A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

简要总结

主要结局

次要结局

• One-year Overall Survival Rate(From Day 1 (randomization) to 40 months)
• Event-free Survival (EFS)(Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months)
• Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)(Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months)
• Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)(Day 1 (randomization) to 40 months)
• Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates(Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.)
• Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.(Day 1 (randomization) to 40 months)
• Number of Participants With Adverse Events (AEs)(Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017)
• Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain(Baseline to Cycle 3; at approximately 3 months)
• Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain(Baseline to End of Study; at approximately 11-12 months)
• HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea(Baseline to end of study, at approximately 11-12 months)
• HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain(Baseline to end of study, at approximately 11-12 months)
• HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain(Baseline to end of study, at approximately 11-12 months)
• Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations(Day 1 (randomization) to 40 months)
• Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year(Day 1 (randomization) to 40 months)
• HRU: Number of Participants Receiving Transfusions(Day 1 (randomization) to 40 months)
• HRU: Rate of Transfusions Per Patient Year(Day 1 (randomization) to 40 months)
• Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)(From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days)