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

NCT05641831 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-02

No results posted yet for this study

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).

Conditions

  • Clonal Cytopenia of Undetermined Significance

Interventions

PROCEDURE

Biospecimen Collection

Undergo peripheral blood collection

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

DRUG

Canakinumab

Given SC

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Placebo Administration

Given SC

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • Uma Borate

    lead OTHER

Principal Investigators

  • Uma M Borate, MD, MS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641831 on ClinicalTrials.gov