Trial Identifiers
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Scientific Title
A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Commercial Sponsor
Novartis Pharmaceuticals
Summary
This is a randomised trial with experimental and placebo comparator arms. Participants in the Experimental Arm will receive MBG453 plus Azacitidine. A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W).A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9. Participants in the Placebo Comparator Arm will receive a placebo plus Azacitidine. A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W). A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9.