Actively Recruiting
Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
Led by Uma Borate · Updated on 2026-01-02
110
Participants Needed
6
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with high-risk CCUS
- Unexplained, clinically meaningful low blood counts lasting more than 4 months in red cells, neutrophils, or platelets
- No diagnosis of myelodysplastic syndrome (MDS)
- No other evidence of blood cancer
- Mild or no bone marrow abnormalities with less than 10% dysplasia
- Blast cells less than 5% in blood or bone marrow
- Presence of specific genetic mutations related to myeloid malignancy as defined by the study
- Ability to understand and sign informed consent
- ECOG performance status of 0, 1, or 2
- Patients with hypertension encouraged to control blood pressure
- Creatinine clearance greater than 45 ml/min
- Liver function tests within specified normal limits
You will not qualify if you...
- Active cancer requiring systemic therapy
- Prior diagnosis of MDS or any myeloid malignancy
- Allergy to canakinumab or similar drugs
- Active infection needing immediate treatment or repeated infections
- Active liver disease including cirrhosis or hepatitis B or C
- Active tuberculosis or untreated history requiring treatment
- Immunocompromised state or infections per investigator's judgment
- HIV positive status where testing is required
- History of bone marrow or solid organ transplant
- Use of high-dose steroids or other immunosuppressive treatments beyond allowed limits
- Live or attenuated vaccines within 3 months before or during treatment
- Use of erythropoietin stimulating agents or growth factors within 4 weeks before study
- Pregnant or nursing women or women not using effective contraception during and after treatment
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
2
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
5
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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