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Recruiting Phase 2

Tocilizumab for Acute Chest Syndrome

About this study

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.

Condition
Sickle Cell Disease, Acute Chest Syndrome
Tested
Tocilizumab
Sponsor
University of Chicago

Who can join

Age
12 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 4

  • Minimum age: 12 years
  • Study condition: Sickle Cell Disease, Acute Chest Syndrome
  • Adults ≥ 12 years of age
  • Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Exclusion 12

  • 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

1 site, 1 recruiting

University of Chicago

Chicago, Illinois, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.