RecruitingPhase 2NCT05640271

Tocilizumab for Acute Chest Syndrome

Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease

Sponsor

University of Chicago

Enrollment

200 participants

Start Date

Apr 10, 2023

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease Acute Chest Syndrome

Summary

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.

Eligibility

Min Age: 12 Years

Inclusion Criteria2

Adults ≥ 12 years of age
Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Exclusion Criteria12

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 \&lt; 1000/mm\^3)
Current thrombocytopenia (platelet count \&lt; 50,000 mm\^3)
Aspartate aminotransferase (AST) or alanine transaminase (ALT) \&gt; 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