Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
Public ClinicalTrials.gov record NCT05641831. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).
Study identification
- NCT ID
- NCT05641831
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 110 participants
Conditions and interventions
Interventions
- Biospecimen Collection Procedure
- Bone Marrow Aspiration and Biopsy Procedure
- Canakinumab Drug
- Chest Radiography Procedure
- Echocardiography Procedure
- Placebo Administration Drug
- Quality-of-Life Assessment Other
Procedure · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2023
- Primary completion
- Dec 30, 2028
- Completion
- Dec 30, 2028
- Last update posted
- Jan 1, 2026
2023 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Weill Cornell Medical College | New York | New York | 10021 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05641831, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 1, 2026 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05641831 live on ClinicalTrials.gov.