北京GA101III期临床试验-比较G-CHOP与R-CHOP在初治CD20阳性(DLBCL)患者中的疗效
北京中国医学科学院肿瘤医院开展的GA101III期临床试验信息,需要患者受试者,主要适应症为CD20阳性弥漫大B细胞淋巴瘤
| 登记号 | CTR20130792 | 试验状态 | 已完成 |
|---|---|---|---|
| 申请人联系人 | 刘圆 | 首次公示信息日期 | 2014-05-20 |
| 申请人名称 | F. Hoffmann-La Roche AG/ Roche Diagnostics GmbH/ F.Hoffmann-La Roche Ltd./ 上海罗氏制药有限公司 | ||
一、题目和背景信息
| 登记号 | CTR20130792 | ||
|---|---|---|---|
| 相关登记号 | CTR20130805; CTR20140111; CTR20131156 | ||
| 药物名称 | GA101 | ||
| 药物类型 | 生物制品 | ||
| 临床申请受理号 | 企业选择不公示 | ||
| 适应症 | CD20阳性弥漫大B细胞淋巴瘤 | ||
| 试验专业题目 | III期、多中心、开放、随机的临床试验,比较G-CHOP与R-CHOP在初治的CD20阳性的弥漫大B细胞淋巴瘤患者中的疗效 | ||
| 试验通俗题目 | 比较G-CHOP与R-CHOP在初治CD20阳性(DLBCL)患者中的疗效 | ||
| 试验方案编号 | BO21005; 第A5版 | 方案最新版本号 | 暂无 |
| 版本日期: | 暂无 | 方案是否为联合用药 | 企业选择不公示 |
二、申请人信息
| 申请人名称 |
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| 联系人姓名 | 刘圆 | 联系人座机 | 021-28922994 | 联系人手机号 | 暂无 |
| 联系人Email | demi.liu@roche.com | 联系人邮政地址 | 上海市浦东新区龙东大道1100号 | 联系人邮编 | 201203 |
三、临床试验信息
1、试验目的
本研究的主要目的是基于研究者评估的无进展生存期(PFS),证明初治的CD20阳性的弥漫大B 细胞淋巴瘤患者在接受GA101 联合化疗(CHOP)后,PFS 优于利妥昔单抗联合化疗。 2、试验设计
| 试验分类 | 有效性 | 试验分期 | III期 | 设计类型 | 平行分组 |
|---|---|---|---|---|---|
| 随机化 | 随机化 | 盲法 | 开放 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 年龄 | 18岁(最小年龄)至 N/A岁(最大年龄) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 性别 | 男+女 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 健康受试者 | 无 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 入选标准 |
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| 排除标准 |
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4、试验分组
| 试验药 |
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| 对照药 |
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5、终点指标
| 主要终点指标及评价时间 |
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| 次要终点指标及评价时间 |
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四、研究者信息
1、主要研究者信息
| 1 | 姓名 | 石远凯,医学博士 | 学位 | 暂无 | 职称 | 教授 |
|---|---|---|---|---|---|---|
| 电话 | 010-87788269 | syuankai@yahoo.cn | 邮政地址 | 北京市左安门外朝阳区潘家园南里17号 | ||
| 邮编 | 100021 | 单位名称 | 中国医学科学院肿瘤医院 | |||
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家 | 省(州) | 城市 |
|---|---|---|---|---|---|
| 1 | 中国医学科学院肿瘤医院 | 石远凯 | 中国 | 北京 | 北京 |
| 2 | 第四军医大学第二附属医院 | 梁英明 | 中国 | 陕西 | 西安 |
| 3 | 中国人民解放军总医院 | 于力 | 中国 | 北京 | 北京 |
| 4 | 广东省人民医院 | 杜欣 | 中国 | 广东 | 广州 |
| 5 | 华中科技大学同济医学院附属协和医院 | 伍钢(肿瘤科)胡豫(血液科) | 中国 | 湖北 | 武汉 |
| 6 | 天津市肿瘤医院 | 王华庆 | 中国 | 天津 | 天津 |
| 7 | 复旦大学附属肿瘤医院 | 洪小南 | 中国 | 上海 | 上海 |
| 8 | 浙江大学医学院附属第一医院 | 金洁 | 中国 | 浙江 | 杭州 |
| 9 | 福建省肿瘤医院 | 杨瑜 | 中国 | 福建 | 福州 |
| 10 | 福建医科大学附属协和医院 | 胡建达 | 中国 | 福建 | 福州 |
| 11 | 江苏省肿瘤医院 | 冯继峰 | 中国 | 江苏 | 南京 |
| 12 | 上海瑞金医院 | 李军民 | 中国 | 上海 | 上海 |
| 13 | 上海长海医院 | 王健民 | 中国 | 上海 | 上海 |
| 14 | 苏州大学附属第一医院 | 吴德沛 | 中国 | 江苏 | 苏州 |
| 15 | 广西医科大学第一附属医院 | 赖永榕 | 中国 | 广西 | 南宁 |
| 16 | 南京医科大学第一附属医院 | 李建勇 | 中国 | 江苏 | 南京 |
| 17 | 中国医科大学附属第一医院 | 李艳 | 中国 | 辽宁 | 沈阳 |
| 18 | 中山大学肿瘤防治中心 | 黄慧强 | 中国 | 广东 | 广州 |
| 19 | 卫生部北京医院 | 刘辉 | 中国 | 北京 | 北京 |
| 20 | 湖南省肿瘤医院 | 易平勇 | 中国 | 湖南 | 长沙 |
| 21 | 南昌大学第二附属医院 | 石庆之 | 中国 | 江西 | 南昌 |
| 22 | 苏州大学附属第二医院 | 傅晋翔 | 中国 | 江苏 | 苏州 |
| 23 | 北京大学第一医院 | 任汉云 | 中国 | 北京 | 北京 |
| 24 | 吉林大学第一医院 | 李薇 | 中国 | 吉林 | 长春 |
| 25 | 军事医学科学院附属医院 | 张伟京 | 中国 | 北京 | 北京 |
| 26 | 北京肿瘤医院 | 朱军 | 中国 | 北京 | 北京 |
| 27 | 哈尔滨医科大学附属肿瘤医院 | 张清媛 | 中国 | 黑龙江 | 哈尔滨 |
| 28 | Instituto Damic | PILNIK NORMA | ARGENTINA | Cordoba | Cordoba |
| 29 | Sanatorio Britanico: Hematologia | Cerana Helvecia Susana | ARGENTINA | Rosario | Rosario |
| 30 | SANATORIO PARQUE DE ROSARIO | Basso Alfredo | ARGENTINA | Rosario | Rosario |
| 31 | FRANKSTON HOSPITAL; ONCOLOGY/HAEMATOLOGY | CATALANO JOHN | AUSTRALIA | Victoria | FRANKSTON |
| 32 | MONASH MEDICAL CENTRE; HAEMATOLOGY | Opat Stephen | AUSTRALIA | Victoria | MELBOURNE |
| 33 | ROYAL PERTH HOSPITAL; HAEMATOLOGY | CANNELL PAUL | AUSTRALIA | Western Australia | PERTH |
| 34 | LKH SALZBURG - UNIV. KLINIKUM SALZBURG; III. MEDIZINISCHE ABT. | GREIL RICHARD | AUSTRIA | Salzburg | Salzburg |
| 35 | TIROLER LANDESKRANKENANSTALTEN GESMBH INNERE MEDIZIN ABT FüR H MATOLOGIE & ONKOLOGIE | Willenbacher Ella | AUSTRIA | INNSBRUCK | INNSBRUCK |
| 36 | UNIVERSIT TSKLINIK FüR INNERE MEDIZIN I; ABT. HEMATOLOGIE & HEMOSTASEOLOGIE | JAEGER ULRICH G. | AUSTRIA | WIEN | WIEN |
| 37 | Capital Health; QEII HSC; Oncology | MACDONALD DAVID | CANADA | Nova Scotia | HALIFAX |
| 38 | Centre de sante et de services sociaux Rimouski Neigette | Allard Joffre | CANADA | Quebec | Rimouski |
| 39 | CHUM HOPITAL NOTRE DAME; CENTRE D'ONCOLOGIE | Lemieux Bernard | CANADA | Quebec | MONTREAL |
| 40 | Cross Cancer Institute | Chua Neil | CANADA | Alberta | EDMONTON |
| 41 | HOPITAL MAISONNEUVE- ROSEMONT; ONCOLOGY | Mollica Luigina | CANADA | Quebec | MONTREAL |
| 42 | Mcgill University - Royal Victoria Hospital; Oncology | Johnson Nathalie | CANADA | Quebec | MONTREAL |
| 43 | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Johnson Nathalie | CANADA | Quebec | MONTREAL |
| 44 | NORTH YORK GENERAL HOSPITAL | ROITMAN DARYL | CANADA | Ontario | TORONTO |
| 45 | TOM BAKER CANCER CENTRE; DEPT OF MEDICINE | STEWART DOUGLAS | CANADA | Alberta | Calgary |
| 46 | TOM BAKER CANCER CENTRE; DEPT OF MEDICINE | STEWART DOUGLAS | CANADA | Alberta | Calgary |
| 47 | University Health Network; Princess Margaret Hospital; Medical Oncology | CRUMP MICHAEL | CANADA | Ontario | Toronto |
| 48 | Organizacion Sanitas Internacional | Ramirez Carlos | COLOMBIA | Bogota | Bogota |
| 49 | Fakultni nemocnice Brno; Interni hematoonkologicka klinika | MAYER JIRI | CZECH REPUBLIC | BRNO | BRNO |
| 50 | Fn Hr. Kralove; IV. Interni Hematologicka Klinika | BELADA DAVID | CZECH REPUBLIC | Hradec Kralove | Hradec Kralove |
| 51 | Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK | TRNENY MAREK | CZECH REPUBLIC | PRAHA 2 | PRAHA 2 |
| 52 | Aarhus Universitetshospital, Hematologisk Afdeling R | Jorgensen Judith | DENMARK | RHUS | RHUS |
| 53 | Righospitalet, H matologisk Klinik | Brown Peter | DENMARK | Kbenhavn | Kbenhavn |
| 54 | Friedrich-Alexander-Universitt Erlangen-Nürnberg; Medizinische Klinik V | Krause Stefan | GERMANY | Erlangen | Erlangen |
| 55 | KLINIK DER JUSTUS-LIEBIG-UNI; INNERE MEDIZIN | Rummel Mathias | GERMANY | Giessen | Giessen |
| 56 | Onkologische Schwerpunktpraxis Kurfürstendamm | Schwaner Ingo | GERMANY | Berlin | Berlin |
| 57 | Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V | Witzens-Harig Mathias | GERMANY | Heidelberg | Heidelberg |
| 58 | UNI-Klinikum Carl Gustav Carus | Kroschinsky Frank | GERMANY | Dresden | Dresden |
| 59 | Universit tsklinikum Aachen Medizinische Klinik IV | Kurz-zur Hausen Anna Kordelia | GERMANY | Aachen | Aachen |
| 60 | Universit tsklinikum Würzburg Medizinische Klinik und Poliklinik II | Topp Max | GERMANY | Wuerzburg | Wuerzburg |
| 61 | Pamela Youde Nethersole Eastern Hospital; Department of Medicine | Liu Herman Sung-Yu | 中国 | HONG KONG | HONG KONG |
| 62 | QUEEN MARY HOSPITAL; DEPT OF MEDICINE | Kwong Yok-Lam | 中国 | HONG KONG | HONG KONG |
| 63 | Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology | EGYED MIKLOS | HUNGARY | KAPOSVAR | KAPOSVAR |
| 64 | National Institute of Oncology, A Dept of Internal Medicine | ROSTA ANDRAS | HUNGARY | BUDAPEST | BUDAPEST |
| 65 | PETZ ALADAR MEGYEI KORHAZ; HEMATOLOGIA | GASZTONYI ZOLTAN | HUNGARY | GYOR | GYOR |
| 66 | Semmelweis University, First Dept of Medicine | DEMETER JUDIT | HUNGARY | BUDAPEST | BUDAPEST |
| 67 | St. Istvan and St. Laszlo Hospital | MASSZI TAMAS | HUNGARY | BUDAPEST | BUDAPEST |
| 68 | University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B | ILLES ARPAD | HUNGARY | Debrecen | Debrecen |
| 69 | University of Szeged, II Dept of Internal Medicine | BORBENYI ZITA | HUNGARY | SZEGED | SZEGED |
| 70 | A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna | ZINZANI PIERLUIGI | ITALY | Emilia-Romagna | BOLOGNA |
| 71 | A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1 | Cavallo Federica | ITALY | Piemonte | TORINO |
| 72 | A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 2 | VITOLO UMBERTO | ITALY | Piemonte | TORINO |
| 73 | A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica | ZAJA FRANCESCO | ITALY | Friuli-Venezia Giulia | UDINE |
| 74 | A.O. Universitaria S. Martino Di Genova; Ematologia 1 | CARELLA ANGELO MICHELE | ITALY | Liguria | GENOVA |
| 75 | AZ. OSP. C. PANICO; REP. EMATOLOGIA E TRAPIANTO | PAVONE VINCENZO | ITALY | Puglia | TRICASE - LE |
| 76 | AZ. OSP. PAPARDO; STRUTTURA COMPLESSA DI EMATOLOGIA | Mannina Donato | ITALY | Sicilia | MESSINA |
| 77 | AZ. OSP. S. LUIGI GONZAGA; S.C.D.U. MEDICINA INTERNA II | PARVIS GUIDO | ITALY | Piemonte | ORBASSANO |
| 78 | AZ. OSP. S. MARIA; DEPT. DI ONCOLOGIA MEDICA | LIBERATI ANNA MARINA | ITALY | Umbria | TERNI |
| 79 | AZ. OSP. SPEDALI CIVILI; STRUTTURA SEMPLICE DI EMATOLOGIA | ROSSI GIUSEPPE | ITALY | Lombardia | BRESCIA |
| 80 | Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia | MARTINELLI GIOVANNI | ITALY | Lombardia | MILANO |
| 81 | IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo | Cascavilla Nicola | ITALY | Puglia | SAN GIOVANNI ROTONDO |
| 82 | IRCCS POLICLINICO SAN MATTEO; DIVISIONE DI EMATOLOGIA | Arcaini Luca | ITALY | Lombardia | PAVIA |
| 83 | ISTITUTO TUMORI FONDAZIONE PASCALE; DIVISIONE DI EMATOLOGIA ONCOLOGIA | PINTO ANTONIO | ITALY | Campania | NAPOLI |
| 84 | IST. NAZIONALE PER LO STUDIO E CURA DEI TUMORI; DIV. EMATOLOGIA TRAPIANTO MIDOLLO OSSEO ALLOGENICO | CORRADINI PAOLO | ITALY | Lombardia | MILANO |
| 85 | Ospedale | D'ARCO ALFONSO | ITALY | Campania | Pagani (Sa) |
| 86 | Ospedale Ca Foncello; Ematologia | GHERLINZONI FILIPPO | ITALY | Veneto | TREVISO |
| 87 | Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia | Salvi Flavia | ITALY | Piemonte | ALESSANDRIA |
| 88 | Ospedale Di Vicenza; Nefrologia, Ematologia | VISCO CARLO | ITALY | Veneto | VICENZA |
| 89 | OSPEDALE RIUNITI; DIVISIONE DI EMATOLOGIA | Stelitano Caterina | ITALY | Calabria | REGGIO CALABRIA |
| 90 | OSPEDALE SANTA CHIARA; UNITA OPERATIVA DI EMATOLOGIA | PETRINI MARIO | ITALY | Toscana | PISA |
| 91 | Ospedali Riuniti del Canavese | Freilone Roberto | ITALY | Piemonte | Ivrea |
| 92 | Ospedale | D'ARCO ALFONSO | ITALY | Campania | NOCERA INFERIORE |
| 93 | UNI DEGLI STUDI DI BARI, POLICLINICO; CATTEDRA DI EMATOLOGIA,DIPART. DI MEDICINA INTERNA E PUBLICA | Specchia Giorgina | ITALY | Puglia | BARI |
| 94 | UNI DI VERONA POLICLINICO G.B. ROSSI; DIVISIONE E CATTEDRA DI EMATOLOGIA | PIZZOLO GIOVANNI | ITALY | Veneto | VERONA |
| 95 | UNI LA SAPIENZA, ISTITUTO DI EMATOLOGIA; DEPT. DI BIOTECHNOLOGIE CELLULARI ED EMATOLOGIA | MARTELLI MAURIZIO | ITALY | Lazio | ROMA |
| 96 | UNIV. PIEMONTE EST AMEDEO AVOGADRO; DIV.EMATOLOGIA- DIP.CLINICA MED.SPERIM.& IRCAD | GAIDANO GIANLUCA | ITALY | Piemonte | NOVARA |
| 97 | Chiba University Hospital; Hematology | Nakaseko Chiaki | JAPAN | Chiba | Chiba |
| 98 | Gifu University Hospital; First Department of Internal Medicine | Tsurumi Hisashi | JAPAN | Gifu | Gifu |
| 99 | Hokkaido University Hospital; Hematology | Teshima Takanori | JAPAN | Hokkaido | Hokkaido |
| 100 | Iwate Medical University Hospital;Hematology and Oncology | Ishida Yoji | JAPAN | Iwate | Iwate |
| 101 | Jichi Medical University Hospital; Hematology | Ohmine Ken | JAPAN | Tochigi | Tochigi |
| 102 | Kobe City Medical Center General Hospital; Hematology and Clinical Immunology | Ishikawa Takayuki | JAPAN | Hyogo | Hyogo |
| 103 | Kurashiki Central Hospital; Hematology | Ueda Yasunori | JAPAN | Okayama | Okayama |
| 104 | Kurume University Hospital; Hematology and Oncology | Nagafuji Koji | JAPAN | Fukuoka | Fukuoka |
| 105 | Kyoto University Hospital; Department of Hematology/Oncology | Kitano Toshiyuki | JAPAN | Kyoto | Kyoto |
| 106 | Nagoya Daini Red Cross Hospital; Hematology & Oncology | Uchida Toshiki | JAPAN | Aichi | Aichi |
| 107 | OTTAWA GENERAL HOSPITAL | Isabelle Bence Bruckler | CANADA | Ontario | Ottawa |
| 108 | HOPITAL DE L'ENFANT-JESUS; HEMATOLOGY | Jean-Francois Larouche | CANADA | Quebec | Quebec |
| 109 | BCCA-Vancouver Cancer Centre | Laurie Sehn | CANADA | British Columbia | Vancouver |
| 110 | SASKATOON CANCER CENTRE; UNI OF SASKATOON CAMPUS | Mohamed Elemary | CANADA | Saskatchewan | Saskatoon |
| 111 | Hospital Sao Lucas - PUCRS | Viola Luciana | BRAZIL | RS | Porto Alegre |
| 112 | Hospital Santa Marcelina;Oncologia | Barreto Wolney | BRAZIL | SP | Sao Paulo |
| 113 | Fundacion Cardioinfantil | Segovia Javier | COLOMBIA | Bogota | Bogota |
| 114 | Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium | Bjorn Poulsen Christian | DENMARK | Roskilde | Roskilde |
| 115 | St. Istvan and St. Laszlo Hospital ; Dept of Hematology and Stem Cell Transplantation | Mikala Gabor | HUNGARY | BUDAPEST | BUDAPEST |
| 116 | Azienda Ospedaliera Univ | BOSI ALBERTO | ITALY | Toscana | Firenze |
| 117 | Hospital San Raffaele | Ferreri Andres | ITALY | Lombardia | Milano |
| 118 | Azienda Ospedaliero Univ | DI RAIMONDO FRANCESCO | ITALY | Sicilia | Catania |
| 119 | AO Santa Maria Nuova; U.O. Day Hospital di Oncologi | MERLI FRANCESCO | ITALY | Emilia-Romagna | Reggio Emilia |
| 120 | National Cancer Center Hospital; Hematology | Maruyama Dai | JAPAN | TOKYO | TOKYO |
| 121 | Toranomon Hospital; Hematology | Yamamoto Go | JAPAN | TOKYO | TOKYO |
| 122 | Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease | Nakajima Hideaki | JAPAN | Kanagawa | Kanagawa |
| 123 | Nippon Medical School Hospital; Hematology | Tamura Hideto | JAPAN | Tokyo | Tokyo |
| 124 | Osaka City University Hospital; Hematology | Nakamae Hirohisa | JAPAN | Osaka | Osaka |
| 125 | Shimane University Hospital;Hematology | Suzumiya Junji | JAPAN | SHIMANE | SHIMANE |
| 126 | The Cancer Institute Hospital of JFCR; Hematology Oncology | HATAKE KIYOHIKO | JAPAN | Tokyo | Tokyo |
| 127 | Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine | Akashi Koichi | JAPAN | Fukuoka | Fukuoka |
| 128 | Kyoto University Hospital; Department of Hematology/Oncology | Nishikori Momoko | JAPAN | Kyoto | Kyoto |
| 129 | Niigata Cancer Center Hospital; Internal Medicine | Chou Takaaki | JAPAN | Niigata | Niigata |
| 130 | Kindai University Hospital; Hematology and Rheumatology | Tatsumi Yoichi | JAPAN | Osaka | Osaka |
| 131 | Osaka University Hospital; Hematology and Oncology | Kanakura Yuzuru | JAPAN | OSAKA | OSAKA |
| 132 | Asan Medical Center | Suh Cheolwon | KOREA | Seoul | Seoul |
| 133 | National Cancer Center | Eom Hyeon Seok | KOREA | Gyeonggi-do | Gyeonggi-do |
| 134 | Chonnam National University Hwasun Hospital | Lee Je-Jung | KOREA | Jeollanam-do | Jeollanam-do |
| 135 | Yonsei University Severance Hospital; Medical Oncology | Kim Jin Seok | KOREA | Seoul | Seoul |
| 136 | ST. MARY'S HOSPITAL, THE CATHOLIC UNIVERSITY SCHOOL OF MEDICINE; INTERNAL MEDICINE | Cho Seok Goo | KOREA | Seoul | Seoul |
| 137 | Seoul National University Hospital | Kim Tae Min | KOREA | Seoul | Seoul |
| 138 | Samsung Medical Center | Kim WONSEOG | KOREA | Seoul | Seoul |
| 139 | Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre | Zaragoza Vazquez Alva Nora | MEXICO | CHIHUAHUA | CHIHUAHUA |
| 140 | HOSPITAL UNIVERSITARIO DR. JOSE E. GONZALEZ; HAEMATOLOGY | GOMEZ-ALMAGUER DAVID | MEXICO | MONTERREY | MONTERREY |
| 141 | Oaxaca Site Management Organization | Ramirez Romero Eva Fabiola | MEXICO | Oaxaca | Oaxaca |
| 142 | Centro de Estudios Clinicos de Queretaro, SC | Gonzalez Lopez Elizalde Montserrat | MEXICO | Queretaro | Queretaro |
| 143 | Centro Hemato Oncologico Paitilla | Quiel Dimas | PANAMA | Panama City | Panama City |
| 144 | Instituto;Oncologico Miraflores | CASANOVA LUIS | PERU | Lima | Lima |
| 145 | Clinica de Especialidades Medicas | Valdiviezo Natalia | PERU | Lima | Lima |
| 146 | Instituto Nacional de Enfermedades Neoplasicas | Quintana Shirley | PERU | Lima | Lima |
| 147 | Szpital Specjalistyczny Podkarpacki Orodek Onkologiczny | Pluta Andrzej | POLAND | Brzozów | Brzozów |
| 148 | Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii | HELLMANN ANDRZEJ | POLAND | Gdansk | Gdansk |
| 149 | Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego | WALEWSKI JAN | POLAND | Warszawa | Warszawa |
| 150 | MEDICAL UNI OF WROCLAW; HEMATOLOGY | KULICZKOWSKI KAZIMIERZ | POLAND | WROCLAW | WROCLAW |
| 151 | Medical University of Lodz; Hematology | ROBAK TADEUSZ | POLAND | Lodz | Lodz |
| 152 | Republican Clinical Hospital n.a. Baranov; Haematology | MYASNIKOV ALEXANDR | RUSSIAN FEDERATION | Petrozavodsk | Petrozavodsk |
| 153 | CLINICAL ONCOLOGY DISPENSARY OF MINISTRY OF HEALTH OF TATARSTAN | Kuzmin Alexey | RUSSIAN FEDERATION | KAZAN | KAZAN |
| 154 | BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY | OSMANOV DZHELIL | RUSSIAN FEDERATION | MOSCOW | MOSCOW |
| 155 | REGIONAL CLINICAL HOSPITAL N.A. SEMASHKO; HEMATOLOGY | SAMOYLOVA OLGA | RUSSIAN FEDERATION | NIZHNY NOVGOROD | NIZHNY NOVGOROD |
| 156 | RESEARCH INST. OF HEMATOLOGY & BLOOD TRANSFUSION ; HEMATOLOGY | Voloshin Sergey | RUSSIAN FEDERATION | ST PETERSBURG | ST PETERSBURG |
| 157 | Penza Regional Oncology Dispensary | Chagorova Tatiana | RUSSIAN FEDERATION | Penza | Penza |
| 158 | INSTITUTE OF HEMATOLOGY | MIHALJEVIC BILJANA | SERBIA | BELGRADE | BELGRADE |
| 159 | Clinical Center Vojvodine; Clinic for Hematology | SAVIC IVANKA | SERBIA | Novi Sad | Novi Sad |
| 160 | NATIONAL ONCOLOGY INST. ; DEPT. OF HAEMATOLOGY | VRANOVSKY ANDREJ | SLOVAKIA | BRATISLAVA | BRATISLAVA |
| 161 | Drs Thomson, Brittain an Partners Inc | McDonald Andrew | SOUTH AFRICA | Pretoria | Pretoria |
| 162 | MEDICAL ONCOLOGY CENTRE OF ROSEBANK; ONCOLOGY | RAPOPORT BERNARDO | SOUTH AFRICA | Johannesburg | Johannesburg |
| 163 | Mary Potter Oncology Centre | COHEN GRAHAM | SOUTH AFRICA | Groenkloof | Groenkloof |
| 164 | Wits Donald Gordon Clinical Trial Centre; Medical Oncology | RUFF PAUL | SOUTH AFRICA | Parktown, Johannesburg | Parktown, Johannesburg |
| 165 | Hospital del Mar; Servicio de Hematologia | Salar Silvestre Antonio | SPAIN | Barcelona | Barcelona |
| 166 | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Gine Soca Eva | SPAIN | Barcelona | Barcelona |
| 167 | Hospital Duran i Reynals; Servicio de Hematologia | Gonzalez Barca Eva | SPAIN | BARCELONA | BARCELONA |
| 168 | Hospital Ramon y Cajal; Servicio de Hematologia | Lopez Jimenez Javier | SPAIN | Madrid | Madrid |
| 169 | Hospital Universitario Virgen Macarena; Servicio de Oncologia | De La Cruz Merino Luis | SPAIN | SEVILLA | SEVILLA |
| 170 | Hospital Universitari Vall d'Hebron; Servicio de Hematologia | Gironella Mesa Mercedes | SPAIN | Barcelona | Barcelona |
| 171 | Hospital de Navarra, Servicio de Hematología | Rodriguez Calvillo Mercedes | SPAIN | NAVARRA | PAMPLONA |
| 172 | Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Alvarez Ruth | SPAIN | TOLEDO | TOLEDO |
| 173 | Universitts Spital Zürich; Zentrum für H?matologie und Onkologie, Klinik für Onkologie | Theocharides Alexandre | SWITZERLAND | Zürich | Zürich |
