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Studies

Interventional Recruiting

NCT04048434 on ClinicalTrials.gov

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

Official title: Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)

  • Sponsor: Hannover Medical School
  • Collaborators: CytoSorbents, Inc
  • Enrollment: 34 (Estimated)
  • Study start: 2021-06-01 (Estimated)
  • Primary completion: 2023-09-01 (Estimated)
  • Study completion: 2024-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Participant)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Cytokine Release Syndrome
  • CAR-T

Intervention / Treatment

  • Device: Cytosorb

Primary Outcome Measures

  • IL-6 change (24 hours)

Countries

Germany, Switzerland

Locations and Investigators

  • Hannover Medical School, Hannover, Germany (Recruiting)
    • Klaus Stahl, MD
  • Universitätsspital Zürich (USZ), Zürich, Switzerland (Recruiting)
    • Sascha David, MD

Study Officials