Trial NCT06691217
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
- Phase
- Phase 2
- Sponsor
- Massachusetts General Hospital
- Conditions
- Vascular Inflammation; ASCVD; ASCVD Management
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 breastfeedingPregnancy
* 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 m2Renal
* 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)Hepatic
* 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
Restrictions found (3)
- HepaticConditionalexclusion
ALT/AST > 3 times ULN; total bilirubin > 2 times ULN
Show in the text - PregnancyOutrightexclusionShow in the text
- RenalOutrightexclusion
eGFR < 45 ml/min/1.73 m2
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County