Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 48 visits
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "After randomization, participants will have injection/safety visits at Week 0, Week 12, Week 24, and Week 36."
- "Repeat imaging assessments for vascular inflammation will occur during the Week 48 visit(s)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether canakinumab lowers swelling and irritation in blood vessels. It is for adults with disease in the arteries that supply the heart, with or without changes in a gene called TET2.
The primary goal of this clinical trial is to test the hypothesis that the drug canakinumab (anti-IL-1B monoclonal antibody) decreases vascular inflammation when used by people with a history of coronary artery disease, including those with and without TET2 mutations.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be 18 or older.
- You must have had a heart attack, a heart artery stent placed more than 180 days before study scans, or advanced heart artery disease found on a scan.
- Past gene testing must show either TET2 changes or no myeloid driver mutations—certain gene changes in blood-forming cells.
- If you have TET2-related MDS or dysplastic-type CMML, which are blood disorders, your risk score for the disease getting worse must be low enough: IPSS-M of 0 or less.
- For those blood disorders, immature blood cells must be below 2% in blood and below 5% in bone marrow.
- For those blood disorders, blood counts must meet these limits: white blood cells below 13, neutrophils (infection-fighting cells) at least 1.0, and platelets (clotting cells) at least 50, all measured in billions per liter. Hemoglobin, which carries oxygen, must be at least 10 g/dL.
- For those blood disorders, you must have received fewer than 2 units of red blood cells and no platelets in the past 8 weeks. Transfusions for short-term problems, such as surgery or bleeding, do not count.
- For those blood disorders, your cancer doctor must judge the disease stable and not expect you to need treatment to change its course within 24 months.
Who can't join
- A drug-coated stent placed near the start of a heart artery less than 180 days before study scans, or any past heart bypass surgery.
- Pregnancy or breastfeeding; a history of blood cancer; a current cancer forming a solid tumor; or a past organ or stem cell transplant.
- Current prescription steroids or medicines that lower inflammation or immune activity taken by mouth or injection, including colchicine. Recent use also excludes you: pills for more than 7 days in the past month, or injections in the past 3 months. Skin treatments, UV therapy, aspirin-related drugs, and NSAIDs do not count.
- Allergy to dextrans, DTPA, or radioactive metals, or a severe allergy to iodine-based scan dye; kidney function below the study limit (eGFR below 45); or significant radiation exposure (40 mSv) in the past year.
- A reason you cannot take nitroglycerin, narrow-angle glaucoma (an eye condition), or severe narrowing of the aortic heart valve. Taking a PDE5 inhibitor and refusing to stop it for 5 days before the heart CT scan also excludes you.
- Active or repeated liver disease, including cirrhosis (liver scarring), liver enzymes above 3 times normal, or bilirubin above 2 times normal.
- Past or current tuberculosis (TB), inactive TB, or TB risk factors; a current infection or repeated infections; or a suspected or confirmed weakened immune system.
- A live vaccine within 3 months before random assignment to treatment, or one planned during the trial; or another research study that the study team thinks would interfere.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 18 years or older * Coronary artery disease, defined as prior heart attack, coronary stent procedure \>180 days before baseline imaging, or advanced subclinical coronary atherosclerosis (coronary artery calcium score ≥300 Agatston units, CAD-RADS 3 or greater atherosclerosis on coronary CT angiography, or qualitatively severe coronary artery calcification identified on non-gated CT imaging) * Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing * TET2-mutant myelodysplastic syndrome (MDS) or dysplastic-type chronic myelomonocytic leukemia (CMML) participants only must meet all of the following criteria: * Very low, low, or moderate-low risk for disease progression according to IPSS-M (score ≤0) * Peripheral blood blasts \<2% and bone marrow blasts \<5% * WBC \<13 ×10⁹/L * ANC ≥1.0 ×10⁹/L * Hemoglobin ≥10 g/dL * Platelet count ≥50 ×10⁹/L * No clinically significant transfusion requirement attributable to MDS/CMML, defined as receipt of \<2 units of RBCs and no platelet transfusions during the 8 weeks preceding screening (excluding transfusions for acute bleeding, surgery, or another transient intercurrent condition) * In the judgment of the treating oncologist, clinically stable disease for which disease-modifying therapy is not anticipated to be required within the subsequent 24 months Exclusion Criteria: * placement of a drug-eluting stent in a proximal coronary arterial segment \<180 days before baseline imaging * prior coronary artery bypass grafting * pregnancy or breastfeeding * history of blood malignancy or current solid-tumor malignancy * history of organ or stem cell transplantation * current treatment with prescription, systemic (oral, IV \[intravenous\], or IM \[intramuscular\]) steroids or anti-inflammatory/immune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases, post-transplant care, asthma, or pain * use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 1 month * use of IV or IM steroids or IV or IM anti-inflammatory/immune suppressant medication within the past 3 months * known allergy to dextran's and/or DTPA and/or radiometals and/or severe allergy to iodinated contrast media * estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m2 * contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis * use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan * significant radiation exposure (40msV) received within the past 12 months * concurrent enrollment in another research study judged by the investigators to interfere with the current study * known active or recurrent hepatic disease (including cirrhosis or ALT/AST levels \>3 times the upper limit oof or total bilirubin \>2 times the upper limits of normal) * history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB * active bacterial, fungal or viral infection at the time of enrollment or history of recurrent infections * suspected or proven immunocompromised state * live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Victoria R Viscosi, MS · Study contact · 617-724-2996 · vviscosi@mgh.harvard.eduJack H.A. Miller, BS · Study contact · 617-643-7546 · jmiller90@mgh.harvard.eduMichael C Honigberg, MD, MPP · Principal investigatorMore trials in Boston