| 174 | KANTONSSPITAL AARAU; ZENTRUM FüR ONKOLOGIE, HEMATOLOGIE & TRANSFUSIONSMEDIZIN | Mamot Christoph | SWITZERLAND | Aarau | Aarau |
| 175 | OSPEDALE SAN GIOVANNI; ONCOLOGIA | ZUCCA EMANUELE | SWITZERLAND | Bellinzona | Bellinzona |
| 176 | Kantonsspital Graubünden;Onkologie und Hematologie | Mey Ulrich | SWITZERLAND | Chur | Chur |
| 177 | Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Chang Hung | 中国 | Taoyuan | Taoyuan |
| 178 | VETERANS GENERAL HOSPITAL; DIVISION OF ONCOLOGY | HSIAO LIANG-TSAI | 中国 | TAIPEI | TAIPEI |
| 179 | KOO FOUNDATION SUN YAT-SEN CANCER CENTER; HEMATO-ONCOLOGY | Chiou Lun-Wei | 中国 | TAIPEI | TAIPEI |
| 180 | SRINAGARIND HOSPITAL, KHON KAEN UNI ; DEPT OF MEDICINE | CHANSUNG KANCHANA | THAILAND | KHON KAEN | KHON KAEN |
| 181 | SIRIRAJ HOSPITAL; DIVISION OF HEMATOLOGY, DEPARTMENT OF MEDICINE | SIRITANARATKUL NOPPADOL | THAILAND | BANGKOK | BANGKOK |
| 182 | RAJAVITHI HOSPITAL; MEDICINE | THUNGTHONG PRAVINWAN | THAILAND | BANGKOK | BANGKOK |
| 183 | RAMATHIBODI HOSPITAL; DIVISION OF HEMATOLOGY, DEPARTMENT OF MEDICINE | CHUNCHARUNEE SUPORN | THAILAND | Bangkok | Bangkok |
| 184 | KING CHULALONGKORN MEMORIAL HOSPITAL; DIVISION OF HEMATOLOGY, DEPARTMENT OF MEDICINE | Bunworasate Udomsak | THAILAND | Bangkok | Bangkok |
| 185 | NATIONAL CANCER INST. | ARPORNWIRAT WICHIT | THAILAND | Bangkok | Bangkok |
| 186 | Aberdeen Royal Infirmary; Haematology - Ward 16 | Culligan Dominic | UNITED KINGDOM | ABERDEEN | ABERDEEN |
| 187 | ADDENBROOKES HOSPITAL; HAEMATOLOGY | Follows George | UNITED KINGDOM | Cambridge | Cambridge |
| 188 | The HOPE Clinical Trials Unit | Dyer Martin | UNITED KINGDOM | Leicester | Leicester |
| 189 | BIRMINGHAM HEARTLANDS HOSPITAL; DEPARTMENT OF HAEMATOLOGY | Paneesha Shankara | UNITED KINGDOM | BIRMINGHAM | BIRMINGHAM |
| 190 | New Cross Hospital; Dept. Of Haematology | Basu Supratik | UNITED KINGDOM | WOLVERHAMPTON | WOLVERHAMPTON |
| 191 | cCare | Bessudo Alberto | UNITED KINGDOM | CA | ENCINITAS |
| 192 | Cancer Care Centers of South Texas-HOAST - San Antonio | Zweibach Alexander | UNITED KINGDOM | TX | New Braunfels |
| 193 | University of Alabama at Birmingham | Forero-Torres Andres | UNITED KINGDOM | AL | Birmingham |
| 194 | Arizona Oncology | Di Simone Christopher | UNITED KINGDOM | AZ | Tucson |
| 195 | Florida Cancer Specialists; Saint Petersburg | WRIGHT DAVID | UNITED STATES | FL | St Petersburg |
| 196 | Illinois Cancer Care, P.C. - Galesburg | Prage人Diane | UNITED STATES | IL | Galesburg |
| 197 | Chattanooga Oncology and Hematology Associates, PC | Arrowsmith Edward | UNITED STATES | TN | Chattanooga |
| 198 | FORSYTH REGIONAL CANCER CENTER; PIEDMONT HEMATOLOGY/ONCOLOGY ASSOCIATES | Chen Franklin | UNITED STATES | NC | Winston-Salem |
| 199 | Central Georgia Cancer Care PC | SCHNELL FREDERICK M. | UNITED STATES | GA | Macon |
| 200 | South Carolina Oncology Associates - SCRI | KudrikFred J. | UNITED STATES | SC | Columbia |
| 201 | Tennessee Onc., PLLC - SCRI | Flinn Ian | UNITED STATES | TN | Nashville |
| 202 | Joliet Oncology-Hematology; Associates, Ltd. | Suh Jason | UNITED STATES | IL | Joliet |
