State
Germany Hannover Medical School Hannover
Switzerland Universitätsspital Zürich (USZ) Zürich

Sponsors (2)
Lead Sponsor Collaborator
Hannover Medical School CytoSorbents, Inc

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary IL-6 change 24 hours
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