Tocilizumab for Acute Chest Syndrome

Launched by UNIVERSITY OF CHICAGO · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tocilizumab to see if it can help treat acute chest syndrome in people with sickle cell disease. Acute chest syndrome is a serious condition that can occur in patients with sickle cell disease, and it can cause trouble breathing and low oxygen levels. Tocilizumab works by blocking a protein in the body that can contribute to inflammation, and it has been used for other conditions like rheumatoid arthritis and COVID-19. The researchers want to find out if a low dose of tocilizumab can improve oxygen levels and overall health in patients who are hospitalized for this serious condition.

To be part of this trial, participants need to be at least 12 years old and have a diagnosis of sickle cell disease. However, certain individuals, such as pregnant women, those who have had gene therapy or certain recent treatments, or those with specific health issues, cannot participate. For those who are eligible, they will receive the medication while being closely monitored in the hospital to assess how well it works and if it can make a difference in their recovery. This study is important because it could lead to new treatment options for a challenging complication of sickle cell disease.

Gender

ALL

Eligibility criteria

• 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