About this trial
This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).
Eligibility criteria
Qualifiers
Patients with age >= 18 with high-risk CCUS
Hemoglobin < 11 g/dL
Absolute Neutrophil Count < 1800/microL and > 500/microL
Platelet Count < 150,000/microL and > 50,000/microL
Disqualifiers
Concurrent malignancy requiring active systemic therapy
Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime
History of Hypersensitivity to canakinumab or drug of a similar class
Active infection requiring prompt evaluation and treatment or history of recurrent infections
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration and Biopsy
- Canakinumab
- Chest Radiography
- Echocardiography
- Placebo Administration
- Quality-of-Life Assessment
Treatment groups
Sponsors and collaborators
Uma Borate
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution