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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Relapse-free survival (RFS)
Time frame: Up to 30 months
Overall Survival (OS)
Time frame: Up to approximately 42 months
Time to relapse
Time frame: Up to approximately 30 months
Time to discontinuation of treatment
Time frame: Up to approximately 42 months
Number of participants with adverse events (AEs)
Time frame: Up to approximately 42 months
Number of participants with physical examination abnormalities
Time frame: Up to approximately 42 months
Number of participants with vital sign abnormalities
Time frame: Up to approximately 42 months
Number of participants with clinical laboratory abnormalities
Time frame: 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))
Time frame: Up to 8 weeks
Maximum observed plasma concentration (Cmax)
Time frame: Up to 8 weeks
Time of maximum observed concentration (Tmax)
Time frame: Up to 8 weeks
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Local Institution - 0031
Hefei, Anhui, China
Local Institution - 0013
Beijing, BJ, China
Local Institution - 0027
Beijing, BJ, China
Local Institution - 0028
Chongqing, CQ, China
Local Institution - 0003
Guangzhou, GD, China
Local Institution - 0008
Guangzhou, GD, China
Local Institution - 0010
Shenzhen, GD, China
Local Institution - 0002
Shijiazhuang, HE, China
Local Institution - 0022
Xuzhou, Jiangsu, China
Local Institution - 0005
Shenyang, Liaoning, China
...and 24 more locations
Terminal elimination half-life (T1/2)
Time frame: Up to 8 weeks
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Time frame: Up to approximately 30 months
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: Up to approximately 30 months
EQ-5D-5L scale
Time frame: Up to approximately 30 months
Visual analog scale (VAS)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 30 months