Canakinumab and Anacitidine for the Treatment of Low or Intermediate Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

Summary

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PRIMARY OBJECTIVE: I. To assess the clinical activity of canakinumab in patients with low or intermediate-1 myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). SECONDARY OBJECTIVES: I. To study the safety profile of canakinumab in patients with low or intermediate-1 MDS or CMML...

PRIMARY OBJECTIVE: I. To assess the clinical activity of canakinumab in patients with low or intermediate-1 myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). SECONDARY OBJECTIVES: I. To study the safety profile of canakinumab in patients with low or intermediate-1 MDS or CMML. II. Rate of transfusion independence. III. Duration of response. IV. Progression-free survival (PFS), leukemia-free survival (LFS) and overall survival (OS). EXPLORATORY OBJECTIVE: I. Correlative studies (pharmacodynamic [PD] parameters of canakinumab). OUTLINE: Patients receive canakinumab subcutaneously (SC) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

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