Actively Recruiting
Canakinumab to Prevent Leukemic Progression in Patients With Clonal Cytopenias of Unknown Significance A Randomized Double-Blind Placebo-Controlled Phase II Study
Led by Uma Borate · Updated on 2026-01-02
110
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating canakinumab in a phase II trial to see if it can help prevent the progression to blood cancers in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a condition where blood cell counts remain low over time due to genetic mutations affecting blood cell development, increasing the risk of developing myeloid cancers. The study aims to understand how blocking inflammation with canakinumab, a monoclonal antibody targeting interleukin-1beta, may influence this risk. Participants are randomly assigned to receive either canakinumab or a placebo through subcutaneous injections. Both groups undergo extensive monitoring including echocardiograms, chest x-rays, blood sample collections, and bone marrow biopsies and aspirations during the trial. The study collects data on blood responses, mutation changes, infection rates, cardiovascular events, and quality of life over time. Throughout the study, participants will have regular assessments of their blood cell counts, genetic mutation levels, immune system markers, and inflammatory signals from blood and bone marrow samples. Researchers will follow participants for up to six years to measure the time until blood cancer develops and to evaluate overall survival, response to treatment, and side effects. Patient-reported quality of life and cardiac health are also monitored as part of the study.
CONDITIONS
Brief 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 18 years or older with high-risk clonal cytopenias of undetermined significance (CCUS)
- Unexplained low blood cell counts lasting more than 4 months in erythroid cells, neutrophils, or platelets
- Blood cell counts meeting institution-specific thresholds, including hemoglobin < 11 g/dL, neutrophils between 500 and 1800/microL, or platelets between 50,000 and 150,000/microL
- No diagnosis of myelodysplastic syndrome (MDS) or other blood cancer
- Bone marrow with no or mild dysplasia (< 10%) and blast cells less than 5%
- Presence of specific gene mutations related to myeloid malignancy as defined by study criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate kidney function with creatinine clearance > 45 ml/min
- Liver function tests within specified limits: total bilirubin ≤ 1.5 x upper limit normal, AST and ALT < 3 x upper limit normal
- Ability to understand and sign informed consent
- Patients with history or active hypertension encouraged to optimize blood pressure control
You will not qualify if you...
- Active cancer requiring systemic therapy
- Previous diagnosis of MDS or any myeloid cancer
- Allergy or hypersensitivity to canakinumab or similar drugs
- Active infection needing treatment or history of recurrent infections
- Known active or recurrent liver disease including cirrhosis or hepatitis B/C
- Active tuberculosis or untreated past tuberculosis
- Suspected or proven immunocompromised state or serious infections
- Positive HIV infection or testing positive during screening in countries requiring HIV status
- History of bone marrow or solid organ transplant
- Use of systemic steroids or immunosuppressive drugs above study limits
- Live or attenuated vaccination within 3 months before study drug or after starting treatment
- Use of erythropoietin stimulating agents or growth factors within 4 weeks prior to study
- Pregnant or nursing women; women of child-bearing potential must use approved contraception methods during and after the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 6 years
Participants receive either canakinumab or placebo by subcutaneous injection. Blood samples and bone marrow biopsies are collected during treatment to monitor response and safety.
Regular visits for treatment administration and assessments throughout the study period
Duration - Up to 6 years
Participants continue to have blood samples collected and bone marrow biopsies performed to monitor for disease progression and long-term effects after treatment ends.
Scheduled follow-up visits for blood and bone marrow sample collection
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
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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