A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Oral Azacitidine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 55 years of age inclusive at the time of signing the informed consent Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy Exclusion Criteria: Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML Prior bone marrow or stem cell transplantation Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents Have achieved CR/CRi following therapy with hypomethylating agents Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Azacitidine<br> | Drug: Oral Azacitidine<br>* Specified dose on specified days<br>* Other names: Onureg;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose of specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free Survival (RFS) |  | Up to 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 27 months | 
| Time to relapse from Complete Remission (CR) |  | Up to 27 months | 
| Time to relapse from complete remission with incomplete blood count recovery (CRi) |  | Up to 27 months | 
| Time to discontinuation from treatment |  | Up to 27 months | 
| Number of participants with Adverse Events |  | Up to 50 months | 
| Number of participants with physical examination abnormalities |  | Up to 50 months | 
| Number of participants with vital sign abnormalities |  | Up to 50 months | 
| Number of participants with clinical laboratory abnormalities |  | Up to 50 months | 
| Maximum observed plasma concentration (Cmax) |  | Up to 27 months | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 27 months | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |  | Up to 27 months | 
| Area under the serum concentration-time curve from time 0 to infinity AUC(INF) |  | Up to 27 months | 
| Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale |  | Up to 27 months | 
| Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) |  | Up to 27 months |