Tocilizumab for Acute Chest Syndrome
Recruiting · NCT05640271 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.
Who can take part
Inclusion criteria
- Adults ≥ 12 years of age
- Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)
Exclusion criteria
- Pregnant patients or breastfeeding mothers.
- Prior treatment with gene therapy or a stem cell transplant.
- Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.
- Current neutropenia (absolute neutrophil count \< 1000/mm\^3)
- Current thrombocytopenia (platelet count \< 50,000 mm\^3)
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 10 times the upper limit of normal (ULN)
- History of tuberculosis (TB).
- Positive purified protein derivative (PPD) TB screening test.
- On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib
- On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib
- Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:
- Abatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab
Where it is running
1 location listed across 1 US state.
- University of Chicago - Chicago, Illinois, United States