Extracorporeal Cytokine Adsorption as Additive Treatment... | NCT04048434

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

NCT04048434

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Apr 1, 2021Actual

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Cytokine Release Syndrome
CAR-T

Interventions

Cytosorb

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2021Estimated

Primary Completion Date

Sep 2023Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Aug 6, 2019

First Submission Date that Met QC Criteria

Aug 6, 2019

First Posted Date

Aug 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2021

Last Update Posted Date

Apr 1, 2021Actual

Name	Class
CytoSorbents, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care (SOC)	No Intervention
Cyotosorb	Experimental		Device: Cytosorb

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytosorb	Device	extracorporeal cytokine adsorption	Cyotosorb

Measure	Description	Time Frame
IL-6 change		24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sascha David, MD	Contact	+495115329357		david.sascha@mh-hannover.de
Klaus Stahl, MD	Contact	+495115327623		stahl.klaus@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Sascha David, MD	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School	Recruiting	Hanover			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32113143	Derived	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.

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms