Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Beijing、中国、100032
- Local Institution
-
Beijing、中国、100071
- Local Institution
-
Beijing、中国、100142
- Local Institution
-
Beijing、中国、100853
- Local Institution
-
Santiago、中国、7630370
- Local Institution
-
Shanghai、中国、200030
- Local Institution
-
Shanghai、中国、200433
- Local Institution
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510060
- Local Institution
-
Guanzhou、Guangdong、中国、510080
- Local Institution
-
Shantou、Guangdong、中国、515041
- Local Institution
-
-
Hubei
-
Wuhan、Hubei、中国、430023
- Local Institution
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210002
- Local Institution
-
Nanjing、Jiangsu、中国、210009
- Local Institution
-
Suzhou、Jiangsu、中国、215006
- Local Institution
-
-
Jilin
-
Changchun、Jilin、中国、130012
- Local Institution
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710038
- Local Institution
-
Xi'an、Shaanxi、中国、710061
- Local Institution
-
-
Xinjiang
-
Urumqi、Xinjiang、中国、830011
- Local Institution
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310016
- Local Institution
-
-
-
-
-
Aalborg、丹麦、9000
- Local Institution
-
Herlev、丹麦、2730
- Local Institution
-
Hillerod、丹麦、3400
- Local Institution
-
Naestved、丹麦、4700
- Local Institution
-
Odense、丹麦、5000
- Local Institution
-
-
-
-
-
Beer Sheva、以色列、84101
- Local Institution
-
Haifa、以色列、31096
- Local Institution
-
Jerusalem、以色列、91120
- Local Institution
-
Nahariya、以色列、22100
- Local Institution
-
Petah-Tikva、以色列、49100
- Local Institution
-
Rehovot、以色列、76100
- Local Institution
-
Tel Aviv、以色列、64239
- Local Institution
-
Tel-aviv、以色列、69710
- Local Institution
-
Tel-hashomer、以色列、52621
- Local Institution
-
Zerifin、以色列、70300
- Local Institution
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-
-
-
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Chelyabinsk、俄罗斯联邦、454087
- Local Institution
-
Kazan、俄罗斯联邦、420029
- Local Institution
-
Moscow、俄罗斯联邦、115478
- Local Institution
-
Moscow、俄罗斯联邦、125009
- Local Institution
-
Pyatigorsk、俄罗斯联邦、357502
- Local Institution
-
Saint Petersburg、俄罗斯联邦、197758
- Local Institution
-
St-Peterburg、俄罗斯联邦、198255
- Local Institution
-
St. Petersburg、俄罗斯联邦、197022
- Local Institution
-
Tula、俄罗斯联邦、300053
- Local Institution
-
-
-
-
-
Oshawa、加拿大、L1G 2B9
- Local Institution
-
-
Quebec
-
Montreal、Quebec、加拿大、H2W 1S6
- Local Institution
-
Montreal、Quebec、加拿大、H3T 1E2
- Local Institution
-
Montreal、Quebec、加拿大、H4J 1C5
- Local Institution
-
-
-
-
-
Budapest、匈牙利、1121
- Local Institution
-
Budapest、匈牙利、1125
- Local Institution
-
Deszk、匈牙利、6772
- Local Institution
-
Farkasgyepu、匈牙利、8582
- Local Institution
-
Gyula、匈牙利、5703
- Local Institution
-
Matrahaza、匈牙利、3233
- Local Institution
-
Nyiregyhaza、匈牙利、4400
- Local Institution
-
Pecs、匈牙利、7602
- Local Institution
-
Sopron、匈牙利、9400
- Local Institution
-
Szekesfehervar、匈牙利、8000
- Local Institution
-
Szolnok、匈牙利、5000
- Local Institution
-
-
-
-
-
Cape Town、南非、7925
- Local Institution
-
Durban、南非、4067
- Local Institution
-
-
Gauteng
-
Vereeniging、Gauteng、南非、1939
- Local Institution
-
-
Western CAPE
-
Panorama,cape Town、Western CAPE、南非、7500
- Local Institution
-
-
-
-
-
Changhua City、台湾、500
- Local Institution
-
Chiayi、台湾、61363
- Local Institution
-
Kaohsiung County、台湾、83301
- Local Institution
-
Taichung、台湾、404
- Local Institution
-
Taichung、台湾、407.5
- Local Institution
-
Taipei、台湾、112
- Local Institution
-
Taipei、台湾
- Local Institution
-
Taipei City、台湾、100
- Local Institution
-
-
-
-
Cordoba
-
Monteria、Cordoba、哥伦比亚
- Local Institution
-
-
Risaralda
-
Pereira、Risaralda、哥伦比亚
- Local Institution
-
-
-
-
Distrito Federal
-
Mexico、Distrito Federal、墨西哥、06760
- Local Institution
-
-
Jalisco
-
Zapopan、Jalisco、墨西哥、45170
- Local Institution
-
-
Nuevo LEON
-
Monterrey、Nuevo LEON、墨西哥、64060
- Local Institution
-
-
-
-
-
Busan、大韩民国、602-739
- Local Institution
-
Daegu、大韩民国、700-712
- Local Institution
-
Gyeonggi-do、大韩民国、463-802
- Local Institution
-
Seoul、大韩民国、110-744
- Local Institution
-
Seoul、大韩民国、138-736
- Local Institution
-
Seoul、大韩民国、134-791
- Local Institution
-
Seoul、大韩民国、135-720
- Local Institution
-
Seoul、大韩民国、136-705
- Local Institution
-
Seoul、大韩民国、137-701
- Local Institution
-
Seoul、大韩民国、156-755
- Local Institution
-
Suwon、大韩民国、443-721
- Local Institution
-
-
Chungcheongbuk-do
-
Cheonju-si、Chungcheongbuk-do、大韩民国、361-771
- Local Institution
-
-
Gyeonggi-do
-
Goyang-si、Gyeonggi-do、大韩民国、410-769
- Local Institution
-
Suwon-si、Gyeonggi-do、大韩民国、442-723
- Local Institution
-
-
Kangnam-gu
-
Seoul、Kangnam-gu、大韩民国、135-710
- Local Institution
-
-
Seodaemungu
-
Seoul、Seodaemungu、大韩民国、120-752
- Local Institution
-
-
-
-
-
Graz、奥地利、8036
- Local Institution
-
Linz、奥地利、4020
- Local Institution
-
Salzburg、奥地利、5020
- Local Institution
-
-
-
-
-
Porto Alegre、巴西、90430
- Local Institution
-
Ribeirao Preto、巴西、14015
- Local Institution
-
Rio de Janeiro、巴西、20231-050
- Local Institution
-
Sao Paulo、巴西、01224-010
- Local Institution
-
Sao Paulo、巴西、04039-901
- Local Institution
-
-
Ceara
-
Fortaleza、Ceara、巴西、60160-230
- Local Institution
-
-
Minas Gerais
-
Belo Horizonte、Minas Gerais、巴西、30150-270
- Local Institution
-
-
Parana
-
Curitiba、Parana、巴西、81520-060
- Local Institution
-
-
RIO Grande DO SUL
-
Passo Fundo、RIO Grande DO SUL、巴西、99010260
- Local Institution
-
-
SAO Paulo
-
Barretos、SAO Paulo、巴西、14784
- Local Institution
-
Sao Jose dos Campos、SAO Paulo、巴西、12245
- Local Institution
-
-
-
-
-
Bad Berka、德国、99437
- Local Institution
-
Bochum、德国、44791
- Local Institution
-
Darmstadt、德国、64283
- Local Institution
-
Dresden、德国、01307
- Local Institution
-
Frankfurt Am Main、德国、60590
- Local Institution
-
Gauting、德国、82131
- Local Institution
-
Grosshandsdorf、德国、22927
- Local Institution
-
Hamburg、德国、D-21075
- Local Institution
-
Heidelberg、德国、69126
- Local Institution
-
Kassel、德国、34125
- Local Institution
-
Lubeck、德国、23538
- Local Institution
-
Mainz、德国、55131
- Local Institution
-
Muenchen、德国、81925
- Local Institution
-
Neumunster、德国、24534
- Local Institution
-
Nuernberg、德国、90419
- Local Institution
-
Regensburg、德国、93049
- Local Institution
-
Tuebingen、德国、72076
- Local Institution
-
Ulm、德国、89081
- Local Institution
-
Villingen-Schwenningen、德国、78052
- Local Institution
-
-
-
-
-
Benevento、意大利、82100
- Local Institution
-
Bologna、意大利、40138
- Local Institution
-
Lido Di Camaiore、意大利、55041
- Local Institution
-
Lucca、意大利、55100
- Local Institution
-
Monza、意大利、20052
- Local Institution
-
Padova、意大利、35128
- Local Institution
-
Perugia、意大利、06156
- Local Institution
-
Siena、意大利、53100
- Local Institution
-
Sondrio、意大利、23100
- Local Institution
-
Terni、意大利、05100
- Local Institution
-
Treviglio、意大利、24047
- Local Institution
-
-
-
-
-
Prague 2、捷克语、12808
- Local Institution
-
Praha 5、捷克语、150 06
- Local Institution
-
Praha 8、捷克语、180 81
- Local Institution
-
Pribram V-Zdabor、捷克语、26195
- Local Institution
-
Usti Nad Labem、捷克语、401 13
- Local Institution
-
Znojmo、捷克语、669 02
- Local Institution
-
-
Poruba
-
Ostrava、Poruba、捷克语、70852
- Local Institution
-
-
-
-
-
Singapore、新加坡、308433
- Local Institution
-
-
-
-
-
Akashi, Hyogo、日本、6738558
- Local Institution
-
Fukuoka、日本、8128582
- Local Institution
-
Matsuyama, Ehime、日本、791-0280
- Local Institution
-
Osakasayama-city、日本、5898511
- Local Institution
-
Sapporo Hokkaido、日本、003-080
- Local Institution
-
Sapporo, Hokkaido、日本、0608648
- Local Institution
-
Sendai, Miyagi、日本、980-0873
- Local Institution
-
Takatsuki、日本、569-8686
- Local Institution
-
Tokyo、日本、135-8550
- Local Institution
-
-
Aichi
-
Nagoya、Aichi、日本、4648681
- Local Institution
-
Nagoya-shi、Aichi、日本、4600001
- Local Institution
-
-
Chiba
-
Kashiwa、Chiba、日本、277-8577
- Local Institution
-
-
Ishikawa
-
Kanazawa-shi、Ishikawa、日本、9208641
- Local Institution
-
-
Kanagawa
-
Yokohama-Shi、Kanagawa、日本、2360051
- Local Institution
-
Yokohama-shi、Kanagawa、日本、2408555
- Local Institution
-
-
Miyagi
-
Natori-shi、Miyagi、日本、9811293
- Local Institution
-
Sendai、Miyagi、日本、9808574
- Local Institution
-
-
Okayama
-
Kurashiki-shi、Okayama、日本、7010192
- Local Institution
-
Kurashiki-shi、Okayama、日本、710-8602
- Local Institution
-
-
Osaka
-
Hirakata-shi、Osaka、日本、5731191
- Local Institution
-
Osaka-shi、Osaka、日本、5340021
- Local Institution
-
-
Shizuoka
-
Sunto-gun、Shizuoka、日本、411-8777
- Local Institution
-
-
Tokyo
-
Chuo-ku、Tokyo、日本、104-0045
- Local Institution
-
-
Yamaguchi
-
Ube-shi、Yamaguchi、日本、7550241
- Local Institution
-
-
-
-
Metropolitana
-
Santiago、Metropolitana、智利、7520378
- Local Institution
-
Santiago、Metropolitana、智利、8380455
- Local Institution
-
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Valparaiso
-
Vina Del Mar、Valparaiso、智利、2540364
- Local Institution
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-
-
-
-
Aalst、比利时、9300
- Local Institution
-
Liege、比利时、4000
- Local Institution
-
Sint Niklaas、比利时、9100
- Local Institution
-
Yvoir、比利时、5530
- Local Institution
-
-
-
-
-
Caen Cedex 05、法国、14076
- Local Institution
-
Marseille Cedex 20、法国、13915
- Local Institution
-
Paris、法国、75014
- Local Institution
-
Poitiers、法国、86000
- Local Institution
-
Rennes Cedex 9、法国、35033
- Local Institution
-
Toulouse Cedex 9、法国、31059
- Local Institution
-
Vandoeuvre-les-nancy、法国、54511
- Local Institution
-
-
-
-
-
Elblag、波兰、82-300
- Local Institution
-
Gdansk、波兰、80-952
- Local Institution
-
Gdansk- Zaspa、波兰、80-462
- Local Institution
-
Grudziadz、波兰、86-300
- Local Institution
-
Olsztyn、波兰、10-357
- Local Institution
-
Otwock、波兰、05-400
- Local Institution
-
Poznan、波兰、60 569
- Local Institution
-
Szczecin、波兰、70-891
- Local Institution
-
Torun、波兰、87-100
- Local Institution
-
Warsaw、波兰、02-781
- Local Institution
-
-
-
-
-
Bangkok、泰国、10400
- Local Institution
-
Bangkok、泰国、10700
- Local Institution
-
Bangkok、泰国、10330
- Local Institution
-
Chiang Mai、泰国、50200
- Local Institution
-
Songkhla、泰国、90110
- Local Institution
-
-
Tungpayathai
-
Bangkok、Tungpayathai、泰国、10400
- Local Institution
-
-
-
-
South Australia
-
Bedford Park、South Australia、澳大利亚、5042
- Local Institution
-
-
Victoria
-
Box Hill、Victoria、澳大利亚、3128
- Local Institution
-
Frankston、Victoria、澳大利亚、3199
- Local Institution
-
Heidelberg、Victoria、澳大利亚、3084
- Local Institution
-
Wodonga、Victoria、澳大利亚、3690
- Local Institution
-
-
-
-
-
Dublin、爱尔兰、24
- Local Institution
-
Dublin、爱尔兰、4
- Local Institution
-
Dublin、爱尔兰、8
- Local Institution
-
Galway、爱尔兰
- Local Institution
-
-
-
-
-
Gothenburg、瑞典、413 45
- Local Institution
-
Lund、瑞典、221 85
- Local Institution
-
Stockholm、瑞典、17176
- Local Institution
-
Umea、瑞典、SE-901 85
- Local Institution
-
-
-
-
-
Basel、瑞士、4031
- Local Institution
-
Winterthur、瑞士、8401
- Local Institution
-
-
-
-
-
Arequipa、秘鲁
- Local Institution
-
Cercado、秘鲁
- Local Institution
-
Lima、秘鲁、LIMA 11
- Local Institution
-
-
LA Libertad
-
Trujillo、LA Libertad、秘鲁
- Local Institution
-
-
-
-
-
Bucharest、罗马尼亚、030171
- Local Institution
-
Bucuresti、罗马尼亚、010976
- Local Institution
-
Cluj Napoca、罗马尼亚、400058
- Local Institution
-
Sibiu、罗马尼亚、550245
- Local Institution
-
Suceava、罗马尼亚、720237
- Local Institution
-
Timisoara、罗马尼亚、300239
- Local Institution
-
-
-
-
California
-
San Diego、California、美国、92123
- Sharp Memorial Hospital
-
-
Connecticut
-
West Haven、Connecticut、美国、06516
- VA Connecticut Healthcare System
-
-
Florida
-
Boca Raton、Florida、美国、33486
- Lynn Cancer Institute Center For Hematology-Oncology
-
Jacksonville、Florida、美国、32256
- Integrated Community Oncology Network
-
-
Illinois
-
Chicago、Illinois、美国、60612
- University of Illinois at Chicago Medical Center
-
Quincy、Illinois、美国、62301
- Quincy Medical Group
-
Skokie、Illinois、美国、60076
- Presence Medical Group Hematology Oncology
-
Springfield、Illinois、美国、62794-9678
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis、Indiana、美国、46237
- St. Francis Hospital & Health Centers
-
New Albany、Indiana、美国、47150
- Floyd Memorial Cancer Center of Indiana
-
-
Kentucky
-
Hazard、Kentucky、美国、41701
- Kentucky Cancer Clinic
-
Louisville、Kentucky、美国、40207
- Norton Cancer Institute
-
Mount Sterling、Kentucky、美国、40353
- Montgomery Cancer Center
-
-
Michigan
-
Ypsilanti、Michigan、美国、48197
- St Joseph Mercy Hospital
-
-
Missouri
-
Kansas City、Missouri、美国、64131
- University of Kansas Cancer Center
-
Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756-0001
- Dartmouth-Hitchcock Medical Center
-
-
New York
-
Lake Success、New York、美国、11042
- Clinical Research Alliance, Inc.
