SHS_492228 MILM CCLG 13084
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Oral Azacitidine plus Best supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission
This is an international, multicenter, placebo-controlled, phase 3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplastic Syndromes (MDS).
1.Male or female subjects ≥ 55 years of age
2.Newly diagnosed, confirmed de novo AML or AML Secondary to prior MDS
3.First CR/CRi with induction therapy ± consolidation therapy within 90 days of achieving CR
4.Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3
1.AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
2.Prior bone marrow or stem cell transplantation
3.Candidate for allogeneic bone marrow or stem cell transplant
4.Have achieved CR/CRi following therapy with hypomethylating agents
5.Diagnosis of malignant disease within the previous 12 months
6.Proven Central Nervous System (CNS) leukemia
Michael Milder, M.D.