Study on Canakinumab to Prevent Cancer in Patients with Clonal Cytopenias of Unknown Significance (IMPACT Study)

Sponsor: Uma Borate

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05641831

Provider View

This clinical trial is testing whether the drug canakinumab can help prevent the progression to cancer in patients with a blood condition called clonal cytopenias of unknown significance (CCUS), which involves low blood cell counts and genetic mutations that increase cancer risk.

Patient Parameters

Program Overview

This study is exploring if canakinumab, a medication that may reduce inflammation, can prevent the development of blood cancers in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a condition where patients have low counts of blood cells, such as red or white blood cells and platelets, along with genetic mutations that increase their risk of developing blood cancers. The study aims to see if canakinumab can block inflammation that might lead to cancer.

Description

The main goal of this study is to see how long it takes for patients with high-risk CCUS to develop certain types of blood cancers, like myelodysplastic syndrome or acute myeloid leukemia, when treated with canakinumab compared to a placebo. Researchers will also look at how canakinumab affects blood cell counts, overall survival, and the occurrence of infections and cardiovascular events. Patients will be randomly assigned to receive either canakinumab or a placebo, and will undergo various tests, including blood samples and bone marrow biopsies, throughout the study to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with high-risk CCUS.
  • Must have unexplained low blood cell counts for more than 4 months in red blood cells, white blood cells, or platelets.
  • No diagnosis of myelodysplastic syndrome or other blood cancers.
  • No significant bone marrow abnormalities.
  • Specific genetic mutations related to blood cell development.
  • Ability to understand and sign informed consent.
  • Good overall health with a performance status of 0, 1, or 2.
  • Controlled blood pressure and adequate kidney and liver function.

Exclusion Criteria

  • Current cancer requiring treatment.
  • History of myelodysplastic syndrome or other blood cancers.
  • Allergy to canakinumab or similar drugs.
  • Active or recurrent infections.
  • Liver disorders or active hepatitis B or C.
  • Active tuberculosis or immunocompromised state.
  • Recent live vaccinations.
  • Use of certain medications affecting the immune system.
  • Pregnant or nursing women, or women not using effective contraception.

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