曼彻斯特Pomalidomide(Celgene)III期临床试验-Pomalidomide在骨髓纤维化受试者中的有效性和安全性的研究
曼彻斯特Mayo Clinic开展的Pomalidomide(Celgene)III期临床试验信息,需要患者受试者,主要适应症为MPN相关骨髓纤维化
登记号 | CTR20132070 | 试验状态 | 主动暂停 |
---|---|---|---|
申请人联系人 | 林侠 | 首次公示信息日期 | 2014-03-28 |
申请人名称 | 杭州泰格医药科技有限公司/ Celgene Corporation/ Penn Pharmaceutical Services Limited/ Fisher Clinical Services |
一、题目和背景信息
登记号 | CTR20132070 | ||
---|---|---|---|
相关登记号 | CTR20130078; | ||
药物名称 | Pomalidomide (Celgene) | ||
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 | MPN相关骨髓纤维化 | ||
试验专业题目 | 一项在患有骨髓增生性肿瘤相关性骨髓纤维化并对红细胞输注依赖的受试者中比较Pomalidomide的有效性和安全性的研究 | ||
试验通俗题目 | Pomalidomide在骨髓纤维化受试者中的有效性和安全性的研究 | ||
试验方案编号 | CC-4047-MF-002 | 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 |
二、申请人信息
申请人名称 |
1
2
3
4
|
||||
---|---|---|---|---|---|
联系人姓名 | 林侠 | 联系人座机 | 021-61339525 | 联系人手机号 | 暂无 |
联系人Email | hlin@celgene.com | 联系人邮政地址 | 上海市黄浦区南昌路45号城汇大厦21楼 | 联系人邮编 | 200020 |
三、临床试验信息
1、试验目的
比较pomalidomide与安慰剂在MPN相关性骨髓纤维化伴随红细胞输注依赖的患者中逆转红细胞输注依赖的有效性和安全性(全球试验)。MPN相关骨髓纤维化伴严重贫血但未接受红细胞输注的中国受试者中贫血的治疗反应(中国特定扩展试验) 2、试验设计
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 | 双盲 | 试验范围 | 国际多中心试验 |
3、受试者信息
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 |
|
||||||||||||||||||||||||||||||
排除标准 |
|
4、试验分组
试验药 |
|
||||||
---|---|---|---|---|---|---|---|
对照药 |
|
5、终点指标
主要终点指标及评价时间 |
|
||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
次要终点指标及评价时间 |
|
四、研究者信息
1、主要研究者信息
1 | 姓名 | Ayalew Tefferi, M.D. | 学位 | 暂无 | 职称 | NA |
---|---|---|---|---|---|---|
电话 | 507-284-2511 | tefferi.ayalew@mayo.edu | 邮政地址 | 200 First Street Southwest Rochester, MN | ||
邮编 | 55905 | 单位名称 | Mayo Clinic |
2、各参加机构信息
序号 | 机构名称 | 主要研究者 | 国家 | 省(州) | 城市 |
---|---|---|---|---|---|
1 | Mayo Clinic | Tefferi Ayalew | 美国 | MN | 曼彻斯特 |
2 | 中国医学科学院血液学研究所 | 肖志坚 | 中国 | 天津 | 天津 |
3 | 北京协和医院 | 周道斌 | 中国 | 北京 | 北京 |
4 | 北京大学人民医院 | 江倩 | 中国 | 北京 | 北京 |
5 | 江苏省人民医院 | 李建勇 | 中国 | 江苏 | 南京 |
6 | 瑞金医院 | 沈志祥 | 中国 | 上海 | 上海 |
7 | 华西医院 | 刘霆 | 中国 | 四川 | 成都 |
8 | Frankston Hospital, Oncology Day Unit | Edgar Jost | GERMANY | NORDRHEIN-WESTFALEN | Aachen |
9 | Gosford Hospital | Cecily Forsyth | AUSTRALIA | NSW | North Gosford |
10 | Gosford HospitaltCecilytForsythtAUSTRALIA North Gosford | William Stevenson | AUSTRALIA | NSW | Saint Leonards |
11 | The Royal Melbourne Hospital | Andrew Roberts | AUSTRALIA | VIC | Parkville |
12 | Medizinische Universitat Graz | Werner Linkesch | AUSTRIA | STYRIA | Graz |
13 | Medizinische Universitat Wien | Heinz Gisslinger | AUSTRIA | VIENNA | Wien |
14 | Medizinische Universitat Innsbruck | Gunther Gastl | AUSTRIA | TYROL | Innsbruck |
15 | Academisch Ziekenhuis Brugge | JanVan Droogenbroeck | BELGIUM | WEST-VLAANDEREN | Brugge |
16 | Grand Hopital de Charleroi | Philippe Mineur | BELGIUM | HAINAUT | Charleroi |
17 | Universitair Ziekenhuis Leuven | Timothy Devos | BELGIUM | FLEMISH BRABANT | Leuven |
