RECRUITING

Tocilizumab for Acute Chest Syndrome

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Conditions

Sickle Cell DiseaseAcute Chest Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-10
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05640271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥ 12 years of age
  2. * Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)
  1. * Pregnant patients or breastfeeding mothers.
  2. * Prior treatment with gene therapy or a stem cell transplant.
  3. * Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.
  4. * Current neutropenia (absolute neutrophil count \< 1000/mm\^3)
  5. * Current thrombocytopenia (platelet count \< 50,000 mm\^3)
  6. * Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 10 times the upper limit of normal (ULN)
  7. * History of tuberculosis (TB).
  8. * Positive purified protein derivative (PPD) TB screening test.
  9. * On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib
  10. * On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib
  11. * Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:

Contacts and Locations

Study Contact

Austin Wesevich, MD
CONTACT
773-834-6732
austin.wesevich@uchicagomedicine.org
Gabrielle Lapping-Carr, MD
CONTACT
773-702-6808
glappingcarr@uchicago.edu

Principal Investigator

Austin Wesevich, MD
STUDY_DIRECTOR
University of Chicago

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Austin Wesevich, MD, STUDY_DIRECTOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-04-10
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Sickle Cell Disease
  • Acute Chest Syndrome