An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

• CC-486 (Drug), also known as Azacitidine, Onureg: Specified dose on specified days
• Placebo (Other): Specified dose on specified days

Primary outcomes

• Relapse-free survival (RFS) [Up to 30 months]

Secondary outcomes

• Overall Survival (OS) [Up to approximately 42 months]
• Time to relapse [Up to approximately 30 months]
• Time to discontinuation of treatment [Up to approximately 42 months]
• Number of participants with adverse events (AEs) [Up to approximately 42 months]
• Number of participants with physical examination abnormalities [Up to approximately 42 months]
• Number of participants with vital sign abnormalities [Up to approximately 42 months]
• Number of participants with clinical laboratory abnormalities [Up to approximately 42 months]
• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t)) [Up to 8 weeks]
• Maximum observed plasma concentration (Cmax) [Up to 8 weeks]
• Time of maximum observed concentration (Tmax) [Up to 8 weeks]
• Terminal elimination half-life (T1/2) [Up to 8 weeks]
• Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes [Up to approximately 30 months]
• Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [Up to approximately 30 months]
• EQ-5D-5L scale [Up to approximately 30 months]
• Visual analog scale (VAS) [Up to approximately 30 months]
• Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year [Up to approximately 30 months]: HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
• Healthcare Resource Utilization (HRU): Number of Medications [Up to approximately 30 months]: HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
• Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year [Up to approximately 30 months]: HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
• Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year [Up to approximately 30 months]: HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
• Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year [Up to approximately 30 months]: HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.

Sex: All, ages: 55 Years to any

Inclusion Criteria:

* Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)
* Eastern cooperative oncology group performance status of 0, 1, or 2
* Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy
* Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy

Exclusion Criteria:

* Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia
* Candidate for allogeneic bone marrow or stem cell transplant at screening
* Have achieved CR/CRi following therapy with hypomethylating agents
* AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
* Proven central nervous system leukemia
* Prior bone marrow or stem cell transplantation

Other protocol-defined inclusion/exclusion criteria apply

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb