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The purpose of this study is to test the benefit and safety of Canakinumab for Clonal Cytopenia of Undetermined 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).
Canakinumab is experimental, which means that it is being tested for Clonal Cytopenia of Undetermined Significance (CCUS) and is not yet approved by the United States Food and Drug Administration (FDA).
In this study, participants will receive canakinumab or placebo at dose 300 mg subcutaneously every three months for two years.
• Open to men and women above the age of 18 who have been diagnosed with high-risk Clonal Cytopenia of Undetermined Significance (CCUS).
• Participants must not have a diagnosis of Myelodysplastic syndrome (MDS), Myeloproliferative Neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), Acute Myeloid Leukemia (AML) or any other myeloid malignancy.
• Detailed eligibility will be reviewed when you contact the study team.
Upper East Side - Manhattan
Open to Enrollment
