Phase II Study of Canakinumab to Prevent Blood Cancer Progression in Adults With High-Risk Clonal Cytopenias of Unknown Significance CCUS

What this Trial Is About

Researchers are evaluating canakinumab in a phase II trial to see if it can help prevent the progression to blood cancers in patients with clonal cytopenias of unknown significance CCUS. CCUS is a condition where blood cell counts remain low over time due to genetic mutations affecting blood cell development, increasing the risk of developing myeloid cancers. The study aims to understand how blocking inflammation with canakinumab, a monoclonal antibody targeting interleukin-1beta, may influence this risk. Participants are randomly assigned to receive either canakinumab or a placebo through subcutaneous injections. Both groups undergo extensive monitoring including echocardiograms, chest x-rays, blood sample collections, and bone marrow biopsies and aspirations during the trial. The study collects data on blood responses, mutation changes, infection rates, cardiovascular events, and quality of life over time. Throughout the study, participants will have regular assessments of their blood cell counts, genetic mutation levels, immune system markers, and inflammatory signals from blood and bone marrow samples. Researchers will follow participants for up to six years to measure the time until blood cancer develops and to evaluate overall survival, response to treatment, and side effects. Patient-reported quality of life and cardiac health are also monitored as part of the study.

Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study