Clinical Trials

Key Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Patients must have a diagnosis prior to participation in the study of IPSS-R very low, low, or intermediate risk MDS with ≤ 10% bone marrow blasts and one or more of the following:
  • Symptomatic anemia with hemoglobin < 10 g/dL that has relapsed after or is refractory to ESAs (or the patient is intolerant to ESAs);
  • Symptomatic anemia with hemoglobin < 10 g/dL) that is ESA-naive with EPO level ≥ 500 /uL;
  • Thrombocytopenia with platelets < 30,000/uL or with clinically significant bleeding or bruising and platelets < 50,000/uL;
  • Neutropenia with an absolute neutrophil count (ANC) < 500/ µL or with recurrent and/or severe infections and an ANC that is < 1000/ µL and amenable to response assessments by International Working Group (IWG) response criteria in myelodysplasia (Cheson et al 2006).
• Patients who are refractory to, intolerant of, or ineligible/unable to receive SOC therapeutic options including lenalidomide.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions' guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study.

Key Exclusion Criteria:

• Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
• History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
• Patients with chronic myelomonocytic leukemia (CMML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
• Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or ESAs anytime ≤ 2 weeks (or 5 half-lives, whichever is longer) prior to start of study treatment.
• Systemic chronic corticosteroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
• For arms containing canakinumab: Patients with ANC < 500 /µL.