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Durham Va Medical Center (111g)
-
Huntersville、North Carolina、美国、28078
- Carolina BioOncology Institute
-
Lexington、North Carolina、美国、27295
- Novant Health Oncology Specialists
-
-
Ohio
-
Canton、Ohio、美国、44718
- Gabrail Cancer Center Research
-
-
Oklahoma
-
Tulsa、Oklahoma、美国、74146
- Oklahoma Oncology And Hematology, Pc Dba
-
-
Oregon
-
Portland、Oregon、美国、97227
- Kaiser Permanente Northwest Region
-
-
Pennsylvania
-
Sayre、Pennsylvania、美国、18840
- Guthrie Medical Group, P.C.
-
-
South Carolina
-
Columbia、South Carolina、美国、29209
- WJB Dorn VA Medical Center
-
Greenville、South Carolina、美国、29615
- Cancer Center Of The Carolinas
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37421
- Associated in Oncology and Hematology
-
Knoxville、Tennessee、美国、37909
- Tennessee Cancer Specialists
-
Knoxville、Tennessee、美国、37916
- Thompson Oncology Group
-
-
Texas
-
Austin、Texas、美国、78745
- Texas Oncology, PA - South Austin Cancer Center
-
-
Virginia
-
Blacksburg、Virginia、美国、24060
- Blue Ridge Cancer Care
-
-
Wisconsin
-
Madison、Wisconsin、美国、53705
- Wisconsin Institutes for Medical Research
-
-
-
-
-
Nottingham、英国、NG51PB
- Local Institution
-
Sheffield、英国、S10 2SJ
- Local Institution
-
-
Angus/forfarshire
-
Dundee、Angus/forfarshire、英国、DD1 9SY
- Local Institution
-
-
Cornwall
-
Truro、Cornwall、英国、TR1 3LJ
- Local Institution
-
-
Hampshire
-
Southampton、Hampshire、英国、SO16 6YD
- Local Institution
-
-
-
-
-
Breda、荷兰、4818 CK
- Local Institution
-
Harderwijk、荷兰、3844 DG
- Local Institution
-
Hertogenbosch、荷兰、5223 GZ
- Local Institution
-
Nieuwegein、荷兰、3435 CM
- Local Institution
-
-
-
-
-
Lisboa、葡萄牙、1099023
- Local Institution
-
Lisboa、葡萄牙、1769-001
- Local Institution
-
Porto、葡萄牙、4200-072
- Local Institution
-
Santa Maria Da Feira、葡萄牙、4520211
- Local Institution
-
Vila Nova De Gaia、葡萄牙、4434-502
- Local Institution
-
-
Coimbra
-
Sao Martinho Do Bispo、Coimbra、葡萄牙、3041801
- Local Institution
-
-
-
-
-
Avila、西班牙、05004
- Local Institution
-
Benidorm-alicante、西班牙、03501
- Local Institution
-
Castellon、西班牙、12002
- Local Institution
-
Madrid、西班牙、28041
- Local Institution
-
Madrid、西班牙、28033
- Local Institution
-
Manresa、西班牙、08243
- Local Institution
-
Ourense、西班牙、32005
- Local Institution
-
Valencia、西班牙、46014
- Local Institution
-
Valencia、西班牙、46015
- Local Institution
-
-
Vizcaya
-
Barakaldo、Vizcaya、西班牙、48903
- Local Institution
-
-
-
-
-
Cordoba、阿根廷、X5006HBF
- Local Institution
-
Cordoba、阿根廷、X5006IKK
- Local Institution
-
Mendoza、阿根廷、M5500AYB
- Local Institution
-
Santa Fe、阿根廷、S3000FFU
- Local Institution
-
-
Buenos Aires
-
Quilmes、Buenos Aires、阿根廷、B1878DVB
- Local Institution
-
-
Santa FE
-
Rosario、Santa FE、阿根廷、S2000DSV
- Local Institution
-
-
Tucuman
-
San Miguel De Tucuman、Tucuman、阿根廷、4000
- Local Institution
-
-
-
-
-
Hong Kong、香港、8525
- Local Institution
-
Hong Kong、香港
- Local Institution
-
New Territories、香港、8520
- Local Institution
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Brain Metastases
- Autoimmune diseases
学习计划
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
其他名称:
其他名称:
其他名称:
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安慰剂比较:Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
其他名称:
其他名称:
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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 |
---|---|---|
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
大体时间:Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
大体时间:Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
大体时间:Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first.
A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death.
For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的