Tocilizumab Acute Chest

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

We 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, we are hopeful that this will be an effective strategy. We 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago

Criteria

Inclusion Criteria:

• Adults ≥ 18 years of age

• Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

• Admission in the past 5 years to the University of Chicago for acute chest syndrome (IRB21-2036) with outpatient hematologist agreement to screen, enrollment in the University of Chicago Sickle Cell Registry (16607A), or current admission to the University of Chicago for acute chest syndrome. Although patients with an admission in the past 5 years or on the Sickle Cell Registry will be registered and consented in the outpatient setting, randomization will only occur when a subject is admitted for ACS.

Exclusion Criteria:

• Pregnant patients or breastfeeding mothers.

• 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