CYTORELEASE: Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)
Sponsor
Hannover Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT04048434
Collaborator
CytoSorbents, Inc (Industry)
34
2
2
39
17
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date
:
Jun 1, 2021
Anticipated Primary Completion Date
:
Sep 1, 2023
Anticipated Study Completion Date
:
Sep 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of care (SOC)
|
|
| Experimental: Cyotosorb
|
Device: Cytosorb
extracorporeal cytokine adsorption
|
Outcome Measures
Primary Outcome Measures
- IL-6 change [24 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hannover Medical School | Hannover | Germany | ||
| 2 | Universitätsspital Zürich (USZ) | Zürich | Switzerland |
Sponsors and Collaborators
- Hannover Medical School
- CytoSorbents, Inc
Investigators
- Principal Investigator: Sascha David, MD, Hannover Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT04048434
Other Study ID Numbers:
- CRS01
First Posted:
Aug 7, 2019
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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: