天津注射用卡非佐米III期临床试验-一项关于初诊的不符合移植条件的多发性骨髓瘤临床研究

登记号	CTR20140135	试验状态	进行中
申请人联系人	段若竹	首次公示信息日期	2014-05-19
申请人名称	Onyx Pharmaceuticals, Inc./ DSM Pharmaceuticals,Inc.(DPI)/ 杭州泰格医药科技股份有限公司

登记号	CTR20140135
相关登记号	暂无
药物名称	注射用卡非佐米
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	初诊的不符合移植条件的多发性骨髓瘤
试验专业题目	一项对比CMP疗法与VMP疗法用于初诊的不符合移植条件的多发性骨髓瘤患者的随机、开放、Ⅲ期临床研究
试验通俗题目	一项关于初诊的不符合移植条件的多发性骨髓瘤临床研究
试验方案编号	2012-005	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 3
联系人姓名	段若竹	联系人座机	010-65997954	联系人手机号	暂无
联系人Email	tduan@amgen.com	联系人邮政地址	北京市朝阳区光华路1号嘉里中心写字楼北楼11层1121	联系人邮编	100006

主要目的：比较初诊的不符合移植条件的多发性骨髓瘤的受试者接受CMP方案与接受VMP方案治疗的无进展生存期。 次要目的：对比治疗组间的总生存期、完全缓解率、总缓解率、疗效持续时间、神经病变事件、健康相关生活质量评分、安全性与耐受性。

试验分类	安全性和有效性	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 N/A岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	1 初诊的有症状的多发性骨髓瘤（根据国际骨髓瘤工作组 [IMWG]诊断标准） 2 不符合移植条件 3 可测量疾病，定义为以下一项或多项（随机化前21天内进行评估）： 血清M蛋白 ≥ 0.5 g/dL，或 尿M蛋白 ≥ 200 mg/24小时，或 在检测不到血清或尿M蛋白的受试者中，血清游离轻链（SFLC）> 100 mg/L （涉及的轻链） 且κ/λ比率异常（SFLC κ/λ比率 1.65） 4 既往未接受过多发性骨髓瘤治疗 5 年龄≥ 18岁的男性和女性 6 美国东部肿瘤协作组（ECOG）体能状态评分0–2分 7 随机化前21天内有足够的肝功能，其中胆红素 8 中性粒细胞绝对值（ANC）≥ 1.0 × 109/L 9 随机化前21天内血红蛋白（Hgb）≥ 8.0 g/dL。 依据机构指导原则，允许使用红细胞刺激因子和红细胞（RBC）输注 10 血小板计数 ≥ 50 × 109/L 11 随机化前21天内计算或测量的肌酐清除率（CrCl） ≥ 15 mL/min。 根据Cockcroft和Gault公式进行计算： [（140 – 年龄）？ 体重（kg）/（72 ？ 肌酐 mg/dL）]；若为女性，则结果乘以0.85。 12 左心室射血分数（LVEF）≥ 40%； 2D经胸超声心动图（ECHO）是一种首选评价方法； 若无法获得ECHO，则可接受多门探测扫描（MUGA） 13 随机化前21天内，育龄期女性（FCBP）必须确认血清妊娠试验为阴性（在中心实验室进行）并同意在所有研究药物使用期间以及最后一次给药后6个月内采用高效避孕措施，即当连续和正确使用这些避孕措施时失败率较低的节育方法（即每年低于1%）。如果当地法规要求，可采取更频繁的妊娠试验。本方案中FCBP定义为性成熟女性：1）未经历子宫切除术或双侧卵巢切除术，或2）自然停经未持续连续的24个月（癌症治疗后闭经不排除有生育能力）（即，在之前连续的24 个月内的任何时间出现了月经）。 14 如果在研究期间和所有研究药物最后一次给药后6个月内，男性受试者与育龄女性发生性行为，则必须采取有效的屏障避孕措施 15 根据联邦、当地和机构指导原则的要求填写书面知情同意书
排除标准	1 IgM（免疫球蛋白M）亚型的多发性骨髓瘤 2 随机化前14天内的糖皮质激素治疗累积剂量等于或超出160mg地塞米松 3 POEMS综合征（多发性神经病变、器官肿大、内分泌病变、单克隆免疫球蛋白血症和皮肤改变） 4 浆细胞白血病（外周血浆细胞> 2.0 × 109/L） 5 Waldenstrom巨球蛋白血症（WM） 6 已知的淀粉样变性 7 随机化前7天内接受过局部放射治疗 8 随机化前21天内接受过任何免疫疗法 9 随机化前21天内接受过大手术 10 随机化前6个月内出现过充血性心力衰竭（纽约心脏病学会 [NYHA]心功能III级至IV级）、 症状性心肌缺血、不能通过传统干预治疗控制的传导异常、急性弥散性浸润型肺部疾病、心包病变或心肌梗死 11 随机化前14天内有活动性感染 12 已知的人类免疫缺陷病毒（HIV）血清反应阳性、丙型肝炎感染和/或乙型肝炎（允许正在接受乙肝抗病毒治疗且对该治疗有应答的乙肝表面抗原[SAg]阳性或核心抗体阳性的受试者入选） 13 已知有肝硬化 14 过去5年中出现继发性恶性肿瘤，除以下外： 充分治疗的基底细胞或鳞状细胞皮肤癌， 宫颈原位癌，或 前列腺癌Gleason评分＜6，且12个月以上检测不到前列腺特异性抗原（PSA） 手术完全切除的乳腺导管原位癌（即，组织边缘未发现乳癌细胞），或 经治疗的甲状腺髓样癌或乳头状癌，或 预期5年无疾病生存率＞95%的类似疾病 15 骨髓增生异常综合征 16 随机化前14天内显著精神病变（等级≥2） 17 受试者为妊娠或哺乳期女性 18 已知的Captisol过敏史（用于溶解卡非佐米的环糊精衍生物） 19 对硼或甘露醇（与硼替佐米给药相关）具有超敏反应 20 对美法仑或所有爱克兰辅料具有超敏反应 21 强的松/地塞米松禁忌症 22 必需的伴随用药或支持性治疗禁忌症，包括对抗病毒药物的超敏反应或由于原有肺部或心脏损伤造成的水化治疗不耐受 23 需进行胸腔穿刺术的胸腔积液 24 需进行穿刺术的腹水 25 未控制的高血压或未控制的糖尿病 26 研究者认为可影响方案依从性或影响受试者签署知情同意书的具有临床意义的任何其他内科疾病或状况

试验药	序号 名称 用法 1 中文通用名:注射用卡非佐米 用法用量:注射剂；规格60mg/瓶；第1周期的第1、2天静脉给予卡非佐米20mg/m2，给药时间应在30分钟±5分钟。第1周期的第8、9、22、23、29和30天增加至36mg/m2，给药时间为30分钟±5分钟。第2-9周期的第1、2、8、9、22、23、29和30天静脉给予卡非佐米36mg/m2。 2 中文通用名:美法仑片 用法用量:片剂；规格2mg；口服，每个周期第1天和第2天给予卡非佐米前至少30分钟（但是不超过4小时）以及每个周期的第3天和第4天的上午服用美法仑，每次9mg/m2。 3 中文通用名:强的松片 用法用量:片剂；规格5mg、20mg、50mg；口服，在每个周期第1天和第2天给予卡非佐米前至少30分钟（但是不超过4小时）以及每个周期第3天和第4天上午服用强的松，每次60mg/m2。
对照药	序号 名称 用法 1 中文通用名:注射用硼替佐米英文名：BortezomibforInjection商品名：万珂 用法用量:注射剂；规格3.5mg/瓶；1.3mg/m2静脉注射或皮下注射将在第1-4周期的第1、4、8、11、22、25、29和32天以及第5-9周期的第1、8、22和29天进行。 2 中文通用名:美法仑片 用法用量:片剂；规格2mg；口服，在每个周期第1天和第4天给予硼替佐米前至少30分钟（但是不超过4小时）以及每个周期的第2天和第3天上午服用美法仑，每次9mg/m2。 3 中文通用名:强的松片 用法用量:片剂；规格5mg、20mg、50mg；口服，在每个周期第1天和第4天给予硼替佐米前至少30分钟（但是不超过4小时）以及每个周期的第2天和第3天上午服用强的松，每次60mg/m2。

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 无进展生存期（PFS） 在开始治疗的前54周每3周对受试者缓解进行一次评估，随后每6周进行一次，直至确认PD、受试者撤回进一步参与的知情同意、失访、死亡或研究关闭，以先发生者为准。 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 总生存期 治疗期及时报告；受试者出现PD后，将进行每12周一次的长期生存随访直至受试者撤回进一步参与的知情同意、失访、死亡或申办者决定关闭研究。 有效性指标 2 完全缓解状况 在开始治疗的前54周每3周对受试者缓解进行一次评估，随后每6周进行一次，直至确认PD、受试者撤回进一步参与的知情同意、失访、死亡或研究关闭，以先发生者为准。 有效性指标 3 总体缓解状况 在开始治疗的前54周每3周对受试者缓解进行一次评估，随后每6周进行一次，直至确认PD、受试者撤回进一步参与的知情同意、失访、死亡或研究关闭，以先发生者为准。 有效性指标 4 缓解持续时间 在开始治疗的前54周每3周对受试者缓解进行一次评估，随后每6周进行一次，直至确认PD、受试者撤回进一步参与的知情同意、失访、死亡或研究关闭，以先发生者为准。 有效性指标 5 神经病变事件 每周期第一天及治疗结束访视，之后每6周一次直到疾病进展 安全性指标 6 使用EORTC QLQC30 全球健康状况量表测定的HRQoL较基线变化 每周期第一天及治疗结束访视，之后每6周一次直到疾病进展 有效性指标+安全性指标 7 安全性与耐受性 在受试者签署知情同意书（ICF）后开展并将持续至所有研究药物最后一次给药后30天 安全性指标

1	姓名	邱录贵，医学博士	学位	暂无	职称	教授
	电话	022-23909172	Email	drqiu99@medmail.com.cn	邮政地址	天津市和平区南京路288号
	邮编	300041	单位名称	中国医学科学院血液学研究所血液病医院

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学研究所血液病医院	邱录贵	中国	天津市	天津市
2	吉林大学第一医院	李薇	中国	吉林省	长春市
3	北京协和医院	周道斌	中国	北京市	北京市
4	上海交通大学医学院附属瑞金医院	沈志祥	中国	上海市	上海市
5	北京朝阳医院	陈文明	中国	北京市	北京市
6	苏州大学附属第一医院	傅铮铮	中国	江苏省	苏州市
7	北京大学第三医院	克晓燕	中国	北京市	北京市
8	福建医科大学附属协和医院	刘庭波	中国	福建省	福州市
9	西京医院	陈协群	中国	陕西省	西安市
10	上海长海医院	王健民	中国	上海市	上海市
11	中国人民解放军三〇七医院	陈虎	中国	北京市	北京市
12	四川大学华西医院	刘霆	中国	四川省	成都市
13	中山大学附属肿瘤医院	吕跃	中国	广东省	广州市
14	天津医科大学肿瘤医院	张翼鷟	中国	天津市	天津市
15	广州市第一人民医院	王顺青	中国	广东省	广州市
16	浙江大学医学院附属第一医院	金洁	中国	浙江省	杭州市
17	广东省人民医院	杜欣	中国	广东省	广州市
18	CEMIC	Riveros, Dardo	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
19	COIR Fundacion Centro Oncologico de Integracion Regional	Viudez, Maria Laura	Argentina	Mendoza	Mendozav
20	Sanatorio Britanico S.A.	Cerana, Susana Helvecia	Argentina	Santa Fe	Rosario
21	Hospital Italiano	Fantl, Dorotea	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
22	Hospital Italiano de La Plata	Enrico, Alicia	Argentina	Buenos Aires	La Plata
23	Instituto Medico Especializado Alexander Fleming	Foncuberta, Cecilia	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
24	Border Medical Oncology	Eek, Richard	Australia	New South Wales	Wodonga
25	Royal Prince Alfred Hospital	Joy, Ho	Australia	New South Wales	Camperdown
26	Box Hill Hospital	Schwarer, Anthony	Australia	Victoria	Box Hill
27	Royal North Shore Hospital	Kerridge, Ian	Australia	New South Wales	St Leonards
28	Royal Perth Hospital	Cannell, Paul	Australia	Western Australia	Perth
29	The Alfred Hospital	Spencer, Andrew	Australia	Victoria	Melbourne
30	Gosford Hospital	Forsyth, Cecily	Australia	New South Wales	Gosford
31	Royal Adelaide Hospital	Horvath, Noemi	Australia	South Australia	Adelaide
32	Calvary Mater Newcastle	Rowlings, Philip	Australia	New South Wales	Waratah
33	St Vincent's Hospital Sydney	Fay, Keith	Australia	New South Wales	Darlinghurst
34	St Vincent's Hospital Melbourne	Quach, Hang	Australia	Victoria	Fitzroy
35	Hospital de Clínicas de Porto Alegre	Bittencourt, Rosane Isabel	Brazil	Rio Grande do Sul	Porto Alegre
36	Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP	Oliveira Duarte, Gislaine	Brazil	Sao Paulo	Campinas
