天津达沙替尼III期临床试验-达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究

登记号	CTR20131054	试验状态	已完成
申请人联系人	汪涛	首次公示信息日期	2014-04-02
申请人名称	百时美施贵宝（中国）投资有限公司/ Bristol-Myers Squibb Company

登记号	CTR20131054
相关登记号	暂无
药物名称	达沙替尼
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	新诊断的成人慢性期慢性髓性白血病患者
试验专业题目	比较达沙替尼和伊马替尼治疗新诊断的慢性髓细胞白血病慢性期受试者的随机、多中心、开放性3 期临床研究
试验通俗题目	达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究
试验方案编号	CA180-056	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

申请人名称	1 2
联系人姓名	汪涛	联系人座机	010-65632538	联系人手机号	暂无
联系人Email	Tao.wang4@bms.com	联系人邮政地址	北京市朝阳区建外大街永安里甲16号CBD国际大厦18层	联系人邮编	100022

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。

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

年龄	18岁(最小年龄)至 105岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	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
排除标准	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

试验药	序号 名称 用法 1 中文通用名:达沙替尼 用法用量:100mg口服，一天一次 2 中文通用名:达沙替尼 用法用量:片剂；规格50mg；口服，一天一次，每次100mg，连续用药共计5年（或连续给药直至疾病进展或发生不可接受的毒性）。
对照药	序号 名称 用法 1 中文通用名:伊马替尼 用法用量:片剂；规格100mg；口服，一天一次，每次400mg，连续用药共计5年（或连续给药直至疾病进展或发生不可接受的毒性）。 2 中文通用名:伊马替尼 用法用量:400mg口服，一天一次

主要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 治疗12 个月内经确认最佳的完全细胞遗传学缓解率 每3个月 有效性指标
次要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 12个月内CCyR的发生时间和到CCyR的时间 治疗12个月内，每3个月一次。以后每12个月一次。 有效性指标 2 确认的 CCyR 的发生时间和到确认的CCyR 的时间 治疗12个月内，每3个月一次。以后每12个月一次。 有效性指标

1	姓名	王建祥	学位	暂无	职称	主任医师
	电话	022-23909120	Email	wangjx@ihcams.ac.cn	邮政地址	天津市南京路288号
	邮编	300020	单位名称	中国医学科学院血液病医院

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

序号	名称	审查结论	批准日期/备案日期
1	中国医学科学院血液病医院伦理委员会	t	2008-09-10
2	中国医学科学院血液病医院伦理委员会	同意	2008-09-10
3	福建医科大学附属协和医院伦理委员会	同意	2008-09-25

已完成

目标入组人数	国内: 37 ； 国际: 550 ；
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: 37  ； 国际: 519 ；

第一例受试者签署知情同意书日期	国内：2008-11-14；     国际：登记人暂未填写该信息；
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：2014-01-15；     国际：登记人暂未填写该信息；