Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS) (CYTORELEASE)
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|ClinicalTrials.gov Identifier: NCT04048434|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cytokine Release Syndrome CAR-T||Device: Cytosorb||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
|No Intervention: Standard of care (SOC)|
extracorporeal cytokine adsorption
- IL-6 change [ Time Frame: 24 hrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048434
|Contact: Sascha David, MDfirstname.lastname@example.org|
|Contact: Klaus Stahl, MDemail@example.com|