Quizartinib在治疗未达到满足的AML人群中的3期临床试验

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试验详情
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试验详情

一、临床试验项目名称
Quizartinib在治疗未达到满足的AML人群中的3期临床试验

二、适应症
初诊的FMS样酪氨酸激酶3（FLT3）基因内部串联重复（ITD）阳性（+）的急性髓系白血病（AML）

三、试验介绍

主要目的：比较Quizartinib与安慰剂对新诊断FLT3-ITD（+）AML受试者的无事件生存期（EFS）的有效性。
关键次要目的：比较Quizartinib与安慰剂治疗受试者的下列指标：总生存期（OS）、完全缓解（CR）率、复合完全缓解率（CRc =CR 血小板不完全恢复的CR[CRp]+中性粒细胞不完全恢复的CR[CRi]）、诱导化疗后，达到无最小残余疾病（MRD）的CR的受试者百分比。

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
中国医学科学院血液病医院（血液学研究所）	王建祥,硕士

序号	机构名称	主要研究者	国家	省（州）	城市
1	中国医学科学院血液病医院（血液学研究所）	王建祥	中国	天津市	天津市
2	天津医科大学总医院	邵宗鸿	中国	天津市	天津市
3	中国人民解放军总医院	于力	中国	北京市	北京市
4	山西医科大学第二医院	王梅芳	中国	山西省	太原市
5	中南大学湘雅医院	何群	中国	湖南省	长沙市
6	北京大学第三医院	克晓燕	中国	北京市	北京市
7	四川大学华西医院	吴俣	中国	四川省	成都市
8	上海长海医院	王健民	中国	上海市	上海市
9	北京大学第一医院	任汉云	中国	北京市	北京市
10	西安交通大学第一附属医院	张梅	中国	陕西省	西安市
11	中国人民解放军第三0七医院(军事医学科学院附属医院)	郭梅	中国	北京市	北京市
12	中国人民解放军第四军医大学唐都医院	刘利	中国	陕西省	西安市
13	上海交通大学医学院附属瑞金医院	李军民	中国	上海市	上海市
14	北京协和医院	李剑	中国	北京市	北京市
15	苏州大学附属第一医院	仇惠英	中国	江苏省	苏州市
16	江苏省人民医院	朱雨	中国	江苏省	南京市
17	福建医科大学附属协和医院	胡建达	中国	福建省	福州市
18	华中科技大学同济医学院附属同济医院	周剑峰	中国	湖北省	武汉市
19	兰州大学第二医院	张连生	中国	甘肃省	兰州市
20	温州医科大学附属第一医院	俞康	中国	浙江省	温州市
21	南方医科大学南方医院	刘启发	中国	广东省	广州市
22	广东省人民医院	杜欣	中国	广东省	广州市
23	中国医科大学附属第一医院	李艳	中国	辽宁省	沈阳市
24	吉林大学第一医院	高素君	中国	吉林省	长春市
25	河南省肿瘤医院	朱兴虎	中国	河南省	郑州市
26	中国医科大学附属盛京医院	刘卓刚	中国	辽宁省	沈阳市
27	浙江大学医学院附属第二医院	张晓红	中国	上海市	上海市
28	北京医院	刘辉	中国	北京市	北京市
29	北京大学国际医院	江滨	中国	北京市	北京市
30	Sanatorio Allende	Jarchum, Gustavo	Argentina	Cordoba	Cordoba
31	Sanatorio Britanico	Cerana, Susana	Argentina	Rosario	Rosario
32	Hospital Privado	García, Pablo Andrés	Argentina	Cordoba	Cordoba
33	Princess Alexandra Hospital	Marlton, Paula	Australia	QLD	Woolloongabba
34	Townsville Hospital (TTH)	Hodges, Georgina	Australia	QLD	Douglas
35	Fiona Stanley Hospital	Cannell, Paul	Australia	WA	Perth
36	Calvary Mater Newcastle	Enjeti, Anoop	Australia	NSW	Waratah
37	AZ Sint-Jan Brugge-Oostende AV	Selleslag, Dominik	Belgium	VWV	Brugge
38	UCL Mont-Godinne	Graux, Carlos	Belgium	WNA	Yvoir
39	Universitair Ziekenhuis Gent	Moors, Ine	Belgium	VOV	Gent
40	University Clinical Centre of the Republic of Srpska - Paprikovac	Hotic Lazarevic, Sandra	Bosnia And Herzegovina	Srp	Banjaluka
41	Hospital de Clínicas de Porto Alegre	Fogliatto, Laura	Brazil	RS	Porto Alegre
42	Hospital Amaral Carvalho	Mattos, Ederson	Brazil	SP	Jau
43	Centro de Pesquisas Oncologicas - CEPON	Bortolini, Jaisson	Brazil	SC	Florianopolis
44	Instituto do Cancer do Estado de Sao Paulo	Rocha, Vanderson	Brazil	SP	Sao Paulo
45	Santa Casa de Misericórdia de Porto Alegre	Escovar, Carlos Eugenio Santiago	Brazil	RS	Sao Paulo
46	Hospital da Cidade de Passo Fundo	De Almeida, Denise Ramos	Brazil	RS	Passo Fundo
47	Hospital Universitário Walter Cantídio	Duarte, Fernando	Brazil	CE	Fortaleza
48	Instituto Nacional de Cancer	Ramires Aragao, Jordana	Brazil	RJ	Rio De Janeiro
49	Hospital das Clínicas da Universidade Federal de Goias	Tavares, Renato	Brazil	GO	Goiania
50	University Multiprofile Hospital for Active Treatment	Tzvetkov, Nikolay	Bulgaria	Pleven	Pleven
