达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究

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一、临床试验项目名称
达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究

二、适应症
新诊断的成人慢性期慢性髓性白血病患者

三、试验介绍

在新诊断的慢性期Ph+ CML受试者中，比较达沙替尼和伊马替尼治疗
12个月的完全细胞遗传学缓解（CCyR）率。同时观察治疗的安全性。

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	王建祥

序号	机构名称	主要研究者	国家	省（州）	城市
1	福建协和医院		中国	福建	福州
2	中国医学科学院血液病医院	王建祥	中国	天津	天津
3	北京大学人民医院		中国	北京	北京
4	上海瑞金医院	沈志祥	中国	上海	上海
5	上海瑞金医院		中国	上海	上海
6	北京大学人民医院	黄晓军	中国	北京	北京
7	福建协和医院	胡建达	中国	福建	福州
8	Hospital Britanico	Bullorsky, Eduardo	Argentina	BUENOS AIRES	Buenos Aires
9	Hospital Italiano La Plata	Milone, Jorge	Argentina	BUENOS AIRES	La Plata
10	Hospital General De Agudos J.M. Ramos Mejia	Moiraghi, Beatriz	Argentina	BUENOS AIRES	Capital Federal
11	Fundaleu	Pavlovsky, Carolina	Argentina	BUENOS AIRES	Capital Federal
12	Royal Brisbane &Women'S Hospital	Durrant, Simon Trevor	Australia	Queensland	Brisbane
13	Royal Perth Hospital	Herrmann, Richard	Australia	Western Australia	Perth
14	Nicol, Andrew	Nicol, Andrew	Australia	Queensland	Greenslopes
15	Southern Health-Monash Medical Centre	Opat, Stephen	Australia	Victoria	Clayton
16	The Canberra Hospital	Prosser, Ian	Australia	ACT	WODEN
17	Newcastle Mater Misericordiae Hospital	Rowlings, Philip	Australia	New South Wales	Waratah
18	The Mater Private Centre For Haematology & Oncology	Taylor, Kerry	Australia	Queensland	South Brisbane
19	Universitaetsklinikum Innsbruck	Gastl, Guenther	Austria	Innsbruck	Innsbruck
20	Universitaetsklinik Salzburg	Greil, Richard	Austria	Salzburg	Salzburg
21	Klinikum Kreuzschwestern Wels	Thaler, Josef	Austria	Wels	Wels
22	Department Fuer Haematologie	Valent, Peter	Austria	Wien	Wien
23	Cliniques Universitaires Saint-Luc	Ferrant, Augustin	Belgium	Bruxelles	Bruxelles
24	Az Sint-Jan	Van Droogenbroeck, Jan	Belgium	Brugge	Brugge
25	Santa Casa De Misericordia De Sao Paulo	Chiattone, Carlos Sergio	Brazil	Sao Paulo	Sao Paulo
26	Fundacao Hospital Amaral Carvalho	Colturato, Vergílio	Brazil	Sao Paulo	Jau
27	Universidade Estadual De Campinas	De Souza, Carmino	Brazil	Sao Paulo	Campinas
28	Hospital Das Clinicas - Fundacao Pro-Sangue - Hemocentro	Dorlhiac Llacer, Pedro E	Brazil	Sao Paulo	Sao Paulo
29	Hospital Das Clínicas De Ribeir？o Preto	Falc？o, Roberto Passeto	Brazil	Sao Paulo	Ribeir？o Preto
30	Instituto Nacional De Cancer	Moellmann-Coelho, Arthur	Brazil	Rio De Janeiro	Rio De Janeiro
31	Hosp Clin Univ Fed Do Parana	Pasquini, Ricardo	Brazil	Parana	Curitiba
32	Hospital Das Clínicas De Porto Alegre - Ufrs	Silva, Lucia Mariano	Brazil	Rio Grande Do Sul	Porto Alegre
33	Hospital Brigadeiro	Zanichelli, Maria Aparecida	Brazil	Sao Paulo	Sao Paulo
34	Oncomed	Orlandi, Francisco	Chile	METROPOLITANA	Santiago
35	Hospital Del Salvador	Undurraga, Maria Soledad	Chile	METROPOLITANA	Santiago
36	Instituto Nacional De Cancerologia	Enciso, Leonardo	Colombia	Bogota	Bogota
37	Clinica Colombia	Ramirez, Carlos	Colombia	Bogota	Bogota
38	Fakultni Nemocnice Olomouc	Faber, Edgar	Czech Republic	Olomouc	Olomouc
39	Ustav Hematologie A Krevni Transfuze	Klamova, Hana	Czech Republic	Prague 2	Prague 2
40	University Hospital	Mayer, Jiri	Czech Republic	Brno - Bohunice	Brno - Bohunice
41	Fakultni Nemocnice Hradec Kralove	Voglova, Jaroslava	Czech Republic	Hradec Kralove	Hradec Kralove
42	Aalborg Univ Hosp	Helleberg Rasmussen, Inge	Denmark	Aalborg	Aalborg
43	Odense University Hospital	Marcher, Claus	Denmark	Odense	Odense
44	Aarhus University Hospital	Stentoft, Jesper	Denmark	Aarhus C	Aarhus C
45	Hopital Morvan	Berthou, Christian	France	Brest Cedex 02	Brest Cedex 02
46	Chu Dupuytren	Bordessoule, Dominique	France	Limoges	Limoges
47	Institut Paoli-Calmettes	Charbonnier, Aude	France	Marseille Cedex 9	Marseille Cedex 9
48	Hotel Dieu - Chu De Nantes	Dubruille, Viviane	France	Na	Nantes Cedex 1
49	Chu Pontchaillou	Escoffre-Barbe, Martine	France	Rennes	Rennes
50	Centre Hospitalier Regional Et Universitaire De Lille	Facon, Thierry	France	Lille Cedex	Lille Cedex
51	C H R U De Nancy Hopital De Brabois	Guerci-Bresler, Agnes	France	Vandoeuvre Les Nancy	Vandoeuvre Les Nancy
52	Centre Investigation Clinique	Guilhot, Francois	France	Poitiers Cedex	Poitiers Cedex
53	Hopital Civil	Herbrecht, Raoul	France	Na	Strasbourg
54	Chu Purpan - Hopital Casselardit	Huguet, Francoise	France	Toulouse Cedex 09	Toulouse Cedex 09
55	Hopital Necker	Lefrere, Francois	France	Paris	Paris
56	Centre Hospitalier Lyon Sud	Michallet, Mauricette	France	Pierre Benite Cedex	Pierre Benite Cedex
57	Hopital Saint Eloi	Quittet, Philippe	France	Na	Montpellier Cedex 5
58	Hopital Saint Louis	Rea, Delphine	France	Na	Paris Cedex 10
59	Medizinische Hochschule Hannover	Ganser, Arnold	Germany	Hannover	Hannover
60	Universitaet Rostock Med Fakultaet	Junghanss, Christian	Germany	Rostock	Rostock
61	Campus Virchow Klinikum Der Charite	Le Coutre, Philipp	Germany	Berlin	Berlin
62	Med. Klinik 2	Soekler, Martin	Germany	Tuebingen	Tuebingen
63	Universitaetsklinikum Ulm	Stegelmann, Frank	Germany	Ulm	Ulm
64	Medizinische Universitaetsklinik Freiburg	Waller, Cornelius	Germany	Freiburg	Freiburg
65	General Peripheral Hospital George Papanikolaou	Anagnostopoulos, Achilleas	Greece	Thessaloniki	Thessaloniki
66	General Hospital Gennimatas	Anagnostopoulos, Nikolaos	Greece	Athens	Athens
67	General Hospital Of Athens Evangelismos	Nikiforakis, Emmanuel	Greece	Athens	Athens
68	University Of Pecs	David, Mariann	Hungary	Pecs	Pecs
69	Fovarosi Egyesitett Szent Istvan Es Szent Laszlo Korhaz Es R	Fekete, Sandor	Hungary	Budapest	Budapest
70	Fovarosi Egyesitett Szent Istvan Es Szent Laszlo Korhaz Es R	Masszi, Tamas	Hungary	Budapest	Budapest
71	Semmelweis Korhaz 2 Belgyogyaszat Es Haematologia	Radvanyi, Gaspar	Hungary	Miskolc	Miskolc
72	Debreceni Egyetem Orvos-és Egészségtudományi Centrum	Udvardy, Miklos	Hungary	Debrecen	Debrecen
73	Hematology Clinic	Agarwal, Usha	India	Mumbai	Mumbai
74	Lakeshore Hospital & Research Centre Ltd	Gangadharan, V . P	India	Cochin	Cochin
75	All India Institute Of Medical Sciences	Kumar, Rajat	India	New Delhi	New Delhi
76	Christian Medical College	Mathews, Vikram	India	Vellore	Tamilnadu
77	Regional Cancer Centre	Narayanan, Geetha	India	Trivandrum	Trivandrum
78	Tata Memorial Hospital	Prabhash, Kumar	India	Mumbai	Mumbai
79	Prince Aly Khan Hospital	Saikia, Tapan	India	Mumbai	Mumbai
80	Vedanta Institute Of Medical Sciences	Shah, Sandip	India	Ahmedabad	Ahmedabad
81	Ospedale S.Eugenio	Abruzzese, Elisabetta	Italy	Roma	Roma
82	Universita' Degli Studi Sapienza Di Roma	Alimena, Giuliana	Italy	Rome	Rome
83	Azienda Ospedaliera Universitaria Careggi	Bosi, Alberto	Italy	Firenze	Firenze
84	Universita' Di Bologna	Cavo, Michele	Italy	Bologna	Bologna
85	Ospedale Ferrarotto	Di Raimondo, Francesco	Italy	Catania	Catania
86	Azienda Ospedaliera San Gerardo	Gambacorti-Passerini, Carlo	Italy	Monza (mb)	Monza (mb)
87	Ospedale Policlinico Consorziale	Liso, Vincenzo	Italy	Bari	Bari
88	Ospedale Niguarda Ca'Granda	Morra, Enrica	Italy	Milano	Milano
89	Irccs Policlinico S Matteo	Orlandi, Ester Maria	Italy	Pavia	Pavia
90	Azienda Ospedaliera San Luigi Gonzaga	Saglio, Giuseppe	Italy	Orbassano (to)	Orbassano (to)
91	Yokohama City University Medical Center	Fujisawa, Shin	Japan	KANAGAWA	Yokohama
92	Iwate Medical University Hospital	Ishida, Yoji	Japan	IWATE	Morioka-shi
93	Tohoku University Hospital	Ishizawa, Kenichi	Japan	Miyagi	Sendai-City
94	Saitama Medical Center, Jichi Medical University	Kanda, Yoshinobu	Japan	SAITAMA	Saitama
95	Kameda Clinic Of Medical Corporation Tesshokai	Matsue, Kosei	Japan	CHIBA	Kamogawa-shi
96	Osaka City University Hospital	Nakamae, Hirohisa	Japan	OSAKA	Osaka-shi
97	Tokyo Metropolitan Komagome Hospital	Ohashi, Kazuteru	Japan	TOKYO	Bunkyo-ku
98	Fukuoka University Hospital	Tamura, Kazuo	Japan	FUKUOKA	Fukuoka
99	Okayama University Hospital	Tanimoto, Mitsune	Japan	OKAYAMA	Okayama-shi
100	University Hospital Kyoto Prefectural University Of Medicine	Taniwaki, Masafumi	Japan	KYOTO	Kyoto-shi
101	Nagoya Daini Red Cross Hospital	Uchida, Toshiki	Japan	AICHI	Nagoya
102	Ntt Medical Center Tokyo	Usuki, Kensuke	Japan	TOKYO	Shinagawa-ku
103	Imamura Bun-In Hospital	Utsunomiya, Atae	Japan	KAGOSHIMA	Kagoshima-shi
104	Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.	Aguayo Gonzalez, Alvaro	Mexico	Distrito Federal	Delegacion Tlalpan
105	Centro Medico Nacional La Raza	Ayala Sanchez, Jose Luis Manuel	Mexico	Distrito Federal	Mexico
106	Instituto Nacional De Cancerologia	Cervera, Eduardo	Mexico	Distrito Federal	Mexico City
107	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Gomez Almaguer, David	Mexico	Nuevo Leon	Monterrey
108	Clinica N°25 Imss	Hernandez Valdes, Roberto	Mexico	Nuevo Leon	Monterrey
109	Hospital General De Mexico	Kassack Ipina, Juan Julio	Mexico	Distrito Federal	Mexico, D. F.
110	Centro Medico Nacional Siglo Xxi	Meillon Garcia, Luis Antonio	Mexico	Distrito Federal	Mexico, D. F.
111	Hospital General De Culiacan Dr. Bernardo J. Gastelum	Rivas Llamas, Ramon	Mexico	Sinaloa	Culiacan
112	Umc Nijmegen	Schattenberg, A.V.M.B	Netherlands	Nijmegen	Nijmegen
113	Umc Groningen	Vellenga, Edo	Netherlands	Groningen	Groningen
114	Instituto Nacional De Enfermedades Neoplasicas	Casanova, Luis	Peru	Lima	Lima
115	Hospital Nacional Alberto Seguin -Essalud Arequipa	Malaga Zenteno, Jose	Peru	Arequipa	Arequipa
116	Hospital Nacional Edgardo Rebagliati Martins	Navarro, Juan	Peru	Lima	Lima
117	Zespot Szpitali Miejskich	Grosicki, Sebastian	Poland	Chorzow	Chorzow
118	Odz. Hematologii I Chorob Rozrostowych Ukl.Krwiotworczego	Komarnicki, Mieczyslaw	Poland	Poznan	Poznan
119	Klinika Hematologii Um W Lodzi, Woj.Szpital Spec	Robak, Tadeusz	Poland	Lodz	Lodz
120	Oddzial Kliniczny Kliniki Hematologii	Skotnicki, Aleksander	Poland	Krakow	Krakow
121	Klinika Hematologii Instytutu Hematologii I Transfuzjologii	Warzocha, Krzysztof	Poland	Warsaw	Warsaw
122	The Catholic University Of Korea , Seoul St. Mary'S Hospital	Kim, Dong-Wook	Republic of Korea	Seoul	Seoul
123	Asan Medical Center	Lee, Kyoo-Hyung	Republic of Korea	Seoul	Seoul
124	Spitalul Clinic Coltea Clinica De Hematologie	Anca Roxana, Lupu	Romania	Bucuresti	Bucuresti
125	Spitalul Municipal De Urgenta Timisoara Clinica De Hematolog	Ionita, Hortensia Marioara	Romania	Timisoara	Timisoara
126	Institutul Oncologic Ioan Chiricuta Clinica De Hematologie	Petrov, Liubomir	Romania	Cluj Napoca	Cluj Napoca
127	Institutul Clinic Fundeni Centrul De Hematologie	Stoia, Razvan	Romania	Bucuresti	Bucuresti
128	Russian Research Institute Of Hematology And Transfusiology	Abdylkadirov, Kudrat	Russian Federation	Saint-petersburg	Saint-petersburg
129	Moscow Region Research Clinical Institute	Golenkov, Anatoly	Russian Federation	Moscow	Moscow
130	National Research Hematology Center	Khoroshko, Nina	Russian Federation	Moscow	Moscow
131	Novosibirsk State Medical University	Pospelova, Tatiana	Russian Federation	Novosibirsk	Novosibirsk
132	Rostov State Medical University	Shatokhin, Yuri	Russian Federation	Rostov-on-don	Rostov-on-don
133	St.Pet State Medical University Named Afteri.P Pavlov	Zaritskey, Andrey Yu	Russian Federation	St.petersburg	St.petersburg
134	Hospital Del Mar	Alvarez, Alberto	Spain	Barcelona	Barcelona
135	Instituto Catalan De Oncologia	Boque, Concepcion	Spain	Barcelona	Barcelona
136	Hospital Clinic I Provincial	Cervantes, Francisco	Spain	Barcelona	Barcelona
137	Hospital Universitario La Paz	De Paz, Raquel	Spain	Madrid	Madrid
138	Hospital Universitario De Salamanca	Del Canizo, Consuelo	Spain	Salamanca	Salamanca
139	Hospital Carlos Haya De Malaga	Jimenez-Velasco, Antonio	Spain	Malaga	Malaga
140	Hospital Universitario Y Politecnico La Fe	Martinez-Dominguez, Jesus	Spain	Valencia	Valencia
141	Hospital Son Dureta	Novo, Andres	Spain	Palma De Mallorca	Palma De Mallorca
142	Comp. H. U. De Santiago	Perez, Manuel	Spain	Santiago De Compostela	Santiago De Compostela
143	Hosp Univ Virgen Macarena	Portero, Mari Angeles	Spain	Sevilla	Sevilla
144	Hospital General De Asturias	Ramirez Payer, Angel	Spain	Oviedo	Oviedo
145	Hospital Universitario De La Princesa	Steegmann, Juan Luis	Spain	Madrid	Madrid
146	Erciyes Universitesi Tip Fakultesi	Cetin, Mustafa	Turkey	Kayseri	Kayseri
147	Osmangazi Universitesi Tip Fakultesi	Gulbas, Zafer	Turkey	Eskisehir	Eskisehir
148	Hacettepe Universitesi Tip Fakultesi	Haznedaroglu, Ibrahim C	Turkey	Ankara	Ankara
149	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Soysal, Teoman	Turkey	Istanbul	Istanbul
150	Singapore General Hospital	Chuah, Charles Thuan Heng	Singapore	Singapore	Singapore

1	年龄≥18 岁男性和女性
2	年龄≥18 岁男性和女性
3	ECOG 体力状态 0-2
4	慢性期费城染色体阳性慢性髓细胞白血病
5	慢性期费城染色体阳性慢性髓细胞白血病
6	ECOG 体力状态 0-2

1	胸腔积液
2	胸腔积液
3	未得到控制的心血管疾病
4	既往接收过干扰素、伊马替尼、达沙替尼或抗CML全身治疗，阿那格雷和羟基脲除外
5	与慢性髓细胞白血病无关的严重出血性疾病
6	与慢性髓细胞白血病无关的严重出血性疾病
7	既往接收过干扰素、伊马替尼、达沙替尼或抗CML全身治疗，阿那格雷和羟基脲除外
8	未得到控制的心血管疾病

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