18 | Ottawa General Hospital | Richard Van der Jagt | CANADA | ON | Ottawa |
19 | McMaster University Medical Centre | Brian Leber | CANADA | ON | Hamilton |
20 | Sir Mortimer B. Davis, Jewish General Hospital | Shireen Sirhan | CANADA | QC | Montreal |
21 | Centre Hospitalier de L'Universite de Montreal | Harold Olney | CANADA | QC | Montreal |
22 | Cross Cancer Institute, Dept. of Medical Oncology | Robert Turner | CANADA | AB | Edmonton |
23 | Princess Margaret Hospital | Vikas Gupta | CANADA | ON | Toronto |
24 | Vancouver General Hospital | Thomas Nevill | CANADA | BC | Vancouver |
25 | Centre Hospitalier Universitaire Limoges | Dominique Bordessoule | FRANCE | LIMOUSIN, LORRAINE | Limoges |
26 | Hopitaux Universitaire de Strasbourg -CHU | Shanti Ame | FRANCE | ALSACE | Strasbourg Cedex |
27 | Groupe Hospitalier de I'Institue Catholique de Lille-H?pital Saint-Vincent de Paul (Belfort) | Jean LouptDemory | FRANCE | NORD PAS-DE-CALAIS | Lille Cedex |
28 | Institut Gustave Roussy | Vincent Ribrag | FRANCE | ILE-DE-FRANCE | Villejuif Cedex |
29 | Hopital Saint Louis | Jean-Jacques Kiladjian | FRANCE | ILE DE FRANCE | Paris Cedex 10 |
30 | Hopital Purpan, Toulouse, Service Hematologie | ChristiantRecher | FRANCE | MIDI-PYRENEES | Toulouse Cedex 09 |
31 | Centre Hospitalier Universitaire Grenoble | Jean-YvestCahn | FRANCE | RHONE-ALPES | Grenoble Cedex |
32 | Groupe Hospitalier du Haut Leveque | Noel Milpied | FRANCE | AQUITAINE | Pessac Cedex |
33 | Medizinische Hochschule Hannover | Arnold Ganser | GERMANY | NIEDERSACHSEN | Hannover |
34 | Universitatsklinikum Aachen | Edgar Jost | GERMANY | NORDRHEIN-WESTFALEN | Aachen |
35 | Johannes-Wesling-Klinikum Minden | Martin Griesshammer | GERMANY | NORDRHEIN-WESTFALEN | Minden |
36 | Universitatsklinikum Leipzig | Haifa Kathrin Al-Ali | GERMANY | SACHSEN | Leipzig |
37 | Universitatsklinik Ulm | Richard Schlenk | GERMANY | BADEN-WUERTTEMBERG | Ulm |
38 | Azienda Ospedaliero-Univesitaria San Luigi Gonzaga | GiuseppetSaglio | ITALY | BARI | Orbassano |
39 | Azienda Ospedaliera Papa Giovanni XXIII | Alessandro Rambaldi | ITALY | BERGAMO | Bergamo |
40 | Azienda Ospedaliero-Universitaria Careggi | Alessandro Maria Vannucchi | ITALY | FIRENZE | Firenze |
41 | Azienda Ospedaliera Policlinico di Bari | Giorgina Specchia | ITALY | BARI | Bari |
42 | Fondazione IRCCS Policlinico S. Matteo | Mario Cazzola | ITALY | PAVIA | Pavia |
43 | Fondazione IRCCS Policlinico S. Matteo | GiovannitBarosi | ITALY | PAVIA | Pavia |
44 | Azienda Ospedaliera Universitaria Federico II | FabriziotPane | ITALY | NAPOLI | Napoli |
45 | Ospedale di Circolo e Fondazione Macchi | Francesco Passamonti | ITALY | VARESE | Varese |
46 | Juntendo University School of Medicine | Norio Komatsu | JAPAN | TOKYO | Bunkyou-ku |
