登记号
CTR20244780
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
急性髓系白血病
试验通俗题目
奎扎替尼或安慰剂联合化疗治疗新诊断的FLT3-ITD 阴性AML 患者
试验专业题目
一项在新诊断的FLT3-ITD 阴性急性髓系白血病成人患者中评价奎扎替尼联合诱导和巩固化疗以及奎扎替尼作为维持治疗的III 期、双盲、随机、安慰剂对照试验（QuANTUM-Wild）
试验方案编号
AC220-168
方案最近版本号
3.0
版本日期
2024-08-08
方案是否为联合用药
否
申请人信息
申请人名称
联系人姓名
印飞
联系人座机
021-60397718
联系人手机号
联系人Email
yin.fei.v4@daiichisankyo.com.cn
联系人邮政地址
上海市-上海市-南京西路1717号会德丰国际广场52层
联系人邮编
200040
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
本研究是一项在新诊断的FMS样酪氨酸激酶3（FLT3）-内部串联重复（ITD）阴性急性髓系白血病（AML）成人患者中比较奎扎替尼与安慰剂（联合标准诱导和巩固化疗，然后作为维持治疗持续给药最多36个周期）对主要终点总生存期（OS）的作用的III期、国际多中心、双盲、随机、安慰剂对照试验。
患者的FLT3-ITD突变状态将在中心实验室使用经验证的检测方法检测。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
70岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 在进行任何试验特定程序或检查之前，必须有能力并能够理解、签署伦理委员会（EC）或机构审查委员会（IRB）批准的知情同意书（ICF）并注明日期。
- ≥18 岁或最低法定成年年龄（以较大者为准）且≤70 岁（筛选时）。
- 根据世界卫生组织（WHO）2016 年分类，受试者被新诊断为原发性AML 并经形态学证实（筛选时）
- 美国东部肿瘤协作组（ECOG）体能状态评分（受试者签署ICF 时）为0-2 分。
- 受试者正在接受方案中规定的标准“7+3”诱导化疗方案
排除标准
- 诊断为急性早幼粒细胞白血病（APL）、法国-美国-英国分型中的M3 型或WHO分型中的APL 伴易位t(15;17)(q22;q12)或BCR-ABL阳性白血病（即慢性髓性白血病急变期）；接受了APL 诊断检查和全反式维甲酸（ATRA）治疗但未发现患有APL 的受试者有研究入选资格（在开始诱导化疗前必须终止ATRA 治疗）。
- 诊断为继发于既往化疗或放疗（用于治疗其他肿瘤或自身免疫/风湿病）的AML。
- 诊断为继发于骨髓异常增生综合征（MDS）或骨髓增殖性肿瘤（MPN）或MDS/MPN（包括CMML、aCML、JMML 和其他）的AML。
- 新诊断为AML 且FLT3-ITD 突变（FLT3-ITD[+]）的VAF≥5%（或SR≥0.05）（基于经验证的FLT3 突变检测）。
- 既往接受过AML 治疗，以下允许情况除外： a. 白细胞去除术； b. 使用羟基脲治疗白细胞过多； c. 中枢神经系统（CNS）白细胞淤滞的颅脑放射疗法； d. 预防性鞘内化疗； e. 生长因子/细胞因子支持疗法。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:奎扎替尼
|
剂型:片剂
|
|
中文通用名:奎扎替尼
|
剂型:片剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
剂型:片剂
|
|
中文通用名:安慰剂
|
剂型:片剂
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 总生存期（OS） | 从随机化日期至全因死亡日期的时间 ，约42个月 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 无事件生存期（EFS） | 首例受试者随机化后约42个月 | 有效性指标 |
| 完全缓解持续时间（DoCR） | 首例受试者随机化后约42个月 | 有效性指标 |
| 无复发生存期（RFS） | 首例受试者随机化后约42个月 | 有效性指标 |
| 完全缓解率（CR） | 诱导治疗结束时，约120天 | 有效性指标 |
| CR且微小或可测量残留病灶（MRD）阴性 | 诱导治疗结束时（第1周期，或第1周期和第2周期）和2个周期结束时（2个诱导治疗周期或1个诱导治疗周期和1个巩固治疗周期） | 有效性指标 |
| 试验期间的TEAE和其他安全性参数 | 首次给药至试验药物末次给药，约为42个月 | 安全性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 王建祥 | 硕士 | 教授 | 86-22-23909120 | wangjx@ihcams.ac.cn | 天津市-天津市-和平区南京路288 号 | 300020 | 中国医学科学院血液病医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 中国医学科学院血液病医院 | 王建祥 | 中国 | 天津市 | 天津市 |
| 吉林大学第一医院 | 高素君 | 中国 | 吉林省 | 长春市 |
| 河南省肿瘤医院 | 魏旭东 | 中国 | 河南省 | 郑州市 |
| 青岛大学附属医院 | 赵春亭 | 中国 | 山东省 | 青岛市 |
| 北京协和医院 | 李剑 | 中国 | 北京市 | 北京市 |
| 中国医科大学附属盛京医院 | 杨威 | 中国 | 辽宁省 | 沈阳市 |
| 烟台毓璜顶医院 | 马俊杰 | 中国 | 山东省 | 烟台市 |
| 温州医科大学附属第一医院 | 俞康 | 中国 | 浙江省 | 温州市 |
| 山东大学齐鲁医院 | 纪春岩 | 中国 | 山东省 | 济南市 |
| 南通大学附属医院 | 刘红 | 中国 | 江苏省 | 南通市 |
| 无锡市人民医院 | 周新 | 中国 | 江苏省 | 无锡市 |
| 北京大学第三医院 | 景红梅 | 中国 | 北京市 | 北京市 |
| 西安交通大学第一附属医院 | 贺鹏程 | 中国 | 陕西省 | 西安市 |
| 苏州大学附属第一医院 | 仇惠英 | 中国 | 江苏省 | 苏州市 |
| 中南大学湘雅医院 | 徐雅靖 | 中国 | 湖南省 | 长沙市 |
| 南昌大学第一附属医院 | 李菲 | 中国 | 江西省 | 南昌市 |
| 广东省人民医院 | 邓程新 | 中国 | 广东省 | 广州市 |
| 中山大学肿瘤防治中心 | 梁洋 | 中国 | 广东省 | 广州市 |
| 上海市同仁医院 | 刘立根 | 中国 | 上海市 | 上海市 |
| 中南大学湘雅二医院 | 彭宏凌 | 中国 | 湖南省 | 长沙市 |
| 天津医科大学总医院 | 付蓉 | 中国 | 天津市 | 天津市 |
| 东南大学附属中大医院 | 葛峥 | 中国 | 江苏省 | 南京市 |
| 深圳市第二人民医院 | 杜新 | 中国 | 广东省 | 深圳市 |
| 重庆医科大学附属第一医院 | 罗小华 | 中国 | 重庆市 | 重庆市 |
| 北京大学第一医院 | 梁赜隐 | 中国 | 北京市 | 北京市 |
| St Vincent's Hospital Melbourne | Tan Shuhying | Australia | New South Wales | Darlinghurst |
| Royal Adelaide Hospital | Singhal Deepak | Australia | South Australia | Adelaide |
| Concord Repatriation General Hospital | Singhal Deepak Gasiorowski Robin | Australia | New South Wales | Concord |
| Townsville University Hospital | Morris Edward | Australia | Queensland | Douglas |
| Princess Alexandra Hospital | Harwood Matthew | Australia | Queensland | Woolloongabba |
| Sir Charles Gairdner Hospital | Grove Carolyn | Australia | Western Australia | Perth |
| The Alfred Hospital | Fleming Shaun | Australia | Victoria | Melbourne |
| Liverpool Hospital | Getta Bartlomiej | Australia | New South Wales | Liverpool |
| Box Hill Hospital | Ting Stephen | Australia | Victoria | Box Hill |
| Flinders Medical Centre | Beligaswatte Ashanka | Australia | South Australia | Bedford Park |
| Fiona Stanley Hospital | Cannell Paul | Australia | Western Australia | Murdoch |
| LKH - Universit？tsklinikum der PMU Salzburg | Leisch Michael | Austria | NA | Salzburg |
| AKH - Medizinische Universit？t Wien | Sperr Wolfgang | Austria | NA | Vienna |
| Ordensklinikum Linz GmbH - Elisabethinen | Machherndl-Spandl Sigrid | Austria | NA | Linz |
| LKH- Universit？tsklinik Graz | Zebisch Armin | Austria | NA | Linz |
| AZ Sint-Jan | Schauwvlieghe Alexander | Belgium | NA | Brugge |
| AZ Delta | Deeren Dries | Belgium | NA | Roeselare |
| ZNA | Breems Dimitri | Belgium | NA | Antwerpen |
| UZ Leuven | Maertens Johan | Belgium | NA | Leuven |
| CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE | De Voeght Adrien | Belgium | NA | Liege |
| Institut Jules Bordet | Wittnebel Sebastian | Belgium | NA | Anderlecht |
| Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP | Duarte Bruno | Brazil | Sao Paulo | Campinas |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Longo Buka Mariana | Brazil | Sao Paulo | Sao Jose Rio Preto |
| BP A Beneficencia Portuguesa da Sao Paulo | Lazari Jean Carlos | Brazil | Sao Paulo | S？o Paulo |
| UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Dezen Gaiolla Rafael | Brazil | Sao Paulo | Botucatu |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer | Samuel de Holanda Farias Joao | Brazil | Paraná | Curitiba |
| Hospital Nove de Julho | De Molla Vinicius | Brazil | Sao Paulo | Sao Paulo |
| Santa Casa de Misericórdia de Porto Alegre | Schneider Fraga Elisa | Brazil | Rio Grande do Sul | Porto Alegre |
| INCA - Instituto Nacional de Cancer | Ramires Aragao Jordana | Brazil | Rio de Janeiro | Rio de Janeiro |
| Hospital de Clínicas de Porto Alegre | Weber Cristiane | Brazil | Rio Grande do Sul | Porto Alegre |
| Hospital de Clínicas de Passo Fundo | Ramos de Almeida Denise | Brazil | Rio Grande do Sul | Passo Fundo |
| Funda？？o Doutor Amaral Carvalho | de Mattos Ederson Roberto | Brazil | Sao Paulo | Jaú |
| HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás | Rabelo Yana | Brazil | Goiás | Goiania |
| CEPON - Centro de Pesquisas Oncológicas de Santa Catarina | Cavalcanti Ferreira David | Brazil | Santa Catarina | Florianópolis |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Barroso Duarte Fernando | Brazil | Ceará | Fortaleza |
| ICESP - Instituto do Cancer do Estado de S？o Paulo Octavio Frias de Oliveira | Rego Eduardo | Brazil | Sao Paulo | S？o Paulo |
| UMHAT “Sv. Ivan Rilski”, EAD | Radinoff Atanas | Bulgaria | NA | Sofia |
| UMHAT Prof. Dr. Stoyan Kirkovich AD | Todorova Mariya | Bulgaria | NA | Stara Zagora |
| Military Medical Academy - MHAT - Sofia | Barbukova Viktoria | Bulgaria | NA | Sofia |
| UMHAT 'Dr. Georgi Stranski', EAD | Naneva Silvia | Bulgaria | NA | Pleven |
| UMHAT | Sapunarova Katya | Bulgaria | NA | Plovdiv |
| McGill University - Dept. Oncology Clinical Research Program | Popradi Gizelle | Canada | Quebec | Montreal |
| London Health Sciences Centre (LHSC) - Victoria Hospital | Saini Lalit | Canada | Ontario | London |
| University Health Network - Princess Margaret Cancer Centre | Schuh Andre | Canada | Ontario | Toronto |
| The Ottawa Hospital - General Campus | Sabloff Mitchell | Canada | Ontario | Ottawa |
| Clinical Hospital Dubrava | Prka Zeljko | Croatia | NA | Zagreb |
| Clinical Hospital Centre Rijeka | Peric Zinaida | Croatia | NA | Rijeka |
| University Hospital Center Zagreb | Vrhovac Radovan | Croatia | NA | Zagreb |
| Fakultni nemocnice Kralovske Vinohrady | Novak Jan | Czech Republic | NA | Praha 10 |
| Fakultni nemocnice Ostrava | Dluhosova Barbora | Czech Republic | NA | Ostrava - Poruba |
| Ustav hematologie a krevni transfuze | Valka Jan | Czech Republic | NA | Praha 2 |
| Fakultni nemocnice Brno | Mayer Jiri | Czech RepublicCzech Republic | NA | Brno |
| Fakultni nemocnice Plzen | Jindra Pavel | Czech Republic | NA | Plzen-Lochotin |
| CHU Nice - H？pital de l'Archet 1 | Cluzeau Thomas | France | Alpes Maritimes | Nice |
| CHU de Nantes - Hotel Dieu | Peterlin Pierre | France | Loire Atlantique | Nantes cedex 1 |
| CHU de Caen | Chantepie Sylvain | France | Calvados | Caen |
| Centre Leon Berard | Belhabri Amine | France | Rhone | Lyon |
| CHU Rennes - Hopital Pontchaillou | Marchand Tony | France | Ille et Vilaine | Rennes cedex 9 |
| Hopital Claude Huriez - CHRU Lille | Berthon Celine | France | Nord | Lille cedex |
| Centre Hospitalier Lyon Sud | Heiblig Mael | France | Rhone | Pierre Bénite |
| Institut Universitaire du Cancer de Toulouse- IUCT-O | Recher Christian | France | Haute Garonne | Toulouse |
| Hopital de la Conception - APHM | Costello Régis | France | Bouches-du-Rh？ne | Marseille Cedex 05 |
| CHU de Grenoble - H？pital Albert Michallon | Bulabois Claude-Eric | France | Isere | Grenoble |
| CHU Angers - H？pital H？tel Dieu | Hunault Berger Mathilde | France | Maine et Loire | Angers |
| Institut Gustave Roussy | De Botton Stephane | France | Val de Marne | Villejuif cedex |
| CHU Amiens - Hopital Sud | Lebon Delphine | France | Somme | Salouel |
| Institut de Cancérologie de Strasbourg Europe - ICANS | Ledoux Marie-Pierre | France | Bas Rhin | Strasbourg |
| H？pital Saint-Louis | Raffoux Emmanuel | France | Paris | Paris cedex 10 |
| CHU de Bordeaux - H？pital Haut-Lévêque | Dumas Pierre-Yves | France | Gironde | Pessac cedex |
| Centre Hospitalier de Versailles | Rousselot Philippe | France | Yvelines | Pessac cedex |
| Klinikum Aschaffenburg-Alzenau | Welslau Manfred | Germany | Bayern | Alzenau |
| Universitaetsklinikum Essen | Hanoun Maher | Germany | Nordrhein Westfalen | Essen |
| Universit？tsklinikum Leipzig Klinik für H？matologie Internistische Onkologie H？mostaseologische Ambu | Jentzsch Madlen | Germany | Sachsen | Leipzig |
| KRH Klinikum Siloah | Doerfel Daniela | Germany | Niedersachsen | Hannover |
| Charité Universit？tsmedizin Berlin - Campus Virchow-Klinikum | Westermann Joerg | Germany | Berlin | Berlin |
| Universitaetsklinikum Schleswig-Holstein | Sauer Tim | Germany | Schleswig Holstein | Kiel |
| Universitaetsklinikum Heidelberg | Mikesch Jan-Henrik | Germany | Baden Wuerttemberg | Heidelberg |
| Universitaetsklinikum Muenster | Krauter Juergen | Germany | Nordrhein Westfalen | Münster |
| Staedtisches Klinikum Braunschweig gGmbH | Roellig Christoph | Germany | Niedersachsen | Braunschweig |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Leung Anskar Yu Hung | Germany | Sachsen | Dresden |
| The University of Hong Kong | Leung Anskar Yu Hung | 中国香港 | NA | Hong Kong |
| The Chinese University of Hong Kong (CUHK) | Wong Raymond Siu Ming | 中国香港 | NA | Shatin |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz | Lazar Zsolt | Hungary | NA | Gyor |
| Debreceni Egyetem | Illes Arpad | Hungary | NA | Debrecen |
| Semmelweis Egyetem | Nagy Zsolt Gyorgy | Hungary | NA | Budapest |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Borbenyi Zita | Hungary | NA | Szeged |
| Istituto Clinico Humanitas | Ubezio Marta | Italy | Milano | Rozzano |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | Audisio Ernesta | Italy | Torino | Torino |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Cattaneo Chiara | Italy | Brescia | Brescia |
| Ospedale Maggiore di Novara | Lunghi Monia | Italy | Novara | Novara |
| ASST dei Sette Laghi Ospedale di Circolo e Fondazione Macchi Varese | Basilico Claudia Maria | Italy | Varese | Varese |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Venditti Adriano | Italy | Roma | Rome |
| Ospedale San Raffaele | Ciceri Fabio | Italy | Milano | Milano |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Musto Pellegrino | Italy | Bari | Bari |
| IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori | Giannini Maria Benedetta | Italy | Forli - Cesena | Meldola |
| Ospedale Mauriziano Umberto I | Cilloni Daniela | Italy | Torino | Torino |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Sica Simona | Italy | Roma | Rome |
| Azienda Ospedaliera Vincenzo Cervello | Mulè Antonino | Italy | Palermo | Palermo |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Cairoli Roberto | Italy | Milano | Milano |
| IRCCS Ospedale Casa Sollievo della Sofferenza | Carella Michele | Italy | Foggia | San Giovanni Rotondo |
| Chiba Aoba Municipal Hospital | Yokota Akira | Japan | Chiba-Ken | Chiba-shi |
| Kyushu University Hospital | Kikushige Yoshikane | Japan | Fukuoka-Ken | Fukuoka-shi |
| Nagoya University Hospital | Ishikawa Yuichi | Japan | Aichi-Ken | Nagoya-shi |
| Hamamatsu University School of Medicine, University Hospital | Nagata Yasuyuki | Japan | Shizuoka-Ken | Hamamatsu-shi |
| Hokkaido University Hospital | Onozawa Masahiro | Japan | Hokkaido | Sapporo-shi |
| Gifu Municipal Hospital | Kasahara Senji | Japan | Gifu-Ken | Gifu-shi |
| Kanazawa University Hospital | Miyamoto Toshihiro | Japan | Ishikawa-Ken | Kanazawa-shi |
| Tenri Hospital | Akasaka Takashi | Japan | Nara-Ken | Tenri-shi |
| Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Najima Yuho | Japan | Tokyo-To | Bunkyo-ku |
| Ehime Prefectural Central Hospital | Nawa Yuichiro | Japan | Ehime-Ken | Matsuyama-shi |
| Aomori Prefectural Central Hospital | Kubo Komei | Japan | Aomori-Ken | Aomori-shi |
| Saiseikai Maebashi Hospital | Takada Satoru | Japan | Gunma-Ken | Maebashi-shi |
| Chugoku Central Hospital | Makita Masanori | Japan | Hiroshima-Ken | Fukuyama-shi |
| Tesshokai Kameda General Hospital | Matsue Kosei | Japan | Chiba-Ken | Kamogawa-shi |
| Osaka Red Cross Hospital | Imada Kazunori | Japan | Osaka-Fu | Osaka-shi |
| NHO Kumamoto Medical Center | Kawakita Toshiro | Japan | Kumamoto-Ken | Kumamoto-shi |
| Hokuyukai Sapporo Hokuyu Hospital | Ota Shuichi | Japan | Hokkaido | Sapporo-shi |
| Akita University Hospital | Kobayashi Takahiro | Japan | Akita-Ken | Akita-shi |
| Kyungpook National University Hospital | Moon Joon Ho | Korea, Republic of South | NA | Daegu |
| Jeonbuk national university hospital | Kwak Jae-Yong | Korea, Republic of South | Jeollabuk-do | Jeonju-si |
| Ajou University Hospital | Yang Cheongin | Korea, Republic of South | Gyeonggi-do | Suwon |
| Seoul National University Bundang Hospital | Bang Soo-Mee | Korea, Republic of South | Gyeonggi-do | Seongnam |
| Seoul National University Hospital | Shin Dong-Yeop | Korea, Republic of South | NA | Seoul |
| Asan Medical Center | Lee Je-Hwan | Korea, Republic of South | NA | Seoul |
| Pusan National University Hospital | Shin Ho-Jin | Korea, Republic of South | NA | Seoul |
| Gachon University Gil Medical Center | Kim Hawk | Korea, Republic of South | NA | Busan |
| Samsung Medical Center | Jung Chul Won | Korea, Republic of South | NA | Incheon |
| Yeungnam University Hospital | Kim Min Kyoung | Korea, Republic of South | NA | Seoul |
| The Catholic University of Korea, Seoul St. Mary’s Hospital | Kim Hee-Je | Korea, Republic of South | NA | Daegu |
| Daegu Catholic University Medical Center | Bae Sung Hwa | Korea, Republic of South | NA | Seoul |
| Inje University Haeundae Paik Hospital | Lim Sung-Nam | Korea, Republic of South | NA | Daegu |
| Korea University Guro Hospital | Choi Chul Won | Korea, Republic of South | NA | Seoul |
| Chonnam National University Hwasun Hospital | Ahn Jae-Sook | Korea, Republic of South | NA | Hwasun-gun |
| Severance Hospital, Yonsei University Health System | Cheong June-Won | Korea, Republic of South | NA | Seoul |
| Ulsan University Hospital | Lee YooJin | Korea, Republic of South | NA | Ulsan |
| Oslo University Hospital | Lenartova Andrea | Norway | NA | Oslo |
| Haukeland Universitetssykehus | Gjertsen Bj？rn Tore | Norway | NA | Bergen |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu | Chraniuk Dominik | Poland | NA | Torun |
| Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie | Halka Janusz | Poland | NA | Olsztyn |
| Uniwersytecki Szpital Kliniczny nr 1 w Lublinie | Hus Marek | Poland | NA | Lublin |
| Instytut Hematologii i Transfuzjologii | Patkowska Elzbieta | Poland | NA | Warszawa |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Chacim Sergio | Portugal | NA | Porto |
| Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria | Infante Joana | Portugal | NA | Lisboa |
| Spitalul Clinic Colentina | Popescu Mihaela | Romania | NA | Bucuresti |
| Spitalul Clinic Municipal Filantropia Craiova | Ocroteala Luminita | Romania | NA | Craiova |
| Institutul Clinic Fundeni | Stancioaica Maria | Romania | NA | Bucuresti |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca | Rus Ioana Codruta | Romania | NA | Cluj-Napoca |
| Spitalul Clinic Coltea | Borsaru Gabriela | Romania | NA | Bucuresti |
| University Clinical Center Nis | Miljkovic Edita | Serbia | NA | Nis |
| University Clinical Center of Serbia | Vidovic Ana | Serbia | NA | Belgrade |
| Military Medical Academy | Atanaskovic Lavinika | Serbia | NA | Belgrade |
| Curie Oncology Pte Ltd | Loh Yvonne | Singapore | NA | Singapore |
| National University Hospital | Ooi Melissa Gaik Ming | Singapore | NA | Singapore |
| Hospital Universitario La Paz | Sanchez Vadillo Irene | Spain | Madrid | Madrid |
| Hospital Universitario de Burgos | Labrador Jorge | Spain | Burgos | Burgos |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol | Vives Polo Susana | Spain | Barcelona | Barcelona |
| Hospital Universitario de Gran Canaria Dr. Negrin | Rodriguez Medina Carlos | Spain | Las Palmas | Las Palmas de Gran Canaria |
| Hospital de la Santa Creu i Sant Pau | Garrido Diaz Ana | Spain | Barcelona | Barcelona |
| Clinica Universidad de Navarra | Alfonso Pierola Ana | Spain | Navarra | Pamplona |
| Hospital Universitario Reina Sofia | Serrano Lopez Josefina | Spain | Córdoba | Cordoba |
| Hospital Universitario Dr. Peset | Sayas Lloris Maria Jose | Spain | Valencia | Valencia |
| Hospital Universitario Ramon y Cajal | Herrera Puente Pilar | Spain | Madrid | Madrid |
| Hospital Universitario Quironsalud Madrid | Pradillo Fernandez Virginia | Spain | Madrid | Pozuelo de Alarcon |
| Hospital Universitario Virgen del Rocio | Rodriguez Arboli Eduardo | Spain | Sevilla | Sevilla |
| Hospital Universitari Vall d'Hebron | Salamero Olga | Spain | Barcelona | Barcelona |
| Hospital Universitario 12 de Octubre | Martinez Sanchez M. Pilar | Spain | Madrid | Madrid |
| Hospital Regional Universitario de Malaga | Contento Gonzalo Alejandro | Spain | Málaga | Malaga |
| Hospital Universitari Son Espases | Sampol Mayol Antonia | Spain | Baleares | Palma de Mallorca |
| Hospital Clinico Universitario de Valencia | Tormo Diaz Maria del Mar | Spain | Valencia | Valencia |
| Complejo Hospitalario Universitario de Santiago | Perez Encinas Manuel Mateo | Spain | La Coru？a | Santiago de Compostela |
| Hospital Universitari i Politecnic La Fe | Rodriguez Veiga Rebeca | Spain | Valencia | Valencia |
| Hospital San Pedro de Alcantara | Bergua Burgues Juan Miguel | Spain | Cáceres | Caceres |
| MD Anderson Cancer Centre | de la Fuente Burguera Adolfo | Spain | Madrid | Madrid |
| Hospital Clinico Universitario de Salamanca | Vidriales Vicente Maria Belen | Spain | Salamanca | Salamanca |
| Hospital Universitario Marques de Valdecilla | Colorado Araujo Mercedes | Spain | Cantabria | Santander |
| Hospital General Universitario Morales Meseguer | Amigo Maria Luz | Spain | Murcia | Murcia |
| Hospital Universitario Puerta de Hierro Majadahonda | de Miguel Jimenez Carlos | Spain | Madrid | Majadahonda |
| Complejo Hospitalario Universitario de Albacete | Algarra Jesus Lorenzo | Spain | Albacete | Albacete |
| Hospital Universitario Fundacion Jimenez Diaz | Lopez Lorenzo Jose Luis | Spain | Madrid | Madrid |
| Sahlgrenska Universitetssjukhuset | Sahlgrenska Universitetssjukhuset | Sweden | NA | G？teborg |
| Sk？nes Universitetssjukhus, Lund | Lazarevic Vladimir | Sweden | NA | Lund |
| Luzerner Kantonsspital - Luzern | Gregor Michael | Switzerland | NA | Luzern 16 |
| Inselspital - Universitaetsspital Bern | Pabst Thomas | Switzerland | NA | Bern |
| National Cheng Kung University Hospital | Chen Tsai-Yun | 中国台湾 | NA | Tainan |
| Taipei Veterans General Hospital | Liu Yao-Chung | 中国台湾 | NA | Taipei |
| National Taiwan University Hospital | Ko Bor-Sheng | 中国台湾 | NA | Taipei |
| Kaohsiung Chang Gung Memorial Hospital | Liu Hung-Lin | 中国台湾 | NA | Kaohsiung |
| Chang Gung Memorial Hospital,Linkou | Lin Tung-Liang | 中国台湾 | NA | Taoyuan City |
| China Medical University Hospital | Yeh Su-Peng | 中国台湾 | NA | Taichung |
| Torbay Hospital | Zhao Rui | United Kingdom | Devon | Torquay |
| Manchester Royal Infirmary | Tholouli Eleni | United Kingdom | Greater Manchester | Manchester |
| Hammersmith Hospital | Pavlu Jiri | United Kingdom | Greater London | London |
| Churchill Hospital | Sweeney Connor | United Kingdom | Oxfordshire | Headington |
| King's College Hospital | Shah Mili | United Kingdom | Greater London | London |
| Massachusetts General Hospital | Fathi Amir | USA | Massachusetts | Boston |
| Ohio Health Marion Area Physicians | William Basem | USA | Ohio | Columbus |
| Henry Ford Columbus Center | Mattour Ahmad | USA | Michigan | Detroit |
| Rhode Island Hospital | Reagan John | USA | Rhode Island | Providence |
| Memorial Sloan Kettering Cancer Center - MAIN | Stein Eytan | USA | New York | New York |
| The Kirklin Clinic of UAB Hospital | Vachhani Pankit | USA | Alabama | Birmingham |
| Mayo Clinic - Phoenix | Arana Yi Cecilia | USA | Arizona | Phoenix |
| Mayo Clinic | Saliba Antoine | USA | Minnesota | Rochester |
| Duke Cancer Institute- Sarcoma Research | Erba Harry | USA | North Carolina | Durham |
| South Austin Medical Center | Osman Diaa | USA | Texas | Austin |
| UCSF - School of Medicine | Ferng Timothy | USA | California | San Francisco |
| TriStar Bone Marrow Transplant | Strickland Stephen | USA | Tennessee | Fl Nashville |
| University of Arizona Cancer Center | Khurana Sharad | USA | Arizona | Tucson |
| University of Michigan Comprehensive Cancer Center Michigan Medicine | Bixby Dale | USA | Michigan | Ann Arbor |
| Roswell Park Cancer Institute | Wang Eunice | USA | New York | Buffalo |
| University of Cincinnati Medical Center | Curran Emily | USA | Ohio | Cincinatti |
| University of Minnesota Medical School - Twin Cities Campus | Premnath Naveen | USA | Minnesota | Minneapolis |
| City of Hope - Phoenix Cancer Center | Kovacsovics Tibor | USA | Arizona | Goodyear |
| Oregon Health & Science University (OHSU) | Traer Elie | USA | Oregon | Portland |
| Tampa General Hospital | Swoboda David | USA | Florida | Tampa |
| Thomas Jefferson Univ Hosp | Kasner Margaret | USA | Pennsylvania | Philadelphia |
| Upstate University Hospital | Gentile Teresa | USA | New York | Syracuse |
| University of Pennsylvania | Perl Alexander | USA | Pennsylvania | Philadelphia |
| University of Kentucky | Qasrawi Ayman | USA | Kentucky | Lexington |
| University of North Carolina Hospitals | Zeidner Joshua | USA | North Carolina | Chapel Hill |
| The University of Chicago Medical Center | Larson Richard | USA | Illinois | Chicago |
| Virginia Commonwealth University (VCU) Massey Cancer Center | Maher Keri | USA | Virginia | Richmond |
| Florida Hospital Cancer Institute - Kissimmee | Parkin Brian | USA | Florida | Kissimmee |
| Houston Methodist Hospital | Shah Shilpan | USA | Texas | Houston |
| The University of Texas MD Anderson Cancer Center | Daver Naval | USA | Texas | Houston |
| Mayo Clinic Hospital | Murthy Hemant | USA | Florida | Jacksonville |
| Peggy & Charles Stephenson Oklahoma Cancer Ctr | Pandey Manu | USA | Oklahoma | Oklahoma City |
| Colorado Blood Cancer Institute | Migdady Yazan | USA | Colorado | Denver |
| Stanford University School of Medicine- PARENT | Mannis Gabriel | USA | California | Palo Alto |
| Hackensack University Medical Center | McCloskey James | USA | New Jersey | Hackensack |
| The James Cancer Hospital and Solove Research Institute | Borate Uma | USA | Ohio | Columbus |
| Washington University, School of Medicine | Abboud Ramzi | USA | Missouri | St. Louis |
| Johns Hopkins Hospital | Levis Mark | USA | Maryland | Baltimore |
| Cleveland Clinic Taussig Cancer Center | Jain Akriti | USA | Ohio | Cleveland |
| Medical College of Wisconsin | Guru Murthy Guru Subramanian | USA | Wisconsin | Milwaukee |
| University of Illinois Hospital & Health Sciences System | Quigley John | USA | Illinois | Chicago |
| Augusta University | Cortes Jorge | USA | Georgia | Augusta |
| Yale University | Zeidan Amer | USA | Connecticut | New Haven |
| Moffit Cancer Center | Sallman David | USA | Florida | Tampa |
| SHATHD EAD Sofia | Yankova Tanya | Bulgaria | NA | Sofia |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 中国医学科学院血液病医院（中国医学科学院 血液学研究所）伦理审查委员会 | 同意 | 2024-09-26 |
试验状态信息
试验状态
进行中-尚未招募
目标入组人数
国内: 105 ；
国际: 700 ；
已入组例数
国内: 登记人暂未填写该信息；
国际: 1 ；
实际入组总例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：2024-11-19；
第一例受试者入组日期
国内：登记人暂未填写该信息；
国际：2024-11-26；
试验终止日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