51	University Multiprofile Hospital for Active Treatment	Graklanov, Vasko	Bulgaria	Plovdiv	Plovdiv
52	University of Alberta Hospital	Brandwein, Joseph	Canada	AB	Edmonton
53	Princess Margaret Cancer Centre	Minden, Mark	Canada	ON	Toronto
54	Vancouver General Hospital (VGH)	Hogge, Donna	Canada	BC	Vancouver
55	Tom Baker Cancer Centre	Geddes, Michelle	Canada	AB	Calgary
56	Klinicka Bolnica Dubrava	Pejsa, Vlatko	Croatia	Zagreb	Zagreb
57	Klinicka Bolnica Merkur	Ostojic, Slobodanka	Croatia	Zagreb	Zagreb
58	Klinicki Bolnicki Centar Zagreb	Vrhovac, Radovan	Croatia	Zagreb	Zagreb
59	Fakultní Nemocnice Ostrava	Hajek, Roman	Czech Republic	MO	Ostrava-Poruba
60	Fakultní Nemocnice Olomouc	Szotkowski, Tomas	Czech Republic	OL	Olomouc
61	Fakultní Nemocnice Hradec Králové	Zak, Pavel	Czech Republic	KR	Hradec Kralove
62	Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)	Vydra, Jan	Czech Republic	PR	Praha
63	Fakultni Nemocnice Plzen	Jindra, Pavel	Czech Republic	PL	Plzen
64	Tartu University Hospital	Kaare, Ain	Estonia	Tartu	Tartu
65	H？pital de la Conception	Costello, Régis	France	Marseille	Marseille
66	Centre Léon Bérard	Belhabri, Amine	France	Lyon	Lyon
67	Centre Hospitalier du Mans	Laribi, Kamel	France	Le Mans	Le Mans
68	L'Institut Paoli - Calmettes	Vey, Norbert	France	Marseille	Marseille
69	H？pital Haut-Lévêque	Pigneux, Arnaud	France	Pessac	Pessac
70	H？pital Saint-Louis	Dombret, Herve	France	Paris	Paris
71	Centre Hospitalier Régional Universitaire de Lille (CHRU) - H？pital Claude Huriez	Quesnel, Bruno	France	Lille	Lille
72	Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon	Bulabois, Claude-Eric	France	Grenoble	Grenoble
73	H？pital Saint-Antoine	Legrand, Olliver	France	Paris	Paris
74	Centre Henri Becquerel - Centre de Lutte Contre le Cancer	Lemasle, Emilie	France	Rouen	Rouen
75	Centre Hospitalier Lyon-Sud	Thomas, Xavier	France	Pierre Benite	Pierre Benite
76	Centre Hospitalier Universitaire de Toulouse - H？pital Purpan	Recher, Christian	France	Toulouse	Toulouse
77	Centre Hospitalier de Versailles - H？pital André Mignot	Rousselot, Philippe	France	Le Chesnay	Le Chesnay
78	CHU Limoges	Turlure, Pascal	France	Limoges	Limoges
79	CHRU Montpellier - Saint Eloi	Vincent, Laure	France	Montpellier	Montpellier
80	H？pital Avicenne	Braun, Thorsten	France	Bobigny	Bobigny
81	CHU H？pital Sud	Joris, Magalie	France	Amiens	Amiens
82	Stauferklinikum Schw？bisch Gmünd	Hebart, Holger	Germany	BW	Mutlangen
83	Evangelisches Krankenhaus Hamm gGmbH	Lange, Elisabeth	Germany	NW	Hamm
84	Universit？tsklinikum Heidelberg	Kr？mer, Alwin	Germany	BW	Heidelberg
85	Universit？tsklinikum Frankfurt	Steffen, Bj？rn	Germany	HE	Frankfurt am Main
86	Universit？tsklinikum Essen	Noppeney, Richard	Germany	NW	Essen
87	Universit？tsklinikum Hamburg-Eppendorf (UKE)	Fiedler, Walter	Germany	HH	Hamburg
88	St？dtisches Klinikum Braunschweig gGmbH	Krauter, Juergen	Germany	NI	Braunschweig
89	Universit？tsmedizin der Johannes Gutenberg-Universit？t Mainz	Radsak, Markus	Germany	RP	Mainz
90	Universit？tsklinikum Halle (Saale)	Wass, Maxi	Germany	NW	Halle
91	Universit？tsklinikum Tübingen	Schittenhelm, Marcus	Germany	BW	Tuebingen
92	Marien Hospital Düsseldorf GmbH	Giagounidis, Aristoteles	Germany	NW	Duesseldorf
93	Universit？tsklinikum Münster	Mikesch, Jan-Henrik	Germany	NW	Muenster
94	Medizinische Hochschule Hannover (MHH)	Thol, Felicitas	Germany	NI	Hannover
95	HELIOS Klinikum Wuppertal	Ragahvachar, Aruna	Germany	NW	Wuppertal
96	HELIOS Klinikum Bad Saarow	Sch？ndube, Daniel	Germany	BB	Bad Saarow
97	Universit？tsklinikum Leipzig	Schwind, Sebastian	Germany	SN	Leipzig
98	Charité - Universit？tsmedizin Berlin	Rieger, Kathrin	Germany	BE	Berlin
99	Prince of Wales Hospital	Wong, Raymond	中国	Hong Kong	Shatin
100	Queen Mary Hospital	Leung, Yu Hung	中国	Hong Kong	Hong Kong
101	Debreceni Egyetem Klinikai K？zpont	Illes, Arpad	Hungary	HB	Debrecen
102	Pecsi Tudomanyegyetem Klinikai K？zpont	Nagy, Agnes	Hungary	BA	Pecs
103	Szegedi Tudományegyetem	Borbenyi, Zita	Hungary	Csongrád	Szeged
104	Markusovszky Egyetemi Oktatókórház	Ivanyi, Janos Laszlo	Hungary	VA	Szombathely
105	Semmelweis Egyetem	Demeter, Judit	Hungary	BU	Budapest
106	The Chaim Sheba Medical Center	Nagler, Arnon	Israel	TA	Ramat Gan
107	Assaf Harofeh Medical Center	Koren-Michowitz, Maya	Israel	M	Zrifin
108	Tel Aviv Sourasky Medical Center	Ram, Ron	Israel	TA	Tel Aviv-Yafo
109	Rambam Medical Center	Ofran, Yishai	Israel	HA	Haifa
110	Bnai Zion Medical Center	Gino-Moor, Sharon	Israel	HA	Haifa
111	Rabin Medical Center - Beilinson Hospital	Wolach, Ofir	Israel	M	Petah Tiqva
112	Hadassah University Medical Center	Lavie, David	Israel	JM	Jerusalem
113	A.O.R.N.	Ferrara, Felicetto	Italy	NA	Napoli
114	Azienda Ospedaliero-Universitaria Careggi	Bosi, Alberto	Italy	FI	Firenze
115	Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari	Specchia, Giorgina	Italy	BA	Bari
116	Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara	Petrini, Mario	Italy	PI	Pisa
117	Ospedale S. Eugenio	de Fabritiis, Paolo	Italy	RM	Roma
118	IRCCS Ospedale San Raffaele	Ciceri, Fabio	Italy	MI	Milano
119	Azienda Ospedaliera Universitaria	Pane, Fabrizio	Italy	NA	Napoli
120	A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia	Candoni, Anna	Italy	UD	Udine
121	Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello	Fabbiano, Francesco	Italy	PA	Palermo
122	Azienda Ospedaliero - Universitaria San Luigi Gonzaga	Cilloni, Daniela	Italy	TO	Orbassano
123	ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese	Passamonti, Francesco	Italy	VA	Varese
124	Fondazione Policlinico Universitario Agostino Gemelli	Sica, Simona	Italy	RM	Roma
125	Azienda Ospedaliera Universitaria Senese	Bocchia, Monica	Italy	SI	Siena
126	Policlinico Tor Vergata	Venditti, Adriano	Italy	RM	Roma
127	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette	Audisio, Ernesta	Italy	TOM	Torino
128	Azienda Ospedaliero Universitaria Maggiore della Carità di Novara	Lunghi, Monia	Italy	NO	Novara
129	ASST Grande Ospedale Metropolitano Niguarda	Cairoli, Roberto	Italy	MI	Milano
130	Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo	Depaoli, Lorella	Italy	AL	Alessandria
