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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Specified dose on specified days
Specified dose of specified days
Local Institution - 0011
Huntsville, Alabama, United States
Local Institution - 0017
Nagoya, Aichi-ken, Japan
Local Institution - 0023
Nagoya, Aichi-ken, Japan
Local Institution - 0009
Toyoake, Aichi-ken, Japan
Local Institution - 0022
Aomori, Aomori, Japan
Local Institution - 0005
Kamogawa, Chiba, Japan
Local Institution - 0003
Kashiwa-shi, Chiba, Japan
Local Institution - 0010
Matsuyama, Ehime, Japan
Local Institution - 0020
Yoshida Gun, Fukui, Japan
Local Institution - 0016
Fukuoka, Fukuoka, Japan
...and 21 more locations
Recurrence Free Survival (RFS)
The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment.
Time frame: Approximately 17.7 months
Overall Survival (OS)
The time from randomization to death from any cause and will be calculated using the randomization date and date of death, or date of last follow-up for censored participants. All participants will be followed until dropout, death, or study termination. Participants who dropout or are alive at study termination will have their OS times censored at the time of last contact, as appropriate.
Time frame: Approximately 17.7 months
Time to Relapse From CR or CRi
The interval from the date of randomization to the date of documented relapse after CR or CRi, as defined according to the IWG AML response criteria. Time to relapse will be analyzed using a competing risk analysis where death without documented relapse is treated as a competing risk for relapse from CR/CRi. Similar censoring rules as in primary analysis of RFS will be applied.
Time frame: Approximately 17.7 months
Time to Discontinuation
The interval from the date of randomization to the date of discontinuation from IP. Subjects who are ongoing in treatment at the time of study closure will be censored at the date of last visit.
Time frame: Approximately 17.7 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Approximately 17.7 months
Number of Participants With Clinically Significant Changes in Physical Examination
Number of participants with clinically significant changes in physical examination
Time frame: Approximately 17.7 months
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs include the following: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, temperature and weight.
Time frame: Approximately 17.7 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Examinations
Time frame: Approximately 17.7 months
Number of Participants Who Received Concomitant Medication
Concomitant medications are defined as non-study medications that are started after the date of randomization but before the end of the study treatment period or started on or before the date of randomization but ended or remain ongoing during the study treatment period.
Time frame: Approximately 17.7 months
Mean Change From Baseline in Facit-Fatigue Scale
The FACIT-Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during usual daily activities over the past week. The level of fatigue is measured on a five-point Likert scale (0 = not at all fatigued to 4 = very much fatigued). It has scores that range from 0 to 52, with higher scores indicating less fatigue. Quality of life (QoL)scores on these FACIT scales significantly decline as patient performance status worsens.
Time frame: From C1D1 to C12D1 (approximately 336 days)
Mean Change From Baseline in EQ-5D-5L
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. The lower the score the better.
Time frame: From C1D1 to C12D1 (approximately 336 days)
Pharmacokinetic Evaluation: CMax
Cmax is defined as maximum plasma concentration of the drug.
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: Tmax
Tmax is defined is the time to maximum plasma concentration
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: AUC(0-T)
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: AUC(INF)
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: T-Half
the time required for the amount or concentration of a drug to decrease by one-half
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: CLT/F(INF)
the volume of plasma from which a substance is completely removed per unit time.
Time frame: on C1D1 (after first dose on day 1)
Pharmacokinetic Evaluation: Vz/F
the amount of drug in the body to the concentration of drug measured in a biological fluid
Time frame: on C1D1 (after first dose on day 1)
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