37	Liga Norte Riograndense Contra o Cancer	Farley Rafael Maciel, James	Brazil	Rio Grande do Norte	Natal
38	Irmandade da Santa Casa de Misericordia de Porto Alegre	Fogliatto, Laura Maria	Brazil	Rio Grande do Sul	Porto Alegre
39	Irmandade da Santa Casa de Misericordia de Sao Paulo	Tietsche de Moraes Hungria, Vania	Brazil	Sao Paulo	Sao Paulo
40	Hospital Universitario Clementino Fraga Filho - UFRJ	Maiolino, Angelo	Brazil	Rio do Janeiro	Rio de Janeiro
41	Hospital das Clinicas da Faculdade de Medicina da USP	Martinez, Gracia Aparecida	Brazil	Sao Paulo	Sao Paulo
42	COI - Clinicas Oncologicas Integradas	Martinez, Gracia Aparecida	Brazil	Rio do Janeiro	Rio do Janeiro
43	Hospital Sao Lucas da PUCRS	D'Agord Schaan, Mariza	Brazil	Rio Grande do Sul	Porto Alegre
44	INCA - Instituto Nacional de Cancer	Alves de Souza Scheliga, Adriana	Brazil	Rio do Janeiro	Rio do Janeiro
45	CliniOnco - Tratamento Integrado do Cancer	Albuquerque Zadra, Cyntia	Brazil	Rio Grande do Sul	Porto Alegre
46	Hospital de Caridade de Ijui	Franke, Fabio Andre	Brazil	Rio Grande do Sul	Ijui
47	Fundacao Doutor Amaral Carvalho	de Mattos, Ederson Roberto	Brazil	Sao Paulo	Jau
48	Hospital de Cancer de Barretos - Fundacao Pio XII	Navarro Barros	Brazil	Sao Paulo	Barretos
49	The General Hospital	Grewal, Kuljit	Canada	Newfoundland	St. John's
50	William Osler Health Centre	Kuruvilla, Philip	Canada	Ontario	Brampton
51	Centre de sante et de services sociaux Champlain-Charles-Le Moyne	Fox, Susan	Canada	Quebec	Greenfield Park
52	The Catholic University of Korea Seoul St. Mary’s Hospital	Min, Chang-Ki	Korea	Seoul	Seoul
53	Pusan National University Hospital	Chung, Joo Seop	Korea	Busan	Busan
54	Gachon University Gil Medical Center	Lee, Jae Hoon	Korea	Incheon	Incheon
55	Kyungpook National University Hospital	Moon, Joon Ho	Korea	Daegu	Daegu
56	Samsung Medical Center	Kim, Kihyun	Korea	Seoul	Seoul
57	Severance Hospital, Yonsei University Health System	Kim, Jin Seok	Korea	Seoul	Seoul
58	Seoul National University Hospital	Yoon, Sung-Soo	Korea	Seoul	Seoul
59	Inje University Busan Paik Hospital	Lee, Won-Sik	Korea	Busan	Busan
60	Chonnam National University Hwasun Hospital	Lee, Je Jung	Korea	Jeollanam-do	Hwasun-gun
61	Seoul National University Bundang Hospital	Lee, Jeong-Ok	Korea	Gyeonggi-do	Seongnam-si
62	Asan Medical Center	Yoon, Dok Hyun	Korea	Seoul	Seoul
63	National Cancer Center	Eom, HyeonSeok	Korea	Gyeonggi-do	Goyang-si
64	Centro de Hematologia y Medicina Interna	Ruiz Argüelles, Guillermo	Mexico	Puebla	Puebla
65	Accelerium S. de R.L. de C.V.	Villela Martinez, Luis Mario	Mexico	Nuevo Leon	Monterrey
66	Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran	Martinez Banos, Deborah	Mexico	Distrito Federal	Mexico
67	Hospital Universitario Dr Jose Eleuterio Gonzalez	Gomez Almaguer, David	Mexico	Nuevo Leon	Monterrey
68	North Shore Hospital	Simpson, David	New Zealand	Auckland	Auckland
69	Canterbury Health Laboratories	Ganly, Peter	New Zealand	Christchurch	Christchurch
70	Auckland Clinical Studie	Doocey, Richard	New Zealand	Auckland	Auckland
71	Wellington Hospital	Buyck, Huib	New Zealand	Wellington	Wellington
72	National University Hospital	Chng, Wee Joo	Singapore	Singapore	Singapore
73	Singapore Oncology Consultants	Hsieh, Wen Son	Singapore	Singapore	Singapore
74	Singapore General Hospital- Parent	Goh, Yeow Tee	Singapore	Singapore	Singapore
75	Raffles Hospital	Tan, Daryl	Singapore	Singapore	Singapore
76	OncoCare Cancer Centre	Tay, Kevin	Singapore	Singapore	Singapore
77	China Medical University Hospital	Yeh, Su-Peng	China	Taiwan	Taichung
78	National Taiwan University Hospital	Huang, Shang-Yi	China	Taiwan	Taipei
79	Chang-Gung Memorial Hospital, Linkou	Lin, Tung-Liang	China	Taiwan	Taoyuan County
80	Taipei Veterans General Hospita	Liu, Jin-Hwang	China	Taiwan	Taipei
81	Kaohsiung Chang Gung Memorial Hospital	Wang, Ming-Chung	China	Taiwan	Kaohsiung
82	Changhua Christian Hospital	Chang, Cheng-Shyong	China	Taiwan	Changhua
83	New York - Presbyterian/Weill Cornell Medical Center	Niesvizky, Ruben	USA	New York	New York
84	Gabrail Cancer Center	Gabrail, Nashat	USA	Ohio	Canton
85	The Center for Cancer Care	Hagenstad, Christopher	USA	Georgia	Lawrenceville
86	Huntington Medical Group	Akhund, Birjis	USA	New York	Huntington Sta
87	Innovative Clinical Research Institute	Agajanian, Richy	USA	California	Whittier
88	Marin Cancer Care	Eisenberg, Peter	USA	California	Greenbrae
89	Missouri Baptist Cancer Ctr	Lyss, Alan	USA	Missouri	St Louis
90	Sutter Gould Medical Foundation	Shiba, David	USA	California	Modesto
91	Oncology Consultants, P.A.	Peguero, Julio	USA	Texas	Houston
92	Harrington Cancer Ctr	Sharp, Stewart	USA	Texas	Amarillo
93	Spartanburg Regional Healthcare System	Pati, Asim	USA	South Carolina	Spartanburg
94	Medical Oncology Associates of Augusta PC	Townsend, Donald	USA	Georgia	Augusta
95	Sharp Memorial Hospital	Belani, Rajesh	USA	California	San Diego
96	University of Washington - Seattle Cancer Care Alliance	Libby, Edward	USA	Washington	Seattle
97	University of Florida	Moreb, Jan	USA	Florida	Gainesville
98	California Cancer Associates for Research & Excellence, Inc.	Hager, Steven	USA	California	Fresno
99	Billings Clinic Cancer Center	Whittenberger, Brock	USA	Montana	Billings
100	Maimonides Medical Clinic	Solomon, William	USA	New York	Brooklyn
101	Saint Francis Health System	Spitzer, Gary	USA	South Carolina	Greenville
102	Lynne Kaminer	Kaminer, Lynne	USA	Illinois	Evanston
103	Santee Hematology Oncology	Clowney, Billy	USA	South Carolina	Sumter
104	Vienna Wilhelminen Hospital	Niklas, Zojer	Austria	Vienna	Vienna
105	Elisabeth Linz Hospital	Hedwig Kasparu	Austria	Upper Austria	Linz
106	Salzburg Regional Hospital, Clinic of Internal Medicine III	Richard Greil	Austria	Salzburg	Salzburg
107	University Clinic for Internal Medicine V	Eberhard Gunsilius	Austria	Tyrol	Innsbruck
108	ZNA, Stuivenberg	Ka Lung Wu	Belgium	Antwerpen	Antwerp
109	Saint Joseph Clinic Arlon, Department of Hematology	Nicolas Weynants	Belgium	Luxembourg	Arlon
110	CHU Mont-Godinne	Chantal Doyen	Belgium	Namur	Yvoir
111	Citadelle Regional Hospital Center	Steven Van Steenweghen	Belgium	Liege	Liege
112	University Multiprofile Hospital for Active Treatment“Sveti Georgi”, Plovdiv, Hematology Clinic	Vesselina Goranova-Marinova	Bulgaria	Plovdiv	Plovdiv
113	Multiprofile Hospital for Active Treatment “Sveta Marina”, Varna	Liana Gercheva-Kyuchukova	Bulgaria	Varna	Varna
114	Military Medical Academy – Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic	Julian Raynov	Bulgaria	Sofia	Sofia
115	University Multiprofile Hospital for Active Treatment “Sveti Georgi”, Plovdiv, Oncology and Hematology Clinic	Janet Grudeva-Popova	Bulgaria	Plovdiv	Plovdiv
116	Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic	Georgi Mihaylov	Bulgaria	Sofia	Sofia
117	University Hospital Hradec Kralove, 4th Department of Internal Medicine - Clinical Hematology	Vladimir Maisnar	Czech Rep	Hradec Kralove	Hradec Kralove
118	General University Hospital Prague, 1st Department of Medicine - Department of Hematology	Ivan Spicka	Czech Rep	Central Bohemian	Prague
119	University Hospital Brno, Department of Internal Hematology and Oncology	Ludek Pour	Czech Rep	South Moravian	Brno
120	University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology	Vlastimil Scudla	Czech Rep	Moravia	Olomouc
121	University Hospital Kralovske Vinohrady – Internal Hematology Clinic	Evzen Gregora	Czech Rep	Central Bohemian	Prague
122	University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO	Roman Hajek	Czech Rep	Moravian-Silesian	Ostrava
123	Hospital Necker	Richard Delarue	France	Ile-de-France	Paris
124	CHRU Lille Hopital Claude Huriez	Thierry Facon	France	Nord-Pas-de-Calais	Lille
125	Nantes University Hospital Center	Philippe Moreau	France	Pays de la Loire	Nantes Cedex 1
126	Hospital Purpan	Michel Attal	France	Midi-Pyrenees	Toulouse Cedex 9
127	Institut Paoli Calmettes, Onco Hematologie 1	Anne-Marie Stoppa	France	Provence	Marseille
128	Centre hospitalier Lyon Sud, Service d'hematologie Clinique	Lionel Karlin	France	Pays de la Loire	Pierre Benite, cedex
129	Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau	Eric Jourdan	France	Languedoc-Roussillon	Nimes cedex 09
130	Hopital Saint Louis, Service d'Immuno-Hematologie du Pr. FERMAND	Bertrand Arnulf	France	Ile-de-France	Paris
131	Chu De Rennes Hopital Pontchaillou	Martine Escoffre-Barbe	France	Bretagne	Rennes Cedex 9
132	CHU Estaing	Carine Chaleteix	France	Auvergne	Clermont-Ferrand
133	CHU de Caen, Cote de Nacre	Margaret Macro	France	Basse-Normandie	Caen Cedex 9
134	CHU de Bordeaux, Hopital du Haut Leveque	Gerald Marit	France	Pessac cedex	Pessac
135	CHU de Tours, Hopital Bretonneau	Lotfi Benboubker	France	Region Centre	Tours Cedex 1
136	Hopital Saint Antoine	Laurent Garderet	France	Ile-de-France	Paris
137	CHU Dijon - Hopital d'Enfants	Denis Caillot	France	Region Bourgogne	Dijon
138	Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine	Ralph Naumann	Germany	Rheinland-Pfalz	Koblenz
139	Heidelberg Medical University, Medical Clinic V, Department of Haematology, Oncology and Rheumatology	Hartmut Goldschmidt	Germany	Baden-Wuerttemberg	Heidelberg
140	Ludwig Maximilians University Hospital	Helmut Ostermann	Germany	Bavaria	Munich
141	University Hospital Duesseldorf, Dept. Of Hematology, Oncology And Clinical Immunology	Roland Fenk	Germany	North Rhine-Westphalia	Duesseldorf
142	Saarland University Clinic, Department of Internal Medicine I	Michael Pfreundschuh	Germany	Saarland	Homburg
143	Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III	Markus Munder	Germany	Rhineland-Palatinate	Mainz
144	Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III	Miriam Kull	Germany	Baden-Wuerttemberg	Ulm
145	Freiburg University Clinic	Monika Engelhardt	Germany	Baden-Wuertemberg	Freiburg
146	Group Practice for Hematology and Oncology	Christoph Roellig	Germany	Saxony	Dresden
147	University Hospital Cologne	Christof Scheid	Germany	Nordrhein-Westfalen	Cologne
148	Evangelismos Hospital	Sossana Delimpasi	Greece	Attica	Athens
149	Department of Clinical Therapeutics, University of Athens, Alexandra Hospital	Meletios-Athanassios Dimopoulos	Greece	Attica	Athens
150	Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology	Janos Jakucs	Hungary	Bekes County	Gyula
151	Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology	Miklos Egyed	Hungary	Somogy County	Kaposvar
152	St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant	Tamas Masszi	Hungary	Budapest	Budapest
153	Medical Center of the University of Pecs, 1st Clinic for Internal Medicine	Arpad Szomor	Hungary	Baranya County	Pecs
154	University of Szeged, Albert Szent-Gyorgyi Clinical Center, 2nd Department of Internal Medicine and Cardiology, Hematology Unit	Zita Borbenyi	Hungary	Csongrad County	Szeged
155	University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology	arpad Illes	Hungary	Hajdu-Bihar	Debrecen
156	Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine	Mihaly Gurzo	Hungary	Bacs-Kiskun county	Kecskemet
157	National Institute of Oncology, Department of Oncology, Internal Medicine “A” and Hematology	Andras Rosta	Hungary	Budapest	Budapest
158	Ein Kerem Hospital, Department of Hematology	Dina Ben-Yehuda	Israel	Jerusalem	Jerusalem
159	Rambam Medical Center, Department of Hematology	Netanel Horowitz	Israel	Haifa	Haifa
160	Chaim Sheba Medical Center, Bone Marrow Transplantation Unit	Arnon Nagler	Israel	Tel Aviv	Tel Hashomer
161	Meir Medical Center, Department of Hematology	Izhar Hardan	Israel	Tel Aviv	Kfar-Saba
162	Soroka University Medical Center	Ory Rouvio	Israel	Tel Aviv	Beer-Sheva
163	AO Citta della Salute e della Scienza di Torino, Division of Hematology	Antonio Palumbo	Italy	Piemonte	TORINO
164	Ospedale S. Eugenio	Paolo De Fabritiis	Italy	Lazio	Rome
165	A.O.U. “Maggiore della Carita - Novara”	Davide Rossi	Italy	Piemonte	Novara
166	Azienda Ospedaliera Universitaria Federico II di Napoli	Fabrizio Pane	Italy	Campania	Napoli
167	AOU Ospedali Riuniti Ancona, Clinic of Hematology	Massimo Offidani	Italy	Marche	TORRETTE di Ancona
168	Policlinico Universitario “Umberto I”, Dipartimento di Biotecnologie Cellulari e Ematologia	Roberto Foa	Italy	Lazio	Rome
169	IRCCS University Hospital S. MARTINO - IST National Institute for cancer reseach Department of Internal Medicine and medical specialties Hematologic Clinic	Marco Gobbi	Italy	Liguria	Genova
170	San Luigi University Hospital, Division of Internal Medicine and Hematology	Tommasina Guglielmelli	Italy	Piemonte	Orbassano (TO)
171	Local NHS of Piacenza Hospital “Guglielmo da Saliceto”, Department Oncology-Hematology, Unit of Hematology	Antonio Lazzaro	Italy	Emilia-Romagna	Piacenza
172	Erasmus Medical Center	Pieter Sonneveld	Netherlands	South Holland	Rotterdam
173	Isala Klinieken	Marinus van Marwijk Kooy	Netherlands	Gelderland	Zwolle
174	Vrije Universiteit Medisch Centrum	Sonja Zweegman	Netherlands	North Holland	Amsterdam
175	St. Antonius Hospital	Maaike Sohne	Netherlands	Utrecht	Nieuwegein
176	Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz	Tadeusz Robak	Poland	Lodz	Lodz
177	Maria Sklodowska-Curie Institute of Oncology	Jan Walewski	Poland	Mazowieckie	Warsaw
178	Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice	Slawomira Kyrcz-Krzemien	Poland	Silesian Voivodeship	Katowice
179	Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology	Sebastian Grosicki	Poland	Slaskie	Chorzow
180	Independent Public Teaching Hospital No.1 in Lublin	Marek Hus	Poland	Lubelskie	Lublin
181	Independent Public Healthcare Facility University Hospital in Cracow, Teaching Unit of the Hematology Department	Artur Jurczyszyn	Poland	Malopolskie Voivodship	Krakow
182	Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology	Malgorzata Calbecka	Poland	Kujawsko-pomorskie	Torun
183	Independent Public Healthcare Facility of the Ministry of Internal Affairs and Administration and Warminsko – Mazurskie Oncology Centre in Olsztyn	Wanda Knopinska-Posluszny	Poland	Warminsko-Mazurskie	Olsztyn
184	Coltea Clinical Hospital, Hematology Department	Nicoleta Berbec	Romania	Bucharest	Bucharest
185	Bucharest Emergency University Hospital, Hematology Department	Horia Bumbea	Romania	Bucharest	Bucharest
186	Fundeni Clinical Institute, Hematology Department	Daniel Coriu	Romania	Bucharest	Bucharest
187	Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation	Istvan Benedek	Romania	Mures county	Targu-Mures
188	Brasov County Emergency Clinical Hospital, Hematology Department	Emanuil Gheorghita	Romania	Brasov County	Brasov
189	“Prof. Dr. Ion Chiricuta” Institut of Oncology, Hematology Department	Andrei Cucuianu	Romania	Cluj County	Cluj-Napoca
190	Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care	Kudrat Abdulkadyrov	Russia	St. Petersburg	St. Petersburg
191	State Higher Educational Institution: St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development, Bone Marrow Transplantation Clinic	Boris Afanasyev	Russia	St. Petersburg	St. Petersburg
192	Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences	Dzhelil Osmanov	Russia	Moscow	Moscow
193	City Clinical Hospital N.A. S. P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders	Nuriet Khuazheva	Russia	Moscow	Moscow
194	State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia	Alexander Suvorov	Russia	Udmurtia	Izhevsk
195	City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders	Elleonora Podoltseva	Russia	St. Petersburg	St. Petersburg
196	Nikiforov Russian Center for Emergency and Radiology Medicine	Sergey Moiseev	Russia	St. Petersburg	St. Petersburg
197	Medical Radiology Research Center	Vyacheslav Pavlov	Russia	Kaluga	Obninsk
198	Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2	Yuri Dunaev	Russia	Arkhangelsk	Arkhangelsk
199	State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology	Alexander Myasnikov	Russia	Republic of Karelia	Petrozavodsk
200	Hospital de día-Quirón-La Floresta	Pilar Giraldo	Spain	Aragon	Zaragoza, Aragón
201	Hospital Universitari Germans Trias i Pujol	Albert Oriol	Spain	Barselona	Badalona
202	Clinica Universidad de Navarra	Jesus San Miguel	Spain	Navarra	Pamplona
203	Hospital Universitario, Salamanca	Maria Victoria Mateos	Spain	Castile-La Mancha	Salamanca