131	Ospedale Policlinico San Martino	Beltrami, Germana	Italy	GE	Genova
132	Azienda Ospedaliera Ordine Mauriziano di Torino	Cignetti, Alessandro	Italy	TO	Torino
133	Ospedale S. Maria delle Croci - Ravenna	Lanza, Francesco	Italy	RA	Ravenna
134	Istituto Clinico Humanitas	Della Porta, Matteo Giovanni	Italy	MI	Rozzano
135	Azienda Sanitaria Locale 13 - Ospedale	Galieni, Piero	Italy	AP	Ascoli Piceno
136	Fondazione IRCCS Policlinico San Matteo	Zappasodi, Patrizia	Italy	PV	Pavia
137	Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona	Selleri, Carmine	Italy	SA	Salerno
138	Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi	Paolini, Stefania	Italy	BO	Bologna
139	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS	Giannini, Maria	Italy	FC	Meldola
140	Ospedale Infermi di Rimini	Mianulli, Anna	Italy	RN	Rimini
141	Azienda Ospedaliero-Universitaria di Parma	Prezioso, Lucia	Italy	PR	Parma
142	National Hospital Organization Nagoya Medical Center	Iida, Hiroatsu	Japan	Nagoya-Shi	Nagoya-Shi
143	Chugoku Central Hospital	Kiguchi, Toru	Japan	Fukuyama-Shi	Fukuyama-Shi
144	National Hospital Organization Kyushu Cancer Center	Choi, Ilseung	Japan	Fukuyama-Shi	Fukuyama-Shi
145	NTT Medical Center Tokyo	Usuki, Kensuke	Japan	Shinagawa-Ku	Shinagawa-Ku
146	Nagasaki University Hospital	Hata, Tomoko	Japan	Nagasaki-Shi	Nagasaki-Shi
147	Akita University Hospital	Fujishima, Naohito	Japan	Akita-Shi	Akita-Shi
148	Yokohama City University Hospital	Nakajima, Hideaki	Japan	Yokohama-Shi	Yokohama-Shi
149	Gunmaken Saiseikai Maebashi Hospital	Sakura, Toru	Japan	Maebashi-shi	Maebashi-shi
150	Sapporo Hokuyu Hospital	Ota, Shuichi	Japan	Hokkaido	Sapporo-Shi
151	Tohoku University Hospital	Ichikawa, Satoshi	Japan	Sendai-shi	Sendai-shi
152	Nagoya University Hospital	Kiyoi, Hitoshi	Japan	Nagoya-Shi	Nagoya-Shi
153	The Jikei University Hospital	Saito, Takeshi	Japan	Tokyo	Minato-Ku
154	Kameda Medical Center - Kameda General Hospital	Matsue, Kosei	Japan	Chiba	Kamogawa-Shi
155	Chiba Aoba Municipal Hospital	Yokota, Akira	Japan	Chiba	Chiba-Shi
156	University of Fukui Hospital	Yamauchi, Takahiro	Japan	Yoshida-Gun	Yoshida-Gun
157	Gifu Municipal Hospital	Takahashi, Takeshi	Japan	Gifu-Shi	Gifu-Shi
158	Kyushu University Hospital	Miyamoto, Toshihiro	Japan	Fukuoka-Shi	Fukuoka-Shi
159	Kobe City Medical Center General Hospital	Ishikawa, Takayuki	Japan	Kobe-Shi	Kobe-Shi
160	Tenri Hospital	Ohno, Hitoshi	Japan	Tenri-Shi	Tenri-Shi
161	Hamamatsu University Hospital	Ono, Takaaki	Japan	Hamamatsu-Shi	Hamamatsu-Shi
162	Gunma University Hospital	Handa, Hiroshi	Japan	Maebashi-Shi	Maebashi-Shi
163	Toyohashi Municipal Hospital	Sugiura, Isamu	Japan	Toyohashi-Shi	Toyohashi-Shi
164	National Hospital Organization Kumamoto Medical Center	Hidaka, Michihiro	Japan	Kumamoto-Shi	Kumamoto-Shi
165	Aomori Prefectural Central Hospital	Kubo, Kohmei	Japan	Aomori-Shi	Aomori-Shi
166	National Hospital Organization Kagoshima Medical Center	Otsuka, Maki	Japan	Kagoshima-Shi	Kagoshima-Shi
167	National Hospital Organization Sendai Medical Center	Meguro, Kuniaki	Japan	Miyagi	Sendai-Shi
168	Osaka Red Cross Hospital	Kaneko, Hitomi	Japan	Osaka-Shi	Osaka-Shi
169	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Najima, Yuho	Japan	Bunkyo-Ku	Bunkyo-Ku
170	Ehime Prefectural Central Hospital	Nawa, Yuichiro	Japan	Matsuyama-Shi	Matsuyama-Shi
171	Osaka City General Hospital	Yamane, Takahisa	Japan	Osaka-Shi	Osaka-Shi
172	Seoul National University Hospital	Yoon, Sung-Soo	Korea, South	Seoul	Seoul
173	Kyungpook National University Hospital	Sohn, Sang Kyun	Korea, South	Daegu	Daegu
174	The Catholic University of Korea, Seoul St. Mary's Hospital	Kim, Hee-Je	Korea, South	Seoul	Seoul
175	Severance Hospital	Min, Yoo Hong	Korea, South	Seoul	Seoul
176	Seoul National University Bundang Hospital	Lee, Jeong-Ok	Korea, South	Seongnam-si	Seongnam-si
177	Asan Medical Center	Lee, Kyoo-Hyung	Korea, South	Seoul	Seoul
178	Pusan National University Hospital	Shin, Ho-Jin	Korea, South	Seogu	Seogu
179	Korea University Guro Hospital	Choi, Chul-Won	Korea, South	Seoul	Seoul
180	Chonnam National University Hwasun Hospital	Kim, Hyeoung-Joon	Korea, South	Hwasun-gun	Hwasun-gun
181	Samsung Medical Center	Jung, Chul-Won	Korea, South	Seoul	Seoul
182	Konkuk University Medical Center	Lee, Hong Ghi	Korea, South	Seoul	Seoul
183	Ajou University Hospital	Jeong, Seong Hyun	Korea, South	Suwon	Suwon
184	SoonChunHyang University Seoul Hospital	Won, Jong Ho	Korea, South	Seoul	Seoul
185	Daegu Catholic University Medical Center	Bae, Sung-Hwa	Korea, South	Daegu	Daegu
186	Gachon University Gil Hospital	Park, Jinny	Korea, South	Namdong-Gu	Namdong-Gu
187	Inje University Haeundae Paik Hospital	Lim, Sung-Nam	Korea, South	Haeundae-gu	Haeundae-gu
188	Yeungnam University Medical Center	Kim, MinKyoung	Korea, South	Daegu	Daegu
189	Ulsan University Hospital (UUH)	Choi, Yunsuk	Korea, South	Donggu	Donggu
190	Instytut Hematologii i Transfuzjologii	Warzocha, Krzysztof	Poland	MZ	Warszawa
191	Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka	Homenda, Wojciech	Poland	PM	Slupsk
192	Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wroclawiu	Wrobel, Tomasz	Poland	DS	Wroclaw
193	Szpital Uniwersytecki w Krakowie	Skotnicki, Aleksander	Poland	MA	Kraków
194	Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António	Coutinho, Jorge	Portugal	Porto	Porto
195	Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos	Botelho de Sousa, Aida	Portugal	Lisboa	Lisboa
196	Centro Hospitalar de S？o Jo？o, EPE - Hospital de S？o Jo？o	Pinto, Ricardo	Portugal	Porto	Porto
197	Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra	Crisóstomo, Ana	Portugal	Coimbra	Coimbra
198	Instituto Português Oncologia do Porto Francisco Gentil, EPE	Martins, Angelo	Portugal	Porto	Porto
199	Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria	Vasconcelos Esteves, Graca	Portugal	Lisboa	Lisboa
200	Institutul Oncologic	Dima, Delia-Monica	Romania	CJ	Cluj-Napoca
201	Spitalul Clinic Coltea	Borsaru, Gabriela	Romania	B	Bucuresti
202	Institutul Regional de Oncologie Ia?i	Danaila, Catalin-Doru	Romania	IS	Iasi
203	Spitalul Clinic Judetean de Urgenta T？rgu - Mures	Benedek, Istvan	Romania	MS	Targu Mure
204	Spitalul Clinic Colentina	Popov, Viola-Maria	Romania	B	Bucuresti
205	Spitalul Universitar de Urgenta Bucuresti	Bumbea, Horia	Romania	B	Bucuresti
206	Spitalul Clinic Judetean de Urgenta T？rgu - Mures	Macarie, Ioan	Romania	MS	Tirgu-Mures
207	Spitalul Clinic Municipal Filantropia Craiova	Ocroteala, Luminita	Romania	Dolj	Craiova
208	Institutul Clinic Fundeni	Coriu, Daniel	Romania	B	Bucureti
209	Penza Regional Oncology Dispensary	Chagorova, Tatiana	Russian Federation	PNZ	Penza
210	Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko	Samoilova, Olga	Russian Federation	KR	Petrozavodsk
211	Tula Regional Clinical Hospital	Volodicheva, Elena	Russian Federation	TUL	Tula
212	Republican hospital named after V.A. Baranova	Myasnikov, Alexandr	Russian Federation	KR	Petrozavodsk
213	Federal Almazov Medical Research Centre	Salogub, Galina	Russian Federation	SPE	Sankt-Peterburg
214	Leningrad Regional Clinic and Hospital	Uspenskaya, Olga	Russian Federation	SPE	Sankt-Peterburg
215	Ryazan Regional Clinical Hospital	Pristupa, Alexander	Russian Federation	RYA	Ryazan
216	Russian Research Institute of Hematology and Blood Transfusion	Gritsaev, Sergey	Russian Federation	SPE	Sankt-Peterburg
217	Saratov State Medical University named after V.I. Razumovsky	Shelekhova, Tatiana	Russian Federation	SAR	Saratov
218	FSBIS	Minaeva, Natalia	Russian Federation	KIR	Kirov
219	Military Medical Academy	Stamatovic, Dragana	Serbia	Belgrade	Belgrade
220	Klinicki Centar Ni？	Macukanovic-Golubovic, Lana	Serbia	Nis	Nis
221	Klinicki Centar Srbije	Vidovic, Ana	Serbia	Belgrade	Belgrade
222	Klinicki Centar Vojvodine	Savic, Aleksandar	Serbia	Novi Sad	Novi Sad
223	National University Hospital (S) Pte Ltd	Koh, Liang Piu	Singapore	Singapore	Singapore
224	Singapore General Hospital	Lao, Zhentang	Singapore	Singapore	Singapore
225	Hospital Universitari Son Espases	Sampol Mayol, Antonia	Spain	Mallorca	Mallorca
226	Hospital Universitario Virgen del Rocío	Perez Simón, Jose Antonio	Spain	Sevilla	Sevilla
227	Hospital Clinic i Provincial	Esteve, Jordi	Spain	Barcelona	Barcelona
228	Catalan Institute of Oncology (ICO)	Vives-Polo, Susana	Spain	Barcelona	Barcelona
229	Hospital Universitari i Politècnic La Fe	Montesinos, Pau	Spain	Valencia	Valencia
230	Hospital Quirón Madrid	Martinez Chamorro, Carmen	Spain	Madrid	Madrid
231	Hospital Clinico Universitario de Valencia	Tormo, Mar	Spain	Valencia	Valencia
232	Complejo Hospitalario de Navarra	Ardaiz, Maria Angeles	Spain	Pamplona	Pamplona
233	Hospital Regional Universitario de Málaga - Hospital General	Barrios, Manuel	Spain	Málaga	Málaga
234	Hospital Universitario Marqués de Valdecilla	Colorado, Maria de las Mercedes	Spain	Santander	Santander
235	Hospital Universitario Fundacion Jimenez Diaz	Lopez Lorenzo, José Luis	Spain	Madrid	Madrid
236	Hospital General Universitario Gregorio Mara？ón	Rodriguez-Macias, Gabriela	Spain	Madrid	Madrid
237	Hosp Universitario Salamanca	Vidriales, Maria-Belen	Spain	Salamanca	Salamanca
238	Hospital Universitario Vall d'Hebron	Salamero, Olga	Spain	Barcelona	Barcelona
239	Hospital San Pedro de Alcántara	Bergua Burgues, Juan M.	Spain	Cáceres	Cáceres
240	Complejo Hospitalario Universitario Granada	Romero Aguilar, Antonio	Spain	Granada	Granada
241	Hospital Universitario Miguel Servet	Costilla Barriga, Lissette	Spain	Zaragoza	Zaragoza
242	Hospital Universitario Reina Sofía	Serrano, Josefina	Spain	Córdoba	Córdoba
243	Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario	Pérez Encinas, Manuel	Spain	Santiago de Compostela	Santiago de Compostela
244	Hospital Universitario 12 de Octubre	Martinez-Sanchez, Maria del Pilar	Spain	Madrid	Madrid
245	Hospital de Basurto	Rodriguez Gutierrez, Juan Ignacio	Spain	Bilbao	Bilbao
246	Complejo Hospitalario Universitario de Albacete - Hospital General Universitario	Algarra Algarra, Lorenzo	Spain	Albacete	Albacete
247	Hospital Universitario Ramón y Cajal	Herrera, Pilar	Spain	Madrid	Madrid
248	Hospital álvaro Cunqueiro	Suarez, Sandra	Spain	Vigo	Vigo
249	Hospital General Universitario Morales Meseguer	Amigo, MLuz	Spain	Murcia	Murcia
250	Hospital Duran i Reynals	Arnan, Montserrat	Spain	Barcelona	Barcelona
251	Hospital Universitario de Gran Canaria Doctor Negrín	Jimenez Bravo de Laguna, Santiago	Spain	Las Palmas de Gran Canaria	Las Palmas de Gran Canaria
252	Hospital Clínico Universitario	Olave, Maite	Spain	Zaragoza	Zaragoza
253	Hospital Universitario Puerta de Hierro - Majadahonda	Bautista, Guiomar	Spain	Majadahonda	Majadahonda
254	Hospital del Mar	Pedro Olive, Carmen	Spain	Barcelona	Barcelona
255	Hospital Universitari Joan XXIII de Tarragona	Cervera, Marta	Spain	Tarragona	Tarragona
256	Hospital Universitario Central de Asturias	Bernal, Teresa	Spain	Oviedo	Oviedo
257	Hospital Universitario Dr. Peset	Sayas, Maria	Spain	Valencia	Valencia
258	Hospital Clínico San Carlos	Polo, Marta	Spain	MADRID	MADRID
259	Hospital General Universitario de Alicante	Gil Cortes, Cristina	Spain	Alicante	Alicante
260	Complexo Hospitalario Universitario A Coru？a	Noriega Concepcion, Victor	Spain	La Coruna	La Coruna
261	Hospital Universitari de Girona Doctor Josep Trueta	Coll Jorda, Rosa	Spain	Girona	Girona
262	National Cheng Kung University Hospital	Chen, Tsai-Yun	中国	Taiwan	Tainan
263	China Medical University Hospital	Yeh, Su-Peng	中国	Taiwan	Taichung
264	Taipei Veterans General Hospital	Gau, Jyh-Pyng	中国	Taiwan	Taipei
265	National Taiwan University Hospital	Ko, Bor-Sheng	中国	Taiwan	Taipei
266	Chang Gung Medical Foundation - Kaohsiung Branch	Kuo, Ching-Yuan	中国	Taiwan	Kao-Hsiung
267	Chang Gung Medical Foundation - Linkou Branch	Wang, Po-Nan	中国	Taiwan	Taoyuan
268	Cherkassy Regional Oncology Center	Pylypenko, Galyna	Ukraine	Cherkasy	Cherkasy
269	Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho	Skrypnyk, Igor	Ukraine	Poltava	Poltava
270	Zhitomir Regional Clinical Hospital	Lysa, Tamila	Ukraine	Zhytomyr	Zhytomyr
271	Vinnitsa Regional Clinical Hospital im. N.I. Pirogov	Oliynyk, Hanna	Ukraine	Vinnytsia	Vinnytsia
272	East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital	Pocock, Chris	United Kingdom	KEN	Canterbury
