RecruitingPhase 2NCT05641831

Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study

A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study


Sponsor

Uma Borate

Enrollment

110 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Bone Marrow Aspiration and Biopsy, and others for people with clonal cytopenia of undetermined significance. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo peripheral blood collection

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

DRUGCanakinumab

Given SC

PROCEDUREChest Radiography

Undergo chest x-ray

PROCEDUREEchocardiography

Undergo ECHO

DRUGPlacebo Administration

Given SC

OTHERQuality-of-Life Assessment

Ancillary studies


Locations(6)

University of Miami

Miami, Florida, United States

Weill Cornell Medical College

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05641831


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