204	Universitari i Politecnic la Fe de Valencia Consulta Externa de Hematologia	Javier De la Rubia	Spain	Valencia	Valencia
205	Hospital Clinic Barcelona	Laura Rosinol	Spain	Catalonian	Barcelona
206	Hospital Virgen del Rocio University	Jesus Martin Sanchez	Spain	Andalusia	Sevilla
207	Hospital Universitario 12 De Octubre	Joaquin Martinez de Lopez	Spain	Madrid	Madrid
208	Kantonsspital Sankt Gallen	Christoph Driessen	Switzerland	St. Gallen	St. Gallen
209	Centre Hospitalier Universitaire Vaudois	Anne Cairoli	Switzerland	Vaud	Lausanne
210	Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department	Meral Beksac	Turkey	Ankara	Ankara
211	Marmara University Research and Training Hospital, Haematology Department	Tulin Tuglular	Turkey	Istanbul	Istanbul
212	Ege University Medical Faculty Hematology Department	Filiz Vural	Turkey	Izmir	Izmir
213	The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital	Supratik Basu	UK	England	Wolverhampton
214	University College London, Cancer Centre	Kwee Yong	UK	England	London
215	Churchill Hospital, Cancer and Haematology Centre	Karthik Ramasamy	UK	England	Oxford
216	Raigmore Hospital	Peter Forsyth	UK	Scotland	Inverness
217	Northwick Park Hospital	Charalampia Kyriakou	UK	England	Harrow
218	Guy's and St. Thomas' NHS Foundation Trust？	Matthew Streetly	UK	England	London
219	Kent and Canterbury Hospital	Jindriska Lindsay	UK	England	Canterbury
220	Maidstone Hospital, Kent Oncology Centre	Saad Rassam	UK	England	Maidstone
221	Kharkiv Regional Clinical Oncology Center, Department of Hematology	Yuri Vinnyk	Ukraine	Kharkiv Oblast	Kharkiv
222	Cherkasy Regional Oncology Center	Halyna Pylypenko	Ukraine	Lviv Oblast	Cherkasy
223	Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre	Polina Kaplan	Ukraine	Dnipropetrovsk	Dnipropetrovsk
224	Kyiv Center for Bone Marrow Transplantation	Yevhen Karamanesht	Ukraine	Kyiv	Kyiv
225	O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center	Tamila Lysa	Ukraine	Zhytomyr Oblast	Zhytomyr
226	Institute of Blood Pathology and Transfusion Medicine	Zvenyslava Masliak	Ukraine	Lviv Oblast	Lviv
227	Khmelnytskyi Regional Hospital, Hematology Department	Grygoriy Rekhtman	Ukraine	Khmelnytskyi Oblast	Khmelnytskyi
228	M.I.Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department	Hanna Oliynyk	Ukraine	Vinnytsia Oblast	Vinnitsya
229	V.K. Husak Institute of Urgent and Reconstructive Surgery under the Ukrainian Academy of Medical Sciences, Hematology Department	Kateryna Vilchevska	Ukraine	Donetsk Oblast	Donetsk
230	Poltava M.V. Sklifosovskyi Regional Clinical Hospital, Department of Hematology	Igor Skrypnyk	Ukraine	Kharkiv Oblast	Poltava
231	Andrii Novak Zakarpattia Regional Clinical Hospital, Department of Hematology	Yurii Popovych	Ukraine	Zakarpattia Oblast	Uzhhorod
232	浙江大学医学院附属第一医院	蔡真	中国	浙江省	杭州市
233	上海长征医院	侯健	中国	上海市	上海市

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	同意	2014-04-30
2	中国医学科学院血液病医院伦理委员会	同意	2014-06-17
3	中国医学科学院血液病医院伦理委员会	同意	2014-06-17

进行中（招募完成）

目标入组人数	国内: 计划入组约100 ； 国际: 入组882 ；
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: 102  ； 国际: 955 ；

第一例受试者签署知情同意书日期	国内：2014-08-12；     国际：2013-07-08；
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：登记人暂未填写该信息；     国际：登记人暂未填写该信息；