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NCT05641831 · ClinicalTrials.gov registry record · Phase 2
Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
A Phase 2 study of Clonal Cytopenia of Undetermined Significance, sponsored by Uma Borate.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 6
- Study locations
NCT05641831: Recruiting Phase 2 study of Clonal Cytopenia of Undetermined Significance, sponsored by Uma Borate.
NCT05641831 is a Phase 2 study of Clonal Cytopenia of Undetermined Significance that is actively recruiting participants, run by Uma Borate. The registered enrollment target is 110 participants, below the 426-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (74% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05641831, a Phase 2 study of Clonal Cytopenia of Undetermined Significance, is actively recruiting participants, sponsored by Uma Borate.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 6
- Study locations
Study Summary
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).
Primary Outcome
Will be estimated with the non-parametric Kaplan-Meier method to compute the median time as well as the percentage of study participants with a diagnosed hematologic malignancy of myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML)/ acute myeloid leukemia (AML) at landmark time points (e.g., 1-year, 2-years) with corresponding 95% confidence intervals. Since this method will censor patients who die without having developed MDS/MPN/CMML/AML, w
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Canakinumab
- PROCEDURE Chest Radiography
- PROCEDURE Bone Marrow Aspiration and Biopsy
- PROCEDURE Echocardiography
Study Locations (6)
New York
- Weill Cornell Medical College - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- University of Miami - Miami
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- UT Southwestern Medical Center at Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05641831 shows while recruiting
NCT05641831 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 426-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Clonal Cytopenia of Undetermined Significance appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05641831 lists 6 locations in 5 states (New York, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT05641831 about?
NCT05641831 is a clinical study titled "Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study". 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...
What is the current status of trial NCT05641831?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2023-02-06. Estimated completion is 2028-12-31.
What conditions does trial NCT05641831 study?
This clinical trial studies the following conditions: Clonal Cytopenia of Undetermined Significance.
What interventions are being tested in trial NCT05641831?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Canakinumab (DRUG), Chest Radiography (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Echocardiography (PROCEDURE).
Who is sponsoring clinical trial NCT05641831?
This trial is sponsored by Uma Borate, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05641831 being conducted?
This trial has 6 study locations across Florida, New York, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05641831's enrollment target sits among peer trials
110 4th of 11 higher than 8 of 11 other Clonal Cytopenia of Undetermined Significance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clonal Cytopenia of Undetermined Significance trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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