Using tocilizumab to treat acute chest syndrome in sickle cell disease
Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease
This study is testing if a low dose of tocilizumab can help people with sickle cell disease who have acute chest syndrome feel better during their hospital stay.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab, Acalabrutinib, Ibrutinib, Zanubrutinib, Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib, CAR-T, chimeric antigen receptor |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05640271 on ClinicalTrials.gov |
What this trial studies
This phase II interventional study evaluates the effectiveness of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Participants aged 12 and older will be randomly assigned to receive either tocilizumab or a placebo, with doses administered intravenously. The study will monitor oxygen levels, clinical outcomes, and laboratory markers over the course of hospitalization. The goal is to determine if tocilizumab can improve patient outcomes by targeting elevated interleukin-6 levels associated with acute chest syndrome.
Who should consider this trial
Good fit: Ideal candidates are adults aged 12 and older with a prior diagnosis of sickle cell disease.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as neutropenia or thrombocytopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and clinical outcomes for patients experiencing acute chest syndrome due to sickle cell disease.
How similar studies have performed: While the use of tocilizumab has shown promise in other conditions, this specific application for acute chest syndrome in sickle cell disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Austin Wesevich, MD — University of Chicago
- Study coordinator: Austin Wesevich, MD
- Email: austin.wesevich@uchicagomedicine.org
- Phone: 773-834-6732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.