Condition: Clonal Cytopenia of Undetermined Significance · Myelodysplastic Syndromes · Sponsor: Washington University School of Medicine
Patients with clonal cytopenia of undetermined significance (CCUS) and lower-risk myelodysplastic syndromes (MDS) have a life expectancy of 5 to 10 years. Mortality in these patients results from progression of disease to higher-risk MDS or acute myeloid leukemia (AML) and cardiovascular events. Currently there are no FDA-approved treatments with the potential to improve survival of patients with CCUS and lower-risk MDS. Statins are an appealing class of drugs to consider in this situation as preclinical data support their potential to suppress progression of myeloid malignancy, and they have a well-established role in prevention of major cardiovascular events. This is a pilot study to explore the role of statins in treatment of patients with CCUS and lower-risk MDS. In this study, change in inflammatory biomarkers and variant allele frequency (VAF) of somatic mutations will be used as a surrogate marker of response to statin therapy. The hypothesis is that the use of statins at diagnosis of CCUS or lower-risk MDS will reduce inflammation and delay or prevent the expected increase in the VAF of somatic mutations over time.
This description comes directly from the study's public registry record.
Amber Afzal, M.D., MSCI · 314-273-0564 · afzalamber@wustl.edu
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| Washington University School of Medicine | St Louis, Missouri, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05483010