Pilot Study Evaluating Oral DecitabineCedazuridine Treatment Safety and Early Intervention for Patients With High-Risk Clonal Cytopenia of Undetermined Significance CCUS

What this Trial Is About

Researchers are studying high-risk Clonal Cytopenia of Unknown Significance CCUS to understand the potential risks and benefits of early treatment. This open-label, multicenter pilot trial evaluates the feasibility and safety of using the oral drug decitabinecedazuridine DECCED, which is approved for other conditions but not yet for CCUS. The study is funded by Astex Oncology and supported by lead investigator Dr. Lachelle D. Weeks, MD, PhD. Participants can choose between two groups one receiving the oral drug Inqovi decitabinecedazuridine daily for five days in each 28-day cycle over 12 cycles approximately one year, and another observational group receiving no intervention. The intervention group has frequent clinic visits including bone marrow biopsies and assessments, continuing with a post-treatment observation period for two years. The observation group undergoes periodic assessments and bone marrow biopsies over three years. Participants will have multiple visits for clinical assessments, blood tests, electrocardiograms, echocardiograms, and bone marrow biopsies. Researchers will monitor treatment feasibility, tolerability, hematologic response, mutation changes, inflammatory markers, and quality of life surveys over the course of three years. Safety and disease progression are evaluated regularly during treatment and follow-up periods, with the total participation lasting up to three years.

Early Intervention in High Risk CCUS