Phase II Study of Canakinumab Injection for Adults with Low or Intermediate-1 Risk Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

What this Trial Is About

Researchers are evaluating canakinumab, a monoclonal antibody, for treating patients with low or intermediate-1 risk myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML. The study is a phase II trial focusing on patients with these blood disorders to assess the drugs clinical activity, safety, and effects on transfusion independence and response duration. Participants receive canakinumab through a subcutaneous injection on the first day of each 28-day cycle. Treatment continues in repeated cycles unless there is disease progression or unacceptable side effects. After completing treatment, patients will be followed up at 30 days and then every six months to monitor their health. Throughout the trial, researchers will assess hematological improvement after two cycles, monitor adverse events for four weeks, and evaluate longer-term outcomes such as transfusion independence, duration of response, progression-free survival, leukemia-free survival, and overall survival for up to two years. Participants will undergo regular assessments and safety monitoring during the study period, which lasts until disease progression or unacceptable toxicity occurs.

A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia