Cytokine Release SyndromeCYTORELEASENCT04048434
Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)
A study testing Cytosorb in people with Cytokine Release Syndrome and CAR-T, run by Hannover Medical School at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cytokine Release Syndrome, CAR-T
- What is being tested?
- Cytosorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe CRS (> 3) and / or severe CRES (>3)
- AND
- CRS/CRES onset < 6 hrs
Who cannot join
- Heparine allergy
- contraindication for anticoagulation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover
Klaus Stahl, MD
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich (USZ)
Zurich
Sascha David, MD
About this study
Official title: Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)
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
- Being tested
- Cytosorb
- Medical subject headings
- Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytosorbDevice
extracorporeal cytokine adsorption
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SOC) | No intervention | Not described |
| Cyotosorb | Experimental | Not described Receives: Device: Cytosorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 change
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study startJun 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytokine Release SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CytoSorbents, Inc
- Responsible party
- Sponsor
- Investigators
- Sascha David, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048434
- Sponsor's protocol ID
- CRS01
- Acronym
- CYTORELEASE
- Status last verified
- Mar 2021
- First submitted
- 6 Aug 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32113143
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)
- ClinicalTrials.gov ID
- NCT04048434
- Acronym / sponsor ID
- CYTORELEASE / CRS01
- Conditions
- Cytokine Release Syndrome, CAR-T
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- CytoSorbents, Inc
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SOC) | No intervention | – |
| Cyotosorb | Experimental | Device: Cytosorb |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe CRS (> 3) and / or severe CRES (>3)
- AND
- CRS/CRES onset < 6 hrs
Key exclusion criteria (2 listed)
- Heparine allergy
- contraindication for anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytosorbextracorporeal cytokine adsorption | Device | Cyotosorb |
Primary outcome
IL-6 change
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 32113143Stahl 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.
- Individual participant dataSharing planned: No
Related trials for Cytokine Release Syndrome
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Not yet recruiting
Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
Myeloma
RecruitingPhase 2
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 1
CLL-1/CD70 Dual-Target CAR-T Cell Therapy for Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML), Relapsed/Refractory Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha David, MD principal investigator
Hannover Medical School
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosorb in people with Cytokine Release Syndrome and CAR-T, run by Hannover Medical School at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha David, MD (+495115329357, david.sascha@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 change (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.