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NCT05483010 · ClinicalTrials.gov registry record · Phase 2
Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS)
A Phase 2 study of Myelodysplastic Syndromes and Clonal Cytopenia of Undetermined Significance, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05483010 is a Phase 2 study of Myelodysplastic Syndromes and Clonal Cytopenia of Undetermined Significance that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05483010, a Phase 2 study of Myelodysplastic Syndromes and Clonal Cytopenia of Undetermined Significance, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Rosuvastatin
- DRUG Atorvastatin
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05483010
The ClinicalTrials.gov registry entry for NCT05483010 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (94% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Rosuvastatin is the first listed.
NCT05483010 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05483010 about?
NCT05483010 is a clinical study titled "Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS)". 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. Cur...
What is the current status of trial NCT05483010?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2024-02-19. Estimated completion is 2027-05-31.
What conditions does trial NCT05483010 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Clonal Cytopenia of Undetermined Significance.
What interventions are being tested in trial NCT05483010?
The interventions under investigation include: Rosuvastatin (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT05483010?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05483010 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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