47 | Kyoto University Hospital | HiroshitKawabata | JAPAN | KYOTO | Kyoto City |
48 | Nagasaki University Hospital | TomokotHata | JAPAN | NAGASAKI | Nagasaki City |
49 | Tokyo Medical University Hospital | KazumatOhyashiki | JAPAN | TOKYO | Shinjuku |
50 | Tokai University Hospital | KiyoshitAndo | JAPAN | KANAGAWA | Isehara City |
51 | Kyushu University Hospital | KatsutotTakenaka | JAPAN | FUKUOKA | Fukuoka City |
52 | Universitair Medisch Centrum Utrecht | ReiniertRaymakers | NETHERLANDS | UTRECHT | Utrecht |
53 | Erasmus Medisch Centrum | Petertte Boekhorst | NETHERLANDS | ZUID-HOLLAND | Rotterdam |
54 | Vrije Universiteit Medisch Centrum | SonjatZweegman | NETHERLANDS | NOORD-HOLLAND | Amsterdam |
55 | Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego PUM w Szczecinie | BarbaratZdziarska | POLAND | ZACHODNIOPOMORSKIE | Szczecin |
56 | Centralny Szpital Kliniczny MSW w Warszawie | AndrzejtDeptala | POLAND | MAZOWIECKIE | Warszawa |
57 | Wojewódzki Szpital Specjalistyczny im. Fryderyka Chopina w Rzeszowie | JolantatStarzak-Gwozdz | POLAND | PODKARPACKIE | Rzeszow |
58 | Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich | SebastiantGrosicki | POLAND | SLASKIE | Chorzow |
59 | Specjalistyczna Praktyka Lekarska | SebastiantGrosicki | POLAND | SLASKIE | Katowice |
60 | Hematology Scientific Center | MananatSokolova | RUSSIA | NA | Moscow |
61 | Saint Petersburg I.P. Pavlov State Medical University | GalinatSalogub | RUSSIA | ST. PETERSBURG | Saint Petersburg |
62 | FSI “V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies” | AndreytZaritskiy | RUSSIA | ST. PETERSBURG | Saint Petersburg |
63 | FGU Russian Scientific Research Institute of Hematology and Transfusiology | KudrattAbdulkadyrov | RUSSIA | ST. PETERSBURG | Saint Petersburg |
64 | Hospital Puerta de Hierro Majadahonda | EmiliotOjeda | SPAIN | MADRID | Majadahonda |
65 | Hospital Clínico Universitario de Salamanca | MariatDiez Campelo | SPAIN | SALAMANCA | Salamanca |
66 | Hospital Clinico Universitario de Valencia | Juan Carlos Hernandez Boluda | SPAIN | VALENICA | Valencia |
67 | Hospital Clinic I Provincial de Barcelona | FranciscotCervantes | SPAIN | BARCELONA | Barcelona |
68 | Karolinska University Hospital Huddinge | DanieltTesfa | SWEDEN | STOCKHOLM | Stockholm |
69 | Skanes Universitetssjukhus i Lund | LarstNilsson | SWEDEN | SKANE | Lund |
70 | Uddevalla Hospital | BjorntAndreasson | SWEDEN | VASTRA GOTALAND | Uddevalla |
71 | Sodersjukhuset | JantSamuelsson | SWEDEN | STOCKHOLM | Stockholm |
72 | Russells Hall Hospital | DavidtBareford | UNITED KINGDOM | ENGLAND | Dudley |
73 | Beatson Oncology Centre | MarktDrummond | UNITED KINGDOM | SCOTLAND | Glasgow |
74 | Freeman Hospital | JonathantWallis | UNITED KINGDOM | ENGLAND | Newcastle Upon Tyne |
75 | London Hammersmith Hospital | DraganatMilojkovic | UNITED KINGDOM | ENGLAND | London |
76 | Belfast City Hospital | MarytMcMullin | UNITED KINGDOM | NORTHERN IRELAND | Belfast |
77 | Royal Hallamshire Hospital | JohntReilly | UNITED KINGDOM | ENGLAND | Sheffield |
78 | Churchill Hospital | AdamtMead | UNITED KINGDOM | ENGLAND | Oxford |
79 | Guy's Hospital | ClairetHarrison | UNITED KINGDOM | ENGLAND | London |
80 | Weill Cornell Medical College | GailtRoboz | UNITED STATES | NY | New York |
81 | Columbia University Medical Center | AzratRaza | UNITED STATES | NY | New York |
82 | Mayo Clinic | AyalewtTefferi | UNITED STATES | MN | Rochester |
83 | University of Florida Shands Cancer Center | RandalltBrown | UNITED STATES | FL | Gainesville |
84 | University of Texas MD Anderson Cancer Center | SrdantVerstovsek | UNITED STATES | Texas | Houston |
85 | Avera Hematology and Transplant | KellytMcCaul | UNITED STATES | SD | Sioux Falls |
86 | Moffitt Cancer Center | RamitKomrokji | UNITED STATES | OH | Cincinnati |
87 | University of Michigan Comprehensive Cancer Center | MoshetTalpaz | UNITED STATES | MI | Ann Arbor |
88 | University of Utah Health Sciences Center | JoseftPrchal | UNITED STATES | UT | Salt Lake City |
89 | Jefferson Medical College | Emmanuel Besa | UNITED STATES | PA | Philadelphia |
90 | UCLA, School of Medicine, Div. of Hematology Oncology | GarytSchiller | UNITED STATES | CA | Los Angeles |
91 | Mayo Clinic Jacksonville | CandidotRivera | UNITED STATES | Florida | Jacksonville |
92 | University of Illinois at Chicago | DamianotRondelli | UNITED STATES | Illinois | Chicago |
93 | Fred Hutchinson Cancer Research Center | H. Joachim Deeg | UNITED STATES | WA | Seattle |
94 | Mount Sinai Hospital , The Donald H. Ruttenberg Cancer Treatment Center | John Mascarenhas | UNITED STATES | NY | New York |
95 | Memorial Sloan-Kettering Cancer Center | Raajit Rampal | UNITED STATES | NY | New York |
96 | Memorial Sloan-Kettering Cancer Center | Hugo Castro-Malaspina | UNITED STATES | NY | New York |
97 | Mayo Clinic Arizona | RubentMesa | UNITED STATES | AZ | Scottsdale |
98 | The Cleveland Clinic Foundation | RamontTiu | UNITED STATES | OH | Cleveland |
99 | The Cleveland Clinic Foundation | MikkaeltSekeres | UNITED STATES | OH | Cleveland |
100 | Edward Hines Jr. Veterns Affairs Hospital | NirmalatBhoopalam | UNITED STATES | Illinois | Hines |
101 | Brookdale Hopsital Medical Center | Jen ChintWang | UNITED STATES | NY | Brooklyn |
五、伦理委员会信息
序号 | 名称 | 审查结论 | 批准日期/备案日期 |
---|---|---|---|
1 | 上海瑞金医院伦理委员会 | 同意 | 2012-05-23 |
六、试验状态信息
1、试验状态
主动暂停
2、试验人数
目标入组人数 | 国内: 50-75 ; 国际: 210 ; |
---|---|
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: 36 ; 国际: 267 ; |
3、受试者招募及试验完成日期
第一例受试者签署知情同意书日期 | 国内:2012-05-24; 国际:2010-08-31; |
---|---|
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; |
TOP