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Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

2017年8月25日 更新者：Celgene

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

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

488

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
      • Beijing、中国、100083
        • The Third Hospital of Peking University
      • Jiangsu、中国、210029
        • Peoples Hospital of Jiangsu Province
      • Shanghai、中国、200025
        • Shanghai Ruijin Hospital
      • Shanghai、中国、200433
        • Shanghai Changhai Hospital,the Second Military Medical University
      • Sichuan、中国、610041
        • West China Hospital,Sichuan University
      • Tianjin、中国、3000200
        • Tianjin Blood Disease Hospital
  • 以色列
      • Beer Yaakov、以色列、70300
        • Assaf Harofeh Medical Centre
      • Jerusalem、以色列、91120
        • Hadassah Medical Center
      • Jerusalem、以色列、91031
        • Shaare Zedek Medical Center
      • Petach Tikva、以色列、49100
        • Rabin Medical Center
      • Tel Aviv、以色列、64239
        • Sourasky Medical Center
      • Tel Hashomer、以色列、52621
        • Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
    • Beersheva
      • Beer Sheva、Beersheva、以色列、84101
        • Soroka Medical Center
  • 俄罗斯联邦
      • Ekaterinburg、俄罗斯联邦、620137
        • Central city hospital # 7
      • Moscow、俄罗斯联邦、125284
        • City Clinical Hospital n.a. S. P. Botkin
      • Nizhniy Novgorod、俄罗斯联邦、603126
        • State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
      • Saint Petersburg、俄罗斯联邦、197089
        • Saint Petersburg State Academician I.P. Pavlov Medical University
      • Saratov、俄罗斯联邦、410 028
        • Saratov State Medical University
  • 加拿大
      • Calgary、加拿大、T2N 2T9
        • Tom Baker Cancer Centre
      • Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 0V9
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • Ottawa、Ontario、加拿大、K1H8L6
        • Ottawa Hospital General Campus
      • Toronto、Ontario、加拿大、M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • Hopital Maisonneuve-Rosemont
      • Montreal、Quebec、加拿大、H4J 1C5
        • Hopital Du Sacre Coeur de Montreal
      • Montreal、Quebec、加拿大、H2L 4M1
        • Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
  • 台湾
      • Taipei、台湾、10002
        • National Taiwan University Hospital
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital Pei-Tou District
    • Kaohsiung
      • Niao-Sung Hsiang、Kaohsiung、台湾、83301
        • Chang Gung Memorial Hospital, Kaohsiung
  • 大韩民国
      • Daegu、大韩民国、700-721
        • Kyungpook National University Hospital
      • Seoul、大韩民国、138-736
        • Asan Medical Center
      • Seoul、大韩民国、152-703
        • Korea University Hospital at Guro
      • Seoul、大韩民国、137-701
        • Seoul Saint Mary's Hospital Seocho-gu
    • Seoul
      • Gangnam-gu、Seoul、大韩民国、135-710
        • Samsung Medical Center
      • Jongno-gu、Seoul、大韩民国、110-774
        • Seoul National University Hospital
      • Seodaemun-gu、Seoul、大韩民国、120-752
        • Yonsei University Health System
  • 奥地利
      • Salzburg、奥地利、5020
        • Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
    • Upper Austria
      • Wels、Upper Austria、奥地利、4600
        • Klinikum Wels-Grieskirchen GmbH
    • Vienna
      • Wien、Vienna、奥地利、1160
        • Wilhelminenspital, I Medizinische Abt.
  • 德国
    • Baden-wuerttemberg
      • Heidelberg、Baden-wuerttemberg、德国、69120
        • Universitatsklinikum Heidelberg
      • Ulm、Baden-wuerttemberg、德国、89081
        • Universitätsklinikum Ulm
    • Mecklenburg-vorpommern
      • Rostock、Mecklenburg-vorpommern、德国、18057
        • University of Rostock, Div. of Haematology and Oncology
    • Nordrhein-Westfallen
      • Essen、Nordrhein-Westfallen、德国、45122
        • Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
    • Nordrhein-westfalen
      • Düesseldorf、Nordrhein-westfalen、德国、40211
        • Heinrich-Heine-Universität Düsseldorf
    • Sachsen
      • Leipzig、Sachsen、德国、04103
        • Universitatsklinikum Leipzig
    • Thueringen
      • Jena、Thueringen、德国、07747
        • Universitatsklinikum Jena
  • 意大利
      • Alessandria、意大利、15121
        • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
      • Ancona、意大利、60126
        • Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
      • Bari、意大利、70124
        • Azienda Ospedaliera Policlinico Di Bari
      • Bologna、意大利、40138
        • Azienda Ospedaliera Sant'Orsola Malpighi
      • Firenze、意大利、50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Reggio Calabria、意大利、89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli
      • Roma、意大利、00168
        • Policlinico Universitario Agostino Gemelli
      • Roma、意大利、00161
        • Azienda Policlinico Umberto I di Roma
      • Udine、意大利、33100
        • Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
      • Varese、意大利、21100
        • Ospedale di Circolo e Fondazione Macchi
    • Potenza
      • Rionero in Vulture、Potenza、意大利、85028
        • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
    • Turin
      • Orbassano、Turin、意大利、10043
        • Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
  • 捷克语
    • Jihormoravsky Kraj
      • Brno、Jihormoravsky Kraj、捷克语、625 00
        • Fakultni nemocnice Brno
    • Olomoucký Kraj
      • Olomouc、Olomoucký Kraj、捷克语、775 20
        • Fakultni nemocnice Olomouc, Hemato-onkologicka klinika
    • Praha
      • Praha 2、Praha、捷克语、128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 2、Praha、捷克语、128 20
        • Ustav hematologie a krevni transfuze
  • 比利时
      • La Louvière、比利时、7100
        • Centre Hospitalier de Jolimont-Lobbes
    • Hainaut
      • Charleroi、Hainaut、比利时、6000
        • Grand Hôpital de Charleroi
    • Namur
      • Yvoir、Namur、比利时、5530
        • Cliniques Universitaires UCL de Mont-Godinne
    • Oost-vlaanderen
      • Ghent、Oost-vlaanderen、比利时、9000
        • Universitair Ziekenhuis Gent
    • West-vlaanderen
      • Brugge、West-vlaanderen、比利时、8000
        • Algemeen Ziekenhuis Sint-Jan
  • 法国
      • Aquitaine、法国、64109
        • Centre Hospitalier de la Côte Basque
      • Lyon Cedex 03、法国、69437
        • Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
    • Alsace
      • Strasbourg、Alsace、法国、67091
        • Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
    • ILE-DE-France
      • Bobigny、ILE-DE-France、法国、93009
        • Hospital Avicenne, Service d'hematologie Clinique
    • Ile-de-france
      • Clamart Cedex、Ile-de-france、法国、92141
        • Hopital Percy Clamart
      • Paris Cedex 10、Ile-de-france、法国、75475
        • Hopital Saint Louis
    • Limousin Lorraine
      • Limoges、Limousin Lorraine、法国、87042
        • Centre Hopitalier Universitaire Dupuytren
    • Midi-pyrénées
      • Toulouse Cedex 09、Midi-pyrénées、法国、31059
        • Centre Hospitalier Universitaire de Toulouse
    • Nice
      • Nice Cedex 3、Nice、法国、06202
        • Centre Hospitalier Universitaire De Nice
    • Pays de La Loire
      • Angers cedex 09、Pays de La Loire、法国、49933
        • CHRU d'Angers
      • Nantes Cedex 1、Pays de La Loire、法国、44093
        • Centre Hospitalier Universitaire Nantes, Hotel Dieu
    • Picardie
      • Amiens Cedex 1、Picardie、法国、80054
        • Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
    • Provence Alpes Cote D'azur
      • Marseille、Provence Alpes Cote D'azur、法国、13385
        • Hopital de la Conception
  • 波兰
    • Dolnoslaskie
      • Wroclaw、Dolnoslaskie、波兰、50-367
        • Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
      • Wroclaw、Dolnoslaskie、波兰、53-439
        • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
    • Lodzkie
      • Lódz、Lodzkie、波兰、93-510
        • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
    • Mazowieckie
      • Warszawa、Mazowieckie、波兰、02-776
        • Instytut Hematologii i Transfuzjologii
    • Slaskie
      • Katowice、Slaskie、波兰、40-032
        • Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • 澳大利亚
      • Fitzroy、澳大利亚、3065
        • St Vincent's Hospital
    • New South Wales
      • Randwick、New South Wales、澳大利亚、2031
        • Prince of Wales Hospital
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3002
        • Peter MacCallum Cancer Centre
      • Footscray、Victoria、澳大利亚、3011
        • Western Hospital
      • Melbourne、Victoria、澳大利亚、3050
        • Royal Melbourne Hospital
  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Massachusetts General Hospital
    • Texas
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
  • 英国
      • Bournemouth、英国、BH7 7DW
        • Royal Bournemouth Hospital
      • London、英国、SE5 9RS
        • King's College Hospital
      • London、英国、EC1A 7BE
        • Barts and the London NHS Trust
      • Manchester、英国、M13 9WL
        • Manchester Royal Infirmary
      • Oxford、英国、OX3 9DS
        • Churchill Hospital
      • Wolverhampton、英国、WV10 0QP
        • New Cross Hospital
    • Surrey
      • Sutton、Surrey、英国、SM2 5PT
        • Royal Marsden Hospital
  • 荷兰
      • Groningen、荷兰、9700 RB
        • Universitair Medisch Centrum Groningen
  • 西班牙
      • Barcelona、西班牙、08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid、西班牙、28009
        • Hospital General Universitario Gregorio Marañón
      • Salamanca、西班牙、37007
        • Hospital Universitario De Salamanca
      • Sevilla、西班牙、41013
        • Hospital Universitario Virgen del Rocío
      • Valencia、西班牙、46009
        • Hospital Universitario La Fe
    • Asturias
      • Oviedo、Asturias、西班牙、33006
        • Hospital Central de Asturias
    • Baleares
      • Palma de Mallorca、Baleares、西班牙、07198
        • Hospital Son Llatzer
      • Palma de Mallorca、Baleares、西班牙、07014
        • Hospital Son Dureta

