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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01074047
Registration number
NCT01074047
Ethics application status
Date submitted
16/02/2010
Date registered
24/02/2010
Date last updated
29/08/2017
Titles & IDs
Public title
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
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Scientific title
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
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Secondary ID [1]
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AZA-AML-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Conventional Care Regimen
Experimental: Azacitidine - Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Active Comparator: Conventional Care Regimen - Conventional Care Regimen
Treatment: Drugs: Azacitidine
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Treatment: Drugs: Conventional Care Regimen
Physician pre-selects prior to randomization from one of the following:
Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
Best Supportive Care only; until study end
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan-Meier Estimates for Overall Survival
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Assessment method [1]
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Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
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Timepoint [1]
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Day 1 (randomization) to 40 months
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Secondary outcome [1]
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One-year Overall Survival Rate
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Assessment method [1]
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Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
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Timepoint [1]
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From Day 1 (randomization) to 40 months
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Secondary outcome [2]
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Event-free Survival (EFS)
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Assessment method [2]
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Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.
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Timepoint [2]
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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
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Secondary outcome [3]
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Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
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Assessment method [3]
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Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.
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Timepoint [3]
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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
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Secondary outcome [4]
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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)
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Assessment method [4]
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A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of = 1 x 10^9/L, a platelet count = 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.
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Timepoint [4]
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Day 1 (randomization) to 40 months
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Secondary outcome [5]
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Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
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Assessment method [5]
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The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.
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Timepoint [5]
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Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
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Secondary outcome [6]
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Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
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Assessment method [6]
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The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on = 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
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Timepoint [6]
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Day 1 (randomization) to 40 months
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Secondary outcome [7]
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Number of Participants With Adverse Events (AEs)
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Assessment method [7]
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AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
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Timepoint [7]
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Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
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Secondary outcome [8]
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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
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Assessment method [8]
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
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Timepoint [8]
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Baseline to Cycle 3; at approximately 3 months
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Secondary outcome [9]
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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
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Assessment method [9]
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
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Timepoint [9]
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Baseline to Cycle 5, at approximately 5 months
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Secondary outcome [10]
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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
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Assessment method [10]
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0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
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Timepoint [10]
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Baseline to Cycle 7, at approximately 7 months
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Secondary outcome [11]
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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
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Assessment method [11]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
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Timepoint [11]
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Baseline to Cycle 9, at approximately 9 months
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Secondary outcome [12]
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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
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Assessment method [12]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
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Timepoint [12]
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Baseline to End of Study; at approximately 11-12 months
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Secondary outcome [13]
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HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
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Assessment method [13]
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0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
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Timepoint [13]
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Baseline to Cycle 3, at approximately 3 months
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Secondary outcome [14]
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HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
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Assessment method [14]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
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Timepoint [14]
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Baseline to Cycle 5, at approximately 5 months
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Secondary outcome [15]
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HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
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Assessment method [15]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
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Timepoint [15]
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Baseline to Cycle 7, at approximately 7 months
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Secondary outcome [16]
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HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
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Assessment method [16]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
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Timepoint [16]
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Baseline to Cycle 9, at approximately 9 months
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Secondary outcome [17]
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0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
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Assessment method [17]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
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Timepoint [17]
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Baseline to end of study, at approximately 11-12 months
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Secondary outcome [18]
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HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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Assessment method [18]
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0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Timepoint [18]
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Baseline to Cycle 3, at approximately 3 months
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Secondary outcome [19]
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0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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Assessment method [19]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Timepoint [19]
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0
Baseline to Cycle 5, at approximately 5 months
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Secondary outcome [20]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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Assessment method [20]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Timepoint [20]
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0
Baseline to Cycle 7, at approximately 7 months
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Secondary outcome [21]
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0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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Assessment method [21]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Timepoint [21]
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0
Baseline to Cycle 9, at approximately 9 months
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Secondary outcome [22]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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Assessment method [22]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Timepoint [22]
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0
Baseline to end of study, at approximately 11-12 months
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Secondary outcome [23]
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0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
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Assessment method [23]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
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Timepoint [23]
0
0
Baseline to Cycle 3, at approximately 3 months
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Secondary outcome [24]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
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Assessment method [24]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Query!
Timepoint [24]
0
0
Baseline to Cycle 5, at approximately 5 months
Query!
Secondary outcome [25]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
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Assessment method [25]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Query!
Timepoint [25]
0
0
Baseline to Cycle 7, at approximately 7 months
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Secondary outcome [26]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Query!
Assessment method [26]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Query!
Timepoint [26]
0
0
Baseline to Cycle 9, at approximately 9 months
Query!
Secondary outcome [27]
0
0
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Query!
Assessment method [27]
0
0
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Query!
Timepoint [27]
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0
Baseline to end of study, at approximately 11-12 months
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Secondary outcome [28]
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0
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
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Assessment method [28]
0
0
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Query!
Timepoint [28]
0
0
Day 1 (randomization) to 40 months
Query!
Secondary outcome [29]
0
0
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
Query!
Assessment method [29]
0
0
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Query!
Timepoint [29]
0
0
Day 1 (randomization) to 40 months
Query!
Secondary outcome [30]
0
0
HRU: Number of Participants Receiving Transfusions
Query!
Assessment method [30]
0
0
Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Query!
Timepoint [30]
0
0
Day 1 (randomization) to 40 months
Query!
Secondary outcome [31]
0
0
HRU: Rate of Transfusions Per Patient Year
Query!
Assessment method [31]
0
0
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Query!
Timepoint [31]
0
0
Day 1 (randomization) to 40 months
Query!
Secondary outcome [32]
0
0
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [32]
0
0
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Query!
Timepoint [32]
0
0
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
Query!
Eligibility
Key inclusion criteria
- Diagnosis of one of the following
- Newly diagnosed de novo acute myeloid leukemia (AML)
- AML secondary to myelodysplastic syndromes (MDS)
- AML secondary to exposure to leukemogenic therapy or agents with primary
malignancy in remission for at least 2 years
- Bone marrow blasts >30%
- Age = 65 years
- Easter Cooperative Oncology Group (ECOG) 0-2
Query!
Minimum age
65
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
- Previous treatment with azacitidine, decitabine or cytarabine
- Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
- AML French American British subtype (FAB M3)
- AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
- Prior bone marrow or stem cell transplantation
- Candidate for allogeneic bone marrow or stem cell transplant
- Diagnosis of malignant disease within the previous 12 months (excluding base cell
carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy
excised or irradiated with a high probability of cure)
- Malignant hepatic tumors
- Uncontrolled systemic infection
- Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or
C
- Use of any experimental drug or therapy within 28 days prior to Day 1
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/07/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
488
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [2]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [3]
0
0
Peter MacCallum Cancer Centre - East Melbourne
Query!
Recruitment hospital [4]
0
0
Western Hospital - Footscray
Query!
Recruitment hospital [5]
0
0
Royal Melbourne Hospital - Melbourne
Query!
Recruitment hospital [6]
0
0
St Vincent's Hospital - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [4]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [5]
0
0
3050 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Massachusetts
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Texas
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Upper Austria
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Vienna
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Salzburg
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Hainaut
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Namur
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Oost-vlaanderen
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
West-vlaanderen
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
La Louvière
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Alberta
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Manitoba
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Nova Scotia
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Quebec
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Calgary
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Beijing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Jiangsu
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Shanghai
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Sichuan
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Tianjin
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Jihormoravsky Kraj
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Olomoucký Kraj
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Praha
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Alsace
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
ILE-DE-France
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Ile-de-france
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Limousin Lorraine
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Midi-pyrénées
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Nice
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Pays de La Loire
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Picardie
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Provence Alpes Cote D'azur
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Aquitaine
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Lyon Cedex 03
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Baden-wuerttemberg
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Mecklenburg-vorpommern
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Nordrhein-westfalen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Nordrhein-Westfallen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Sachsen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Thueringen
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Beersheva
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Beer Yaakov
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Jerusalem
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Petach Tikva
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Tel Aviv
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Tel Hashomer
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Potenza
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Turin
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Alessandria
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Ancona
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Bari
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Bologna
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Firenze
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Reggio Calabria
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Roma
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Udine
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Varese
Query!
Country [59]
0
0
Korea, Republic of
Query!
State/province [59]
0
0
Seoul
Query!
Country [60]
0
0
Korea, Republic of
Query!
State/province [60]
0
0
Daegu
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Groningen
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Dolnoslaskie
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Lodzkie
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Mazowieckie
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Slaskie
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Ekaterinburg
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Moscow
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Nizhniy Novgorod
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Saint Petersburg
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Saratov
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Asturias
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Baleares
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Barcelona
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Madrid
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Salamanca
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Sevilla
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Valencia
Query!
Country [78]
0
0
Taiwan
Query!
State/province [78]
0
0
Kaohsiung
Query!
Country [79]
0
0
Taiwan
Query!
State/province [79]
0
0
Taipei
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Surrey
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Bournemouth
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
London
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
Manchester
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Oxford
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Celgene
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional
care regimens on overall survival in elderly AML patients.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01074047
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
C L Beach, PharmD
Query!
Address
0
0
Celgene Corporation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01074047
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