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Siltuximab for Cytokine Release Syndrome

University of Alabama at Birmingham, Birmingham, AL
Cytokine Release Syndrome+14 More ConditionsSiltuximab - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test whether siltuximab can lessen the severity of CRS and ICANS in patients receiving CAR T-cell therapy for blood cancer.

Eligible Conditions
  • Cytokine Release Syndrome
  • Multiple Myeloma
  • Acute Lymphoblastic Leukemia
  • Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
  • Cytokine Storm
  • Cytokine Release Syndrome (CRS)
  • Hypercytokinemia
  • Non-Hodgkin Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Siltuximab
1
Tadekinig alfa (IL-18BP)
1
Itacitinib

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline through day 90

Baseline through 14 days
Participants with a complete response for cytokine release syndrome (CRS)
Baseline through 28 days
Participants experiencing adverse events from Siltuximab
Participants with a response for Immune effector Cell Associated Neurotoxicity Syndrome (ICANS)
Baseline through day 90
Participants with response to CAR T-cell therapy

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Siltuximab
1
Tadekinig alfa (IL-18BP)
1
Itacitinib

Side Effects for

Tocilizumab
10%Lung infection
10%Constipation
9%Alanine aminotransferase increased
7%Respiratory failure
6%Aspartate aminotransferase increased
4%Gastroparesis
4%Hyperkalaemia
4%Other
4%Hypertension
4%Thromboembolic event
2%Hyperglycaemia
2%Multi-organ failure
2%Anaemia
2%Diarrhoea
2%Delirium
2%Sepsis
2%GGT increased
2%Sinus bradycardia
1%Cardiac arrest
1%postoperative haemorrhage
1%Neutrophil count decreased
1%Cough
1%Pneumothorax
1%Hypertriglyceridaemia
1%Stroke
1%Asystole
1%Hypotension
1%Acute kidney injury
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04330638) in the Tocilizumab ARM group. Side effects include: Lung infection with 10%, Constipation with 10%, Alanine aminotransferase increased with 9%, Respiratory failure with 7%, Aspartate aminotransferase increased with 6%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Siltuximab
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Siltuximab · No Placebo Group · Phase 2

Siltuximab
Drug
Experimental Group · 1 Intervention: Siltuximab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siltuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through day 90

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,475 Previous Clinical Trials
2,246,197 Total Patients Enrolled
1 Trials studying Cytokine Release Syndrome
15 Patients Enrolled for Cytokine Release Syndrome
Mayur S NarkhedePrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the estimated number of participants included in this research?

"Confirmed. According to the records on clinicaltrials.gov, this trial is actively searching for 30 enrollees at 1 medical centre - with its first posting date being November 15th 2021 and its final edit occurring two days later." - Anonymous Online Contributor

Unverified Answer

What prior experiments have explored the efficacy of Siltuximab?

"Currently, 4 different trials are observing the effects of siltuximab. Not one is in its final phase 3; however there are 6 sites across New York City that have started testing this medication's efficacy." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial currently have openings for participants?

"Affirmative. The clinical trial data hosted on clinicialtrials.gov verifies that this experiment commenced recruitment as of November 15th 2021 and was most recently revised on the 17th of November 2021. Currently, 30 individuals are needed for participation at a single medical site." - Anonymous Online Contributor

Unverified Answer

What evidence exists for the safety of Siltuximab in humans?

"Our team has determined that siltuximab's safety score is a 2, as the drug is currently in its second phase of clinical trials and there are data points that suggest it can be safe but none to support its effectiveness." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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