登记号
CTR20140135
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
初诊的不符合移植条件的多发性骨髓瘤
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
试验方案编号
2012-005
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
段若竹
联系人座机
010-65997954
联系人手机号
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
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
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。
随机化
随机化
盲法
开放
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
N/A岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 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）
- 不符合移植条件
- 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 < 0.26或> 1.65）
- 既往未接受过多发性骨髓瘤治疗
- 年龄≥ 18岁的男性和女性
- 美国东部肿瘤协作组（ECOG）体能状态评分0–2分
- 随机化前21天内有足够的肝功能，其中胆红素<1.5倍正常值上限（ULN），谷草转氨酶（AST）和谷丙转氨酶（ALT）< 3 倍ULN
- 中性粒细胞绝对值（ANC）≥ 1.0 × 109/L
- 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
- 血小板计数 ≥ 50 × 109/L
- 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。
- 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）
- 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）。
- 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
- 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
- IgM（免疫球蛋白M）亚型的多发性骨髓瘤
- 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
- 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）
- 浆细胞白血病（外周血浆细胞> 2.0 × 109/L）
- Waldenstrom巨球蛋白血症（WM）
- 已知的淀粉样变性
- 随机化前7天内接受过局部放射治疗
- 随机化前21天内接受过任何免疫疗法
- 随机化前21天内接受过大手术
- 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
- 随机化前14天内有活动性感染
- 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）
- 已知有肝硬化
- 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
- 骨髓增生异常综合征
- 随机化前14天内显著精神病变（等级≥2）
- 受试者为妊娠或哺乳期女性
- 已知的Captisol过敏史（用于溶解卡非佐米的环糊精衍生物）
- 对硼或甘露醇（与硼替佐米给药相关）具有超敏反应
- 对美法仑或所有爱克兰辅料具有超敏反应
- 强的松/地塞米松禁忌症
- 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
- 需进行胸腔穿刺术的胸腔积液
- 需进行穿刺术的腹水
- 未控制的高血压或未控制的糖尿病
- 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
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
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36 mg/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36 mg/m2。
|
|
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9 mg/m2。
|
|
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60 mg/m2。
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:注射用硼替佐米英文名： Bortezomib for Injection 商品名：万珂
|
用法用量:注射剂；规格3.5mg/瓶；1.3 mg/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。
|
|
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9 mg/m2。
|
|
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60 mg/m2。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 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
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 邱录贵，医学博士 | 教授 | 022-23909172 | drqiu99@medmail.com.cn | 天津市和平区南京路288号 | 300041 | 中国医学科学院血液学研究所血液病医院 |
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学研究所血液病医院 | 邱录贵 | 中国 | 天津市 | 天津市 |
| 吉林大学第一医院 | 李薇 | 中国 | 吉林省 | 长春市 |
| 北京协和医院 | 周道斌 | 中国 | 北京市 | 北京市 |
| 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 |
| 北京朝阳医院 | 陈文明 | 中国 | 北京市 | 北京市 |
| 苏州大学附属第一医院 | 傅铮铮 | 中国 | 江苏省 | 苏州市 |
| 北京大学第三医院 | 克晓燕 | 中国 | 北京市 | 北京市 |
| 福建医科大学附属协和医院 | 刘庭波 | 中国 | 福建省 | 福州市 |
| 西京医院 | 陈协群 | 中国 | 陕西省 | 西安市 |
| 上海长海医院 | 王健民 | 中国 | 上海市 | 上海市 |
| 中国人民解放军三〇七医院 | 陈虎 | 中国 | 北京市 | 北京市 |
| 四川大学华西医院 | 刘霆 | 中国 | 四川省 | 成都市 |
| 中山大学附属肿瘤医院 | 吕跃 | 中国 | 广东省 | 广州市 |
| 天津医科大学肿瘤医院 | 张翼鷟 | 中国 | 天津市 | 天津市 |
| 广州市第一人民医院 | 王顺青 | 中国 | 广东省 | 广州市 |
| 浙江大学医学院附属第一医院 | 金洁 | 中国 | 浙江省 | 杭州市 |
| 广东省人民医院 | 杜欣 | 中国 | 广东省 | 广州市 |
| CEMIC | Riveros, Dardo | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| COIR Fundacion Centro Oncologico de Integracion Regional | Viudez, Maria Laura | Argentina | Mendoza | Mendozav |
| Sanatorio Britanico S.A. | Cerana, Susana Helvecia | Argentina | Santa Fe | Rosario |
| Hospital Italiano | Fantl, Dorotea | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Hospital Italiano de La Plata | Enrico, Alicia | Argentina | Buenos Aires | La Plata |
| Instituto Medico Especializado Alexander Fleming | Foncuberta, Cecilia | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Border Medical Oncology | Eek, Richard | Australia | New South Wales | Wodonga |
| Royal Prince Alfred Hospital | Joy, Ho | Australia | New South Wales | Camperdown |
| Box Hill Hospital | Schwarer, Anthony | Australia | Victoria | Box Hill |
| Royal North Shore Hospital | Kerridge, Ian | Australia | New South Wales | St Leonards |
| Royal Perth Hospital | Cannell, Paul | Australia | Western Australia | Perth |
| The Alfred Hospital | Spencer, Andrew | Australia | Victoria | Melbourne |
| Gosford Hospital | Forsyth, Cecily | Australia | New South Wales | Gosford |
| Royal Adelaide Hospital | Horvath, Noemi | Australia | South Australia | Adelaide |
| Calvary Mater Newcastle | Rowlings, Philip | Australia | New South Wales | Waratah |
| St Vincent's Hospital Sydney | Fay, Keith | Australia | New South Wales | Darlinghurst |
| St Vincent's Hospital Melbourne | Quach, Hang | Australia | Victoria | Fitzroy |
| Hospital de Clínicas de Porto Alegre | Bittencourt, Rosane Isabel | Brazil | Rio Grande do Sul | Porto Alegre |
| Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP | Oliveira Duarte, Gislaine | Brazil | Sao Paulo | Campinas |
| Liga Norte Riograndense Contra o Cancer | Farley Rafael Maciel, James | Brazil | Rio Grande do Norte | Natal |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Fogliatto, Laura Maria | Brazil | Rio Grande do Sul | Porto Alegre |
| Irmandade da Santa Casa de Misericordia de Sao Paulo | Tietsche de Moraes Hungria, Vania | Brazil | Sao Paulo | Sao Paulo |
| Hospital Universitario Clementino Fraga Filho - UFRJ | Maiolino, Angelo | Brazil | Rio do Janeiro | Rio de Janeiro |
| Hospital das Clinicas da Faculdade de Medicina da USP | Martinez, Gracia Aparecida | Brazil | Sao Paulo | Sao Paulo |
| COI - Clinicas Oncologicas Integradas | Martinez, Gracia Aparecida | Brazil | Rio do Janeiro | Rio do Janeiro |
| Hospital Sao Lucas da PUCRS | D'Agord Schaan, Mariza | Brazil | Rio Grande do Sul | Porto Alegre |
| INCA - Instituto Nacional de Cancer | Alves de Souza Scheliga, Adriana | Brazil | Rio do Janeiro | Rio do Janeiro |
| CliniOnco - Tratamento Integrado do Cancer | Albuquerque Zadra, Cyntia | Brazil | Rio Grande do Sul | Porto Alegre |
| Hospital de Caridade de Ijui | Franke, Fabio Andre | Brazil | Rio Grande do Sul | Ijui |
| Fundacao Doutor Amaral Carvalho | de Mattos, Ederson Roberto | Brazil | Sao Paulo | Jau |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Navarro Barros | Brazil | Sao Paulo | Barretos |
| The General Hospital | Grewal, Kuljit | Canada | Newfoundland | St. John's |
| William Osler Health Centre | Kuruvilla, Philip | Canada | Ontario | Brampton |
| Centre de sante et de services sociaux Champlain-Charles-Le Moyne | Fox, Susan | Canada | Quebec | Greenfield Park |
| The Catholic University of Korea Seoul St. Mary’s Hospital | Min, Chang-Ki | Korea | Seoul | Seoul |
| Pusan National University Hospital | Chung, Joo Seop | Korea | Busan | Busan |
| Gachon University Gil Medical Center | Lee, Jae Hoon | Korea | Incheon | Incheon |
| Kyungpook National University Hospital | Moon, Joon Ho | Korea | Daegu | Daegu |
| Samsung Medical Center | Kim, Kihyun | Korea | Seoul | Seoul |
| Severance Hospital, Yonsei University Health System | Kim, Jin Seok | Korea | Seoul | Seoul |
| Seoul National University Hospital | Yoon, Sung-Soo | Korea | Seoul | Seoul |
| Inje University Busan Paik Hospital | Lee, Won-Sik | Korea | Busan | Busan |
| Chonnam National University Hwasun Hospital | Lee, Je Jung | Korea | Jeollanam-do | Hwasun-gun |
| Seoul National University Bundang Hospital | Lee, Jeong-Ok | Korea | Gyeonggi-do | Seongnam-si |
| Asan Medical Center | Yoon, Dok Hyun | Korea | Seoul | Seoul |
| National Cancer Center | Eom, HyeonSeok | Korea | Gyeonggi-do | Goyang-si |
| Centro de Hematologia y Medicina Interna | Ruiz Argüelles, Guillermo | Mexico | Puebla | Puebla |
| Accelerium S. de R.L. de C.V. | Villela Martinez, Luis Mario | Mexico | Nuevo Leon | Monterrey |
| Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran | Martinez Banos, Deborah | Mexico | Distrito Federal | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Gomez Almaguer, David | Mexico | Nuevo Leon | Monterrey |
| North Shore Hospital | Simpson, David | New Zealand | Auckland | Auckland |
| Canterbury Health Laboratories | Ganly, Peter | New Zealand | Christchurch | Christchurch |
| Auckland Clinical Studie | Doocey, Richard | New Zealand | Auckland | Auckland |
| Wellington Hospital | Buyck, Huib | New Zealand | Wellington | Wellington |
| National University Hospital | Chng, Wee Joo | Singapore | Singapore | Singapore |
| Singapore Oncology Consultants | Hsieh, Wen Son | Singapore | Singapore | Singapore |
| Singapore General Hospital- Parent | Goh, Yeow Tee | Singapore | Singapore | Singapore |
| Raffles Hospital | Tan, Daryl | Singapore | Singapore | Singapore |
| OncoCare Cancer Centre | Tay, Kevin | Singapore | Singapore | Singapore |
| China Medical University Hospital | Yeh, Su-Peng | China | Taiwan | Taichung |
| National Taiwan University Hospital | Huang, Shang-Yi | China | Taiwan | Taipei |
| Chang-Gung Memorial Hospital, Linkou | Lin, Tung-Liang | China | Taiwan | Taoyuan County |
| Taipei Veterans General Hospita | Liu, Jin-Hwang | China | Taiwan | Taipei |
| Kaohsiung Chang Gung Memorial Hospital | Wang, Ming-Chung | China | Taiwan | Kaohsiung |
| Changhua Christian Hospital | Chang, Cheng-Shyong | China | Taiwan | Changhua |
| New York - Presbyterian/Weill Cornell Medical Center | Niesvizky, Ruben | USA | New York | New York |
| Gabrail Cancer Center | Gabrail, Nashat | USA | Ohio | Canton |
| The Center for Cancer Care | Hagenstad, Christopher | USA | Georgia | Lawrenceville |
| Huntington Medical Group | Akhund, Birjis | USA | New York | Huntington Sta |
| Innovative Clinical Research Institute | Agajanian, Richy | USA | California | Whittier |
| Marin Cancer Care | Eisenberg, Peter | USA | California | Greenbrae |
| Missouri Baptist Cancer Ctr | Lyss, Alan | USA | Missouri | St Louis |
| Sutter Gould Medical Foundation | Shiba, David | USA | California | Modesto |
| Oncology Consultants, P.A. | Peguero, Julio | USA | Texas | Houston |
| Harrington Cancer Ctr | Sharp, Stewart | USA | Texas | Amarillo |
| Spartanburg Regional Healthcare System | Pati, Asim | USA | South Carolina | Spartanburg |
| Medical Oncology Associates of Augusta PC | Townsend, Donald | USA | Georgia | Augusta |
| Sharp Memorial Hospital | Belani, Rajesh | USA | California | San Diego |
| University of Washington - Seattle Cancer Care Alliance | Libby, Edward | USA | Washington | Seattle |
| University of Florida | Moreb, Jan | USA | Florida | Gainesville |
| California Cancer Associates for Research & Excellence, Inc. | Hager, Steven | USA | California | Fresno |
| Billings Clinic Cancer Center | Whittenberger, Brock | USA | Montana | Billings |
| Maimonides Medical Clinic | Solomon, William | USA | New York | Brooklyn |
| Saint Francis Health System | Spitzer, Gary | USA | South Carolina | Greenville |
| Lynne Kaminer | Kaminer, Lynne | USA | Illinois | Evanston |
| Santee Hematology Oncology | Clowney, Billy | USA | South Carolina | Sumter |
| Vienna Wilhelminen Hospital | Niklas, Zojer | Austria | Vienna | Vienna |
| Elisabeth Linz Hospital | Hedwig Kasparu | Austria | Upper Austria | Linz |
| Salzburg Regional Hospital, Clinic of Internal Medicine III | Richard Greil | Austria | Salzburg | Salzburg |
| University Clinic for Internal Medicine V | Eberhard Gunsilius | Austria | Tyrol | Innsbruck |
| ZNA, Stuivenberg | Ka Lung Wu | Belgium | Antwerpen | Antwerp |
| Saint Joseph Clinic Arlon, Department of Hematology | Nicolas Weynants | Belgium | Luxembourg | Arlon |
| CHU Mont-Godinne | Chantal Doyen | Belgium | Namur | Yvoir |
| Citadelle Regional Hospital Center | Steven Van Steenweghen | Belgium | Liege | Liege |
| University Multiprofile Hospital for Active Treatment“Sveti Georgi”, Plovdiv, Hematology Clinic | Vesselina Goranova-Marinova | Bulgaria | Plovdiv | Plovdiv |
| Multiprofile Hospital for Active Treatment “Sveta Marina”, Varna | Liana Gercheva-Kyuchukova | Bulgaria | Varna | Varna |
| Military Medical Academy – Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic | Julian Raynov | Bulgaria | Sofia | Sofia |
| University Multiprofile Hospital for Active Treatment “Sveti Georgi”, Plovdiv, Oncology and Hematology Clinic | Janet Grudeva-Popova | Bulgaria | Plovdiv | Plovdiv |
| Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic | Georgi Mihaylov | Bulgaria | Sofia | Sofia |
| University Hospital Hradec Kralove, 4th Department of Internal Medicine - Clinical Hematology | Vladimir Maisnar | Czech Rep | Hradec Kralove | Hradec Kralove |
| General University Hospital Prague, 1st Department of Medicine - Department of Hematology | Ivan Spicka | Czech Rep | Central Bohemian | Prague |
| University Hospital Brno, Department of Internal Hematology and Oncology | Ludek Pour | Czech Rep | South Moravian | Brno |
| University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology | Vlastimil Scudla | Czech Rep | Moravia | Olomouc |
| University Hospital Kralovske Vinohrady – Internal Hematology Clinic | Evzen Gregora | Czech Rep | Central Bohemian | Prague |
| University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO | Roman Hajek | Czech Rep | Moravian-Silesian | Ostrava |
| Hospital Necker | Richard Delarue | France | Ile-de-France | Paris |
| CHRU Lille Hopital Claude Huriez | Thierry Facon | France | Nord-Pas-de-Calais | Lille |
| Nantes University Hospital Center | Philippe Moreau | France | Pays de la Loire | Nantes Cedex 1 |
| Hospital Purpan | Michel Attal | France | Midi-Pyrenees | Toulouse Cedex 9 |
| Institut Paoli Calmettes, Onco Hematologie 1 | Anne-Marie Stoppa | France | Provence | Marseille |
| Centre hospitalier Lyon Sud, Service d'hematologie Clinique | Lionel Karlin | France | Pays de la Loire | Pierre Benite, cedex |
| Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau | Eric Jourdan | France | Languedoc-Roussillon | Nimes cedex 09 |
| Hopital Saint Louis, Service d'Immuno-Hematologie du Pr. FERMAND | Bertrand Arnulf | France | Ile-de-France | Paris |
| Chu De Rennes Hopital Pontchaillou | Martine Escoffre-Barbe | France | Bretagne | Rennes Cedex 9 |
| CHU Estaing | Carine Chaleteix | France | Auvergne | Clermont-Ferrand |
| CHU de Caen, Cote de Nacre | Margaret Macro | France | Basse-Normandie | Caen Cedex 9 |
| CHU de Bordeaux, Hopital du Haut Leveque | Gerald Marit | France | Pessac cedex | Pessac |