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Azacitidine
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
药品：Azacitidine
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
其他名称：
  • 维达扎
有源比较器：Conventional Care Regimen
药品：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Kaplan-Meier Estimates for Overall Survival
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months

次要结果测量

结果测量
措施说明
大体时间
One-year Overall Survival Rate
大体时间：From Day 1 (randomization) to 40 months
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.
From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
大体时间：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
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.
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)
大体时间：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
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.
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)
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
大体时间：Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
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.
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.
大体时间：Day 1 (randomization) to 40 months
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
Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
大体时间：Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
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
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
大体时间：Baseline to Cycle 3; at approximately 3 months
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).
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
大体时间：Baseline to Cycle 5, at approximately 5 months
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).
Baseline to Cycle 5, at approximately 5 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
大体时间：Baseline to Cycle 7, at approximately 7 months
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).
Baseline to Cycle 7, at approximately 7 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
大体时间：Baseline to Cycle 9, at approximately 9 months
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).
Baseline to Cycle 9, at approximately 9 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
大体时间：Baseline to End of Study; at approximately 11-12 months
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).
Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
大体时间：Baseline to Cycle 3, at approximately 3 months
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).
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
大体时间：Baseline to Cycle 5, at approximately 5 months
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).
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
大体时间：Baseline to Cycle 7, at approximately 7 months
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).
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
大体时间：Baseline to Cycle 9, at approximately 9 months
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).
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
大体时间：Baseline to end of study, at approximately 11-12 months
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).
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
大体时间：Baseline to Cycle 3, at approximately 3 months
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.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
大体时间：Baseline to Cycle 5, at approximately 5 months
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.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
大体时间：Baseline to Cycle 7, at approximately 7 months
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.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
大体时间：Baseline to Cycle 9, at approximately 9 months
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.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
大体时间：Baseline to end of study, at approximately 11-12 months
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.
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
大体时间：Baseline to Cycle 3, at approximately 3 months
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.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
大体时间：Baseline to Cycle 5, at approximately 5 months
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.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
大体时间：Baseline to Cycle 7, at approximately 7 months
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.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
大体时间：Baseline to Cycle 9, at approximately 9 months
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.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
大体时间：Baseline to end of study, at approximately 11-12 months
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.
Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
大体时间：Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
大体时间：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
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
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

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Celgene

调查人员

  • 研究主任：C L Beach, PharmD、Celgene Corporation

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年6月1日

初级完成 (实际的)

2014年1月22日

研究完成 (实际的)

2016年7月25日

研究注册日期

首次提交

2010年2月16日

首先提交符合 QC 标准的

2010年2月22日

首次发布 (估计)

2010年2月24日

研究记录更新

最后更新发布 (实际的)

2017年8月29日

上次提交的符合 QC 标准的更新

2017年8月25日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AZA-AML-001

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研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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