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

Locations

6
University of Miami33136, MiamiFlorida, United States
Memorial Sloan Kettering Cancer Center10065, New YorkNew York, United States
Weill Cornell Medical College10021, New YorkNew York, United States
Ohio State University Comprehensive Cancer Center43210, ColumbusOhio, United States

Sponsors and collaborators

Uma Borate

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution