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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUma Borate

About this trial

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 criteria

Qualifiers

Patients with age >= 18 with high-risk CCUS

Hemoglobin < 11 g/dL

Absolute Neutrophil Count < 1800/microL and > 500/microL

Platelet Count < 150,000/microL and > 50,000/microL

Disqualifiers

Concurrent malignancy requiring active systemic therapy

Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime

History of Hypersensitivity to canakinumab or drug of a similar class

Active infection requiring prompt evaluation and treatment or history of recurrent infections

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration and Biopsy
  • Canakinumab
  • Chest Radiography
  • Echocardiography
  • Placebo Administration
  • Quality-of-Life Assessment

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Uma Borate

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution