Clinical Trials

Inclusion Criteria:

• Morphologically confirmed diagnosis of MDS/CMMoL according to FAB or WHO classification, including RAEB-t and MDS/MPN
• International prognostic score-revised (IPSS-R) of >3.5 (Intermediate, High or Very High)
• Previously untreated with hypomethylating agents for MDS/CMMoL
• Performance status of 0, 1 or 2 by the ECOG scale
• Adequate renal and liver function
• Female subjects of childbearing potential must have a negative serum pregnancy test at screening within 96 hours prior to the first study dose.
• Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined by the investigator, for example, those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly during the study and for a period of 3 months following the last dose of any drug administered during the study.

Exclusion Criteria:

• Relapsed or refractory to hypomethylating agents
• Acute myeloid leukemia (AML), except those patients with RAEB-t who are not candidates for intensive AML therapy.
• Participated in any interventional study within 4 weeks of randomization or 5 half lives (whichever is longer).
• Received any hematopoietic growth factors within 14 days prior to screening.
• Prior malignancy or secondary malignancy within the prior 2 years (except in situ cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin).
• known diagnosis of human immunodeficiency virus or chronic active Hep B or C.
• Uncontrolled hypertension
• Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
• Lack of recovery of prior adverse events to Grade ≤1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
• Nursing or pregnant.
• Known allergy or hypersensitivity to any of the formulation components
• Any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.
• History of cranial nerve palsy.
• Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy within 5 half-lives of randomization.