273	Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital	Dimitriadou, Evangelia	United Kingdom	KEN	Maidstone
274	West Virginia University Hospitals, Inc.	Craig, Michael	United States	WV	Morgantown
275	The University of Chicago Medical Center	Larson, Richard	United States	IL	Chicago
276	Rush University Medical Center	Larson, Melissa	United States	IL	Chicago
277	Hudson Valley Hematology Oncology Associates	Seiter, Karen	United States	NY	Valhalla
278	Hospital of the University of Pennsylvania	Perl, Alexander	United States	PA	Philadelphia
279	University of Florida (UF) Health Shands Hospital	Hsu, Jack	United States	FL	Gainesville
280	Thomas Jefferson University Hospital	Kasner, Margaret	United States	PA	Philadelphia
281	University of Kentucky Albert B. Chandler Hospital	Hildebrandt, Gerhard	United States	KY	Lexington
282	Duke Clinical Research Institute	de Castro, Carlos	United States	NC	Durham
283	John Theurer Cancer Center at Hackensack University Medical Center	Koprivnikar, Jamie	United States	NJ	Hackensack
284	University Hospitals Seidman Cancer Center	Cooper, Brenda	United States	OH	Cleveland
285	Franciscan St. Francis Health Indianapolis	Tandra, Anand	United States	IN	Indianapolis

1	实施任何研究规定的操作或试验前，有能力并且能够理解、签署伦理委员会或机构审查委员会批准的知情同意书（ICF）并注明日期；
2	≥18岁或达到法定成人年龄（以较高者为准）和≤75岁（筛选期）；
3	基于世界卫生组织（WHO）2008分类（筛选期），患有形态学新诊断的原发性AML或者继发于骨髓增生异常综合征或骨髓增生性肿瘤的AML；
4	东部肿瘤协作组体能状态0～2（筛选期）；
5	骨髓中存在FLT3-ITD激活突变（FLT3-ITD/总FLT3的等位基因比例≥3%）；
6	如方案中规定，受试者接受标准 “7+3” 诱导化疗治疗方案；
7	肾功能规定：a. 按改良的Cockcroft Gault等式计算的肌酐清除率>50 mL/min；
8	肝功规定： a. 总血清胆红素 ≤ 1.5 × ULN； b. 血清碱性磷酸酶、天冬氨酸转氨酶和丙氨酸转氨酶 ≤2.5 × ULN；
9	血清电解质在正常限值内：钾、钙（总值或在低白蛋白血症情况下，为血清白蛋白校正值）和镁。若超出正常限度，电解质纠正后受试者才有资格入选；
10	如果为有生育能力的女性，则必须在进入本研究时接受血清妊娠检测且结果为阴性，且必须愿意在入组后、治疗期间和研究药物或阿糖胞苷末次用药后6个月期间（以后到者为准）使用高效避孕措施。除非永久丧失生育能力（接受过子宫切除、双侧输卵管切除术或双侧卵巢切除术），否则从初潮直到开始绝经（最少停经12个月）的女性均被视为有生育能力的女性；
11	如为男性，则必须接受过绝育手术或者愿意在入组后、治疗期间和研究药物或阿糖胞苷末次用药后6个月期间（以后到者为准）使用高效避孕措施。

1	诊断患有急性早幼粒细胞白血病（APL），法国-美国-英国分类M3型或WHO分类的APL，并表现为t（15；17）（q22；q12）染色体易位，或BCR-ABL阳性白血病（即慢性粒细胞白血病原始细胞危象）；接受了APL诊断检查和全反式维甲酸（ATRA）治疗，但未发现APL的受试者符合入选资格（必须在开始诱导化疗前停止ATRA治疗）。
2	诊断患有继发于其它肿瘤既往化疗或放疗的AML；
3	以下为允许的AML既往治疗： a. 白细胞去除术； b. 使用羟基脲治疗高白细胞血症； c.颅放射治疗中枢神经系统（CNS）白细胞淤滞症； d. 预防性鞘内化疗； e. 生长因子/细胞因子支持疗法；
4	既往接受过Quizartinib或其它FLT3-ITD抑制剂治疗；
5	随机入组前30天既往接受过任何新药或器械治疗（研究性或经批准的免疫治疗2周内）或仍正在参与其他研究治疗；
6	有CNS白血病史，包括脑脊液AML原始细胞呈阳性；建议有CNS白血病症状的受试者行腰穿以排除中枢神经系统受累的髓外病变；
7	其它恶性肿瘤病史，充分治疗的非黑色素瘤皮肤癌、治愈的原位疾病或治愈的至少2年内无疾病迹象的其他实体瘤除外；
8	无法控制或显著的心血管疾病，包括下列任一情况：a. 心动过缓，每分钟心跳小于50，使用起搏器的受试者除外； b. QTcF间期>450 msec；c. 诊断或疑似患有长QT综合征（包括有长QT综合征家族史）； d. 收缩压 ≥ 180 mmHg或舒张压 ≥ 110 mmHg；e. 有临床意义的室性心律失常病史（如室性心动过速，室颤或尖端扭转型室性心动过速）； f. 有二度（Mobitz II）或三度心脏传导阻滞病史（若使用起搏器时无昏厥或具有临床意义的心律失常病史，使用起搏器的受试者有资格入选）； g. 筛选前6个月内具有无法控制的心绞痛或心肌梗死病史；h. 有纽约心脏病学会3类或4类的心力衰竭病史； i. 有左心室射血分数（LVEF）≤45%或小于正常标准下限的病史； j. 完全性左束支传导阻滞；
9	有抗真菌、抗菌性或抗病毒治疗未达到充分控制的活动性急性或慢性真菌、细菌或病毒感染；
10	有活动性具有临床意义的肝病（如活动性乙肝或活动性丙肝）
11	有人免疫缺陷病毒（HIV）感染病史。若当地法规或EC要求，随机入组前受试者应检查HIV；
12	有对Quizartinib/安慰剂片中任一辅料过敏史；
13	妊娠或哺乳期妇女；
14	研究者认为不适合入选研究的其他方面。

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