Statins for CCUS and Lower-Risk MDS
This study is exploring if common medications called statins, specifically Atorvastatin and Rosuvastatin, can help patients with Clonal Cytopenia of Undetermined Significance (CCUS) or lower-risk Myelodysplastic Syndromes (MDS). These conditions can sometimes progress to more serious blood cancers or lead to heart problems. Researchers want to see if statins, which are known to help with heart health and have shown promise in lab studies for blood cancers, can improve outcomes. The study will measure changes in a specific protein (hs-CTRP levels) in your blood to see if the statins are having an effect. You may be eligible if you are 18 or older and have a diagnosis of CCUS or lower-risk MDS. The current status of this study is unclear.
- Study design
- This is a pilot study with a planned enrollment of 16 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- You would have blood tests at the start of the study, every 3 months while on treatment, at the end of treatment, and 3 months after treatment ends. There will also be a test at the time of disease progression, if it occurs.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after the end of treatment and at the time of progression, which is estimated to be 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05483010
Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS)
Recruiting
PHASE2Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~16 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:AtorvastatinRosuvastatin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in hs-CTRP levels in peripheral blood during statin therapy
Measured over Pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months)
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Amber Afzal, M.D., MSCI · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of CCUS or lower-risk MDS as defined below:
CCUS is defined as the presence of somatic mutation(s) in recurrently mutated genes identified through the clinical MyeloSeq assay with a VAF ≥ 2% in the absence of bone marrow morphology/cytogenetic changes diagnostic of MDS PLUS unexplained persistent cytopenia in at least one lineage for at least 6 months:
Hemoglobin \< 11.3 g/dL in females or \< 13 g/dL in males
ANC \< 1.8 x 109/L
Platelets \< 150 x 109/L
MDS is defined using the WHO 2016 definition and classified into lower-risk if IPSS-R score is ≤ 3.5 . Lower-risk MDS will be required to have at least one mutation in a recurrent mutated gene with a VAF ≥ 2%.
Patient must be transfusion independent.
At least 18 years of age.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
CCUS patients with cytogenetic change alone.
Current or prior use of disease-modifying therapy (e.g., lenalidomide, Luspatercept, Imitelstat, HMAs, venetoclax) with any dose within the last 3 months, with the exception of concurrent use of erythropoetin stimulating agents
Prior use of a statin within 1 year prior to start of treatment.
A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence active of disease.
Currently receiving any investigational agent for CCUS/MDS. The minimum interval between the last dose of investigational agent used for CCUS/MDS and Day 1 of this trial should be 5 half-lives of the investigational agent.
A history of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to atorvastatin, rosuvastatin, any other statin, or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, symptomatic infection, sepsis, or active liver disease (acute liver failure, decompensated cirrhosis, or persistent elevation in ALT or AST \> 3 x ULN), or any other comorbidity that would preclude statin use based on FDA recommendation.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Patients with HIV and HCV are not eligible for the trial if they are concomitantly receiving active treatment for HIV/HCV given the concern for potential drug interactions. The minimum interval between the last dose of antiviral and enrollment into the study should be 28 days or 5 half-lives of the antiviral drug, whichever is longer. The liver function profile of eligible HIV/HCV patients must be within the acceptable limits.
What this trial measures
- Change in hs-CTRP levels in peripheral blood during statin therapyPre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months)