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
Uma Borate
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).
Description
PRIMARY OBJECTIVE: I. To evaluate the length of time until development of a myeloid neoplasm (ie myelodysplastic syndrome \[MDS\], myeloproliferative neoplasm \[MPN\], chronic myelomonocytic leukemia \[CMML\], or acute myeloid leukemia \[AML\]) in high-risk clonal cytopenia of undetermined significance (CCUS) patients receiving canakinumab as therapeutic intervention compared to the control arm. SECONDARY OBJECTIVES: I. To determine the effect of canakinumab on hematological overall response rate. II. To determine the effect of canakinumab on complete hematological response rate. III. To…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with age \>= 18 with high-risk CCUS * Must meet ALL the following criteria: * Unexplained, clinically meaningful cytopenias (greater than 4 months) in one or more of the following lineages: erythroid cells, neutrophils, platelets. Clinically meaningful cytopenia is institution specific and threshold may vary on age, sex, and race. Decision-making should depend upon lab values specific to the institution and supersede public works. Based upon published work, significant cytopenias are defined as the following (must meet criteria in at least one lineage):…
Interventions
- ProcedureBiospecimen Collection
Undergo peripheral blood collection
- ProcedureBone Marrow Aspiration and Biopsy
Undergo bone marrow biopsy and aspiration
- DrugCanakinumab
Given SC
- ProcedureChest Radiography
Undergo chest x-ray
- ProcedureEchocardiography
Undergo ECHO
- DrugPlacebo Administration
Given SC
- OtherQuality-of-Life Assessment
Locations (6)
- University of MiamiMiami, Florida
- Weill Cornell Medical CollegeNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Vanderbilt University Medical CenterNashville, Tennessee
- UT Southwestern Medical Center at DallasDallas, Texas