| CHU de Tours, Hopital Bretonneau | Lotfi Benboubker | France | Region Centre | Tours Cedex 1 |
| Hopital Saint Antoine | Laurent Garderet | France | Ile-de-France | Paris |
| CHU Dijon - Hopital d'Enfants | Denis Caillot | France | Region Bourgogne | Dijon |
| Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine | Ralph Naumann | Germany | Rheinland-Pfalz | Koblenz |
| Heidelberg Medical University, Medical Clinic V, Department of Haematology, Oncology and Rheumatology | Hartmut Goldschmidt | Germany | Baden-Wuerttemberg | Heidelberg |
| Ludwig Maximilians University Hospital | Helmut Ostermann | Germany | Bavaria | Munich |
| University Hospital Duesseldorf, Dept. Of Hematology, Oncology And Clinical Immunology | Roland Fenk | Germany | North Rhine-Westphalia | Duesseldorf |
| Saarland University Clinic, Department of Internal Medicine I | Michael Pfreundschuh | Germany | Saarland | Homburg |
| Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III | Markus Munder | Germany | Rhineland-Palatinate | Mainz |
| Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III | Miriam Kull | Germany | Baden-Wuerttemberg | Ulm |
| Freiburg University Clinic | Monika Engelhardt | Germany | Baden-Wuertemberg | Freiburg |
| Group Practice for Hematology and Oncology | Christoph Roellig | Germany | Saxony | Dresden |
| University Hospital Cologne | Christof Scheid | Germany | Nordrhein-Westfalen | Cologne |
| Evangelismos Hospital | Sossana Delimpasi | Greece | Attica | Athens |
| Department of Clinical Therapeutics, University of Athens, Alexandra Hospital | Meletios-Athanassios Dimopoulos | Greece | Attica | Athens |
| Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology | Janos Jakucs | Hungary | Bekes County | Gyula |
| Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology | Miklos Egyed | Hungary | Somogy County | Kaposvar |
| St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant | Tamas Masszi | Hungary | Budapest | Budapest |
| Medical Center of the University of Pecs, 1st Clinic for Internal Medicine | Arpad Szomor | Hungary | Baranya County | Pecs |
| University of Szeged, Albert Szent-Gyorgyi Clinical Center, 2nd Department of Internal Medicine and Cardiology, Hematology Unit | Zita Borbenyi | Hungary | Csongrad County | Szeged |
| University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology | arpad Illes | Hungary | Hajdu-Bihar | Debrecen |
| Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine | Mihaly Gurzo | Hungary | Bacs-Kiskun county | Kecskemet |
| National Institute of Oncology, Department of Oncology, Internal Medicine “A” and Hematology | Andras Rosta | Hungary | Budapest | Budapest |
| Ein Kerem Hospital, Department of Hematology | Dina Ben-Yehuda | Israel | Jerusalem | Jerusalem |
| Rambam Medical Center, Department of Hematology | Netanel Horowitz | Israel | Haifa | Haifa |
| Chaim Sheba Medical Center, Bone Marrow Transplantation Unit | Arnon Nagler | Israel | Tel Aviv | Tel Hashomer |
| Meir Medical Center, Department of Hematology | Izhar Hardan | Israel | Tel Aviv | Kfar-Saba |
| Soroka University Medical Center | Ory Rouvio | Israel | Tel Aviv | Beer-Sheva |
| AO Citta della Salute e della Scienza di Torino, Division of Hematology | Antonio Palumbo | Italy | Piemonte | TORINO |
| Ospedale S. Eugenio | Paolo De Fabritiis | Italy | Lazio | Rome |
| A.O.U. “Maggiore della Carita - Novara” | Davide Rossi | Italy | Piemonte | Novara |
| Azienda Ospedaliera Universitaria Federico II di Napoli | Fabrizio Pane | Italy | Campania | Napoli |
| AOU Ospedali Riuniti Ancona, Clinic of Hematology | Massimo Offidani | Italy | Marche | TORRETTE di Ancona |
