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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission

Conditions
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Leukemia, Myeloid, Acute

Intervention / Treatment
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* Drug: CC-486
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-486/Oral Azacitidine Administration<br> | Drug: CC-486<br>* Specified dose on specified days<br>* Other names: Onureg;|
| Placebo Comparator: Placebo Administration<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival (RFS) |  | Up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to approximately 30 months | 
| Healthcare Resource Utilization (HRU): Number of Medications | 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. | Up to approximately 30 months | 
| Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year | 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. | Up to approximately 30 months | 
| Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year | 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. | Up to approximately 30 months | 
| Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year | 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. | Up to approximately 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia