NCT04048434

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

August 6, 2019

Last Update Submit

March 26, 2021

Conditions

Cytokine Release SyndromeCAR-T

Outcome Measures

Primary Outcomes (1)

  • IL-6 change

    24 hours

Study Arms (2)

Standard of care (SOC)

NO INTERVENTION

Cyotosorb

EXPERIMENTAL
Device: Cytosorb

Interventions

CytosorbDEVICE

extracorporeal cytokine adsorption

Cyotosorb

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe CRS (\> 3) and / or severe CRES (\>3)
  • AND
  • \- CRS/CRES onset \< 6 hrs

You may not qualify if:

  • Heparine allergy
  • contraindication for anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hannover Medical School

Hanover, Germany

RECRUITING

Universitätsspital Zürich (USZ)

Zurich, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32113143DERIVED

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Sascha David, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha David, MD

CONTACT

+495115329357david.sascha@mh-hannover.de

Klaus Stahl, MD

CONTACT

+495115327623stahl.klaus@mh-hannover.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

June 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)CH(1)