What this study is
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.
What's being tested
- Tocilizumab
Intervention · DRUG
Tocilizumab 80 mg IV dose (one time per patient)
Study details
- Official title
- Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease
- Sponsor
- University of Chicago
- Conditions
- Sickle Cell Disease · Acute Chest Syndrome
- Enrolling
- 200 people
- Starts
- 2023-04-10
- Est. completion
- 2027-06
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults ≥ 12 years of age
- Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Chicago
Chicago, Illinois, United States
- Austin Wesevich, MD · Contact773-834-6732austin.wesevich@uchicagomedicine.org
Recruiting
Study team
Sponsor
University of Chicago
Study ID IRB22-0277
Principal investigator
Gabrielle Lapping-Carr, MD
University of Chicago
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.