Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

This is an international, multicenter, placebo-controlled, phase3 study with a double-blind,
randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary
to prior diagnosis of Myelodysplasic Syndromes (MDS) or chronic myelomonocytic leukemia
(CMML)

Inclusion Criteria:

1. Male or female subjects ≥ 55 years of age

2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior
myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)

3. First Complete remission (CR)/ Complete remission with incomplete blood count recovery
(CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of
achieving CR or CRi)

4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

Exclusion Criteria:

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. Have achieved CR/CRi following therapy with hypomethylating agents

4. Diagnosis of malignant disease within the previous 12 months

5. Proven Central Nervous System (CNS) leukemia