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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04048434
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
CytoSorbents, Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cytokine Release Syndrome CAR-T Device: Cytosorb Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
No Intervention: Standard of care (SOC)
Experimental: Cyotosorb Device: Cytosorb
extracorporeal cytokine adsorption

Primary Outcome Measures :
  1. IL-6 change [ Time Frame: 24 hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • severe CRS (> 3) and / or severe CRES (>3)


- CRS/CRES onset < 6 hrs

Exclusion Criteria:

  • Heparine allergy
  • contraindication for anticoagulation

Information from the National Library of Medicine

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 identifier (NCT number): NCT04048434

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Contact: Sascha David, MD +495115329357
Contact: Klaus Stahl, MD +495115327623

Sponsors and Collaborators
Hannover Medical School
CytoSorbents, Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hannover Medical School Identifier: NCT04048434    
Other Study ID Numbers: CRS01
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pathologic Processes