| 203 | Willamette Valley Cancer Insitute and Research Center | Sharman Jeff-Porter | UNITED STATES | OR | Springfield |
| 204 | Blue Ridge Cancer Care | Goldschmidt-Jr Jerome | UNITED STATES | VA | Roanoke |
| 205 | Rocky Mountain Cancer Center - Aurora | Burke John M. | UNITED STATES | CO | Aurora |
| 206 | Northwest Medical Specialties | Chaves Jorge Mario | UNITED STATES | WA | Tacoma |
| 207 | Virginia Cancer Institute | McFarlane Joshua | UNITED STATES | VA | Richmond |
| 208 | NEW YORK ONCOLOGY HEMATOLOGY, P.C. | GARBO LAWRENCE | UNITED STATES | NY | Albany |
| 209 | Cancer Care & Hematology; Specialists of Chicagoland | KLEIN LEONARD | UNITED STATES | IL | Niles |
| 210 | MD Anderson Cancer Center Department of Lymphoma & Myeloma | Fayad Luis | UNITED STATES | TX | Houston |
| 211 | CARLE CANCER CENTER | Grosse-Perdekamp Maria | UNITED STATES | IL | Urbana |
| 212 | Wenatchee Valley Hospital & Clinics | Garrison Mitchell | UNITED STATES | WA | Wenatchee |
| 213 | Minnesota Oncology Hematology Woodbury | FLYNN PATRICK J. | UNITED STATES | MN | Woodbury |
| 214 | Park Nicollet Clin-Cancer Ctr | Lerner Rachel | UNITED STATES | MN | ST LOUIS PARK |
| 215 | Medical University of SC (MUSC) | Stuart Robert | UNITED STATES | SC | CHARLESTON |
| 216 | Florida Cancer Specialists; Department of Oncology | Lunin Scott | UNITED STATES | FL | Fort Myers |
| 217 | Virginia Cancer Specialists - Winchester | Houck William | UNITED STATES | VA | Winchester |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | 南昌大学第二附属医院医学伦理委员会 | 同意 | 2013-01-30 |
| 2 | 苏州大学附属第二医院国家药物临床试验机构伦理委员会 | 同意 | 2013-02-07 |
| 3 | 苏州大学附属第一医院医学伦理委员会 | 同意 | 2013-03-19 |
| 4 | 中国医科大学附属第一医院医学伦理委员会 | 同意 | 2013-04-24 |
| 5 | 上海长海医院伦理委员会 | 同意 | 2013-06-30 |
| 6 | 军事医学科学院附属医院药物临床试验伦理委员会 | 同意 | 2013-07-01 |
| 7 | 江苏省肿瘤医院伦理委员会 | 同意 | 2013-07-03 |
| 8 | 中国人民解放军总医院医学伦理委员会 | 同意 | 2013-07-11 |
| 9 | 中山大学肿瘤防治中心伦理委员会 | 同意 | 2013-07-17 |
| 10 | 中国医学科学院肿瘤医院伦理委员会 | 同意 | 2013-07-18 |
| 11 | 中国医学科学院肿瘤医院伦理委员会 | 同意 | 2013-07-19 |
| 12 | 浙江大学医学院附属第一医院伦理委员会 | 同意 | 2013-07-22 |
| 13 | 华中科技大学药物临床试验伦理委员会(肿瘤科) | 同意 | 2013-07-30 |
| 14 | 第四军医大学唐都医院伦理委员会 | 同意 | 2013-07-30 |
| 15 | 华中科技大学药物临床试验伦理委员会(血液科) | 同意 | 2013-07-30 |
| 16 | 北京大学第一医院伦理委员会 | 同意 | 2013-08-07 |
| 17 | 哈尔滨医科大学附属肿瘤医院伦理委员会 | 同意 | 2013-08-09 |
| 18 | 南京医科大学第一附属医院伦理委员会 | 同意 | 2013-08-12 |
| 19 | 吉林大学第一医院伦理委员会 | 同意 | 2013-08-13 |
| 20 | 北京肿瘤医院医学伦理委员会 | 同意 | 2013-08-13 |
| 21 | 上海瑞金医院伦理委员会 | 同意 | 2013-08-20 |
| 22 | 福建省肿瘤医院伦理委员会 | 同意 | 2013-08-21 |
| 23 | 卫生部北京医院伦理委员会 | 同意 | 2013-08-21 |
| 24 | 复旦大学附属肿瘤医院医学伦理委员会 | 同意 | 2013-09-22 |
| 25 | 福建医科大学附属协和医院伦理委员会 | 同意 | 2013-09-28 |
| 26 | 广西医科大学第一附属医院医学伦理委员会 | 同意 | 2013-11-05 |
| 27 | 天津市肿瘤医院医学伦理委员会 | 同意 | 2013-12-25 |
| 28 | 湖南省肿瘤医院伦理委员会 | 同意 | 2013-12-29 |
| 29 | 广东省人民医院医学伦理委员会 | 同意 | 2014-01-09 |
六、试验状态信息
1、试验状态
已完成
2、试验人数
| 目标入组人数 | 国内: 250 ; 国际: 1400 ; |
|---|---|
| 已入组人数 | 国内: 登记人暂未填写该信息; 国际: 登记人暂未填写该信息; |
| 实际入组总人数 | 国内: 253 ; 国际: 1418 ; |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 | 国内:2013-04-19; 国际:2011-07-26; |
|---|---|
| 第一例受试者入组日期 | 国内:登记人暂未填写该信息; 国际:登记人暂未填写该信息; |
| 试验完成日期 | 国内:2018-06-30; 国际:2018-12-20; |
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