A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study
Uma Borate
Summary
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).
Description
PRIMARY OBJECTIVE: I. To evaluate the length of time until development of a myeloid neoplasm (ie myelodysplastic syndrome \[MDS\], myeloproliferative neoplasm \[MPN\], chronic myelomonocytic leukemia \[CMML\], or acute myeloid leukemia \[AML\]) in high-risk clonal cytopenia of undetermined significance (CCUS) patients receiving canakinumab as therapeutic intervention compared to the control arm. SECONDARY OBJECTIVES: I. To determine the effect of canakinumab on hematological overall response rate. II. To determine the effect of canakinumab on complete hematological response rate. III. To…