| Policlinico Universitario “Umberto I”, Dipartimento di Biotecnologie Cellulari e Ematologia | Roberto Foa | Italy | Lazio | Rome |
| 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 |
| San Luigi University Hospital, Division of Internal Medicine and Hematology | Tommasina Guglielmelli | Italy | Piemonte | Orbassano (TO) |
| Local NHS of Piacenza Hospital “Guglielmo da Saliceto”, Department Oncology-Hematology, Unit of Hematology | Antonio Lazzaro | Italy | Emilia-Romagna | Piacenza |
| Erasmus Medical Center | Pieter Sonneveld | Netherlands | South Holland | Rotterdam |
| Isala Klinieken | Marinus van Marwijk Kooy | Netherlands | Gelderland | Zwolle |
| Vrije Universiteit Medisch Centrum | Sonja Zweegman | Netherlands | North Holland | Amsterdam |
| St. Antonius Hospital | Maaike Sohne | Netherlands | Utrecht | Nieuwegein |
| Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz | Tadeusz Robak | Poland | Lodz | Lodz |
| Maria Sklodowska-Curie Institute of Oncology | Jan Walewski | Poland | Mazowieckie | Warsaw |
| Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice | Slawomira Kyrcz-Krzemien | Poland | Silesian Voivodeship | Katowice |
| Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology | Sebastian Grosicki | Poland | Slaskie | Chorzow |
| Independent Public Teaching Hospital No.1 in Lublin | Marek Hus | Poland | Lubelskie | Lublin |
| Independent Public Healthcare Facility University Hospital in Cracow, Teaching Unit of the Hematology Department | Artur Jurczyszyn | Poland | Malopolskie Voivodship | Krakow |
| Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology | Malgorzata Calbecka | Poland | Kujawsko-pomorskie | Torun |
| 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 |
| Coltea Clinical Hospital, Hematology Department | Nicoleta Berbec | Romania | Bucharest | Bucharest |
| Bucharest Emergency University Hospital, Hematology Department | Horia Bumbea | Romania | Bucharest | Bucharest |
| Fundeni Clinical Institute, Hematology Department | Daniel Coriu | Romania | Bucharest | Bucharest |
| Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation | Istvan Benedek | Romania | Mures county | Targu-Mures |
| Brasov County Emergency Clinical Hospital, Hematology Department | Emanuil Gheorghita | Romania | Brasov County | Brasov |
| “Prof. Dr. Ion Chiricuta” Institut of Oncology, Hematology Department | Andrei Cucuianu | Romania | Cluj County | Cluj-Napoca |
| 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 |
| 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 |
| 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 |
| 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 |
| State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia | Alexander Suvorov | Russia | Udmurtia | Izhevsk |
| City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders | Elleonora Podoltseva | Russia | St. Petersburg | St. Petersburg |
| Nikiforov Russian Center for Emergency and Radiology Medicine | Sergey Moiseev | Russia | St. Petersburg | St. Petersburg |
| Medical Radiology Research Center | Vyacheslav Pavlov | Russia | Kaluga | Obninsk |
| Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2 | Yuri Dunaev | Russia | Arkhangelsk | Arkhangelsk |
| State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology | Alexander Myasnikov | Russia | Republic of Karelia | Petrozavodsk |
| Hospital de día-Quirón-La Floresta | Pilar Giraldo | Spain | Aragon | Zaragoza, Aragón |
| Hospital Universitari Germans Trias i Pujol | Albert Oriol | Spain | Barselona | Badalona |
| Clinica Universidad de Navarra | Jesus San Miguel | Spain | Navarra | Pamplona |
| Hospital Universitario, Salamanca | Maria Victoria Mateos | Spain | Castile-La Mancha | Salamanca |
| Universitari i Politecnic la Fe de Valencia Consulta Externa de Hematologia | Javier De la Rubia | Spain | Valencia | Valencia |
| Hospital Clinic Barcelona | Laura Rosinol | Spain | Catalonian | Barcelona |
| Hospital Virgen del Rocio University | Jesus Martin Sanchez | Spain | Andalusia | Sevilla |
| Hospital Universitario 12 De Octubre | Joaquin Martinez de Lopez | Spain | Madrid | Madrid |
| Kantonsspital Sankt Gallen | Christoph Driessen | Switzerland | St. Gallen | St. Gallen |
| Centre Hospitalier Universitaire Vaudois | Anne Cairoli | Switzerland | Vaud | Lausanne |
| Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department | Meral Beksac | Turkey | Ankara | Ankara |
| Marmara University Research and Training Hospital, Haematology Department | Tulin Tuglular | Turkey | Istanbul | Istanbul |
| Ege University Medical Faculty Hematology Department | Filiz Vural | Turkey | Izmir | Izmir |
| The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital | Supratik Basu | UK | England | Wolverhampton |
| University College London, Cancer Centre | Kwee Yong | UK | England | London |
| Churchill Hospital, Cancer and Haematology Centre | Karthik Ramasamy | UK | England | Oxford |
| Raigmore Hospital | Peter Forsyth | UK | Scotland | Inverness |
| Northwick Park Hospital | Charalampia Kyriakou | UK | England | Harrow |
| Guy's and St. Thomas' NHS Foundation Trust？ | Matthew Streetly | UK | England | London |
| Kent and Canterbury Hospital | Jindriska Lindsay | UK | England | Canterbury |
| Maidstone Hospital, Kent Oncology Centre | Saad Rassam | UK | England | Maidstone |
| Kharkiv Regional Clinical Oncology Center, Department of Hematology | Yuri Vinnyk | Ukraine | Kharkiv Oblast | Kharkiv |
| Cherkasy Regional Oncology Center | Halyna Pylypenko | Ukraine | Lviv Oblast | Cherkasy |
| Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre | Polina Kaplan | Ukraine | Dnipropetrovsk | Dnipropetrovsk |
| Kyiv Center for Bone Marrow Transplantation | Yevhen Karamanesht | Ukraine | Kyiv | Kyiv |
| O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center | Tamila Lysa | Ukraine | Zhytomyr Oblast | Zhytomyr |
| Institute of Blood Pathology and Transfusion Medicine | Zvenyslava Masliak | Ukraine | Lviv Oblast | Lviv |
| Khmelnytskyi Regional Hospital, Hematology Department | Grygoriy Rekhtman | Ukraine | Khmelnytskyi Oblast | Khmelnytskyi |
| M.I.Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department | Hanna Oliynyk | Ukraine | Vinnytsia Oblast | Vinnitsya |
| V.K. Husak Institute of Urgent and Reconstructive Surgery under the Ukrainian Academy of Medical Sciences, Hematology Department | Kateryna Vilchevska | Ukraine | Donetsk Oblast | Donetsk |
| Poltava M.V. Sklifosovskyi Regional Clinical Hospital, Department of Hematology | Igor Skrypnyk | Ukraine | Kharkiv Oblast | Poltava |
| Andrii Novak Zakarpattia Regional Clinical Hospital, Department of Hematology | Yurii Popovych | Ukraine | Zakarpattia Oblast | Uzhhorod |
| 浙江大学医学院附属第一医院 | 蔡真 | 中国 | 浙江省 | 杭州市 |
| 上海长征医院 | 侯健 | 中国 | 上海市 | 上海市 |
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伦理委员会 | 同意 | 2014-04-30 |
| 中国医学科学院血液病医院伦理委员会 | 同意 | 2014-06-17 |
| 中国医学科学院血液病医院伦理委员会 | 同意 | 2014-06-17 |
| 中国医学科学院血液病医院伦理委员会 | 同意 | |
| 中国医学科学院血液病医院伦理委员会 | 同意 |
试验状态信息
试验状态
进行中-招募完成
目标入组人数
国内: 计划入组约100 人；
国际: 入组882 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 102 人 ；
国际: 955 人；
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：登记人暂未填写该信息；
第一例受试者入组日期
国内：2014-08-12；
国际：2013-07-08；
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 |
|---|
