Nemtabrutinib (MK-1026) 与比较药物(研究者选择的 Ibrutinib 或 Acalabrutinib)治疗一线 (1L) 慢性淋巴细胞白血病 (CLL)/小淋巴细胞淋巴瘤 (SLL) 的研究 (MK-1026-011/BELLWAVE-011)
在未经治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤受试者中比较 Nemtabrutinib 与对照药物(研究者选择的 Ibrutinib 或 Acalabrutinib)的 3 期随机研究 (BELLWAVE-011)
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
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Anhui
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Hefei、Anhui、中国、230031
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100034
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接触:
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Beijing、Beijing Municipality、中国、100191
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接触:
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400030
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Guangdong
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Guangzhou、Guangdong、中国、510515
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- Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
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Guangzhou、Guangdong、中国、