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

Primary Purpose

Cytokine Release Syndrome, CAR-T

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Cytosorb

About this trial

This is an interventional treatment trial for Cytokine Release Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

AND

- CRS/CRES onset < 6 hrs

Exclusion Criteria:

Heparine allergy
contraindication for anticoagulation

Sites / Locations

Hannover Medical SchoolRecruiting
Universitätsspital Zürich (USZ)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care (SOC)

Cyotosorb

Arm Description

Outcomes

Primary Outcome Measures

IL-6 change

Secondary Outcome Measures

Full Information

NCT ID

NCT04048434

First Posted

August 6, 2019

Last Updated

March 26, 2021

Sponsor

Hannover Medical School

Collaborators

CytoSorbents, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04048434

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 2021 (Anticipated)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hannover Medical School

Collaborators

CytoSorbents, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytokine Release Syndrome, CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of care (SOC)

Arm Type

No Intervention

Arm Title

Cyotosorb

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Cytosorb

Intervention Description

extracorporeal cytokine adsorption

Primary Outcome Measure Information:

Title

IL-6 change

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: severe CRS (> 3) and / or severe CRES (>3) AND - CRS/CRES onset < 6 hrs Exclusion Criteria: Heparine allergy contraindication for anticoagulation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sascha David, MD

Phone

+495115329357

david.sascha@mh-hannover.de

First Name & Middle Initial & Last Name or Official Title & Degree

Klaus Stahl, MD

Phone

+495115327623

stahl.klaus@mh-hannover.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sascha David, MD

Organizational Affiliation

Hannover Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hannover Medical School

City

Hannover

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klaus Stahl, MD

Facility Name

Universitätsspital Zürich (USZ)

City

Zürich

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sascha David, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32113143

Citation

Stahl K, Schmidt BMW, Hoeper MM, Skripuletz T, Mohn N, Beutel G, Eder M, Welte T, Ganser A, Falk CS, Koenecke C, David S. Extracorporeal cytokine removal in severe CAR-T cell associated cytokine release syndrome. J Crit Care. 2020 Jun;57:124-129. doi: 10.1016/j.jcrc.2020.02.010. Epub 2020 Feb 19.

Results Reference

derived

Learn more about this trial

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

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