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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.
 
ClinicalTrials.gov Identifier: NCT04048434
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
Hannover Medical School

Study Description
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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

Study Design
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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 : June 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of care (SOC)
Experimental: Cyotosorb Device: Cytosorb
extracorporeal cytokine adsorption


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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

Inclusion Criteria:

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

AND

- CRS/CRES onset < 6 hrs

Exclusion Criteria:

  • Heparine allergy
  • contraindication for anticoagulation
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04048434


Contacts
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Contact: Sascha David, MD +495115329357 david.sascha@mh-hannover.de
Contact: Klaus Stahl, MD +495115327623 stahl.klaus@mh-hannover.de

Locations
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Germany
Hannover Medical School Recruiting
Hannover, Germany
Contact: Klaus Stahl, MD         
Switzerland
Universitätsspital Zürich (USZ) Recruiting
Zürich, Switzerland
Contact: Sascha David, MD         
Sponsors and Collaborators
Hannover Medical School
CytoSorbents, Inc
Investigators
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Principal Investigator: Sascha David, MD Hannover Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT04048434    
Other Study ID Numbers: CRS01
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
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: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Syndrome
Cytokine Release Syndrome
Disease
Pathologic Processes
 Systemic Inflammatory Response Syndrome
Inflammation
Shock