A Phase 2 Study of Canakinumab in People With Clonal Cytopenia of Unknown Significance

Full Title

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

Purpose

Researchers want to learn if canakinumab can prevent cancer from developing in people with clonal cytopenia of undetermined significance (CCUS). In CCUS, there is a mutation (change) in one or more of the genes that help blood cells develop. People with CCUS have low levels of certain kinds of blood cells.

CCUS can lead to precancerous conditions such as myelodysplastic syndrome or blood cancers such as acute myeloid leukemia. The combination of your genetic mutation and low blood cell counts from CCUS raises your risk of developing blood cancer. People with CCUS also have a higher risk of heart disease. At the current time, there is no treatment for CCUS.

Canakinumab is a drug that may reduce inflammation. Inflammation can contribute to the development of blood cancers and heart disease. If you join this study, you will be randomly assigned to get either canakinumab or a placebo (inactive drug). Both are given as an injection under the skin.

Who Can Join

To join this study, there are a few conditions. You must:

• Have CCUS and a high risk of developing a blood cancer or precancer.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Tamanna Haque’s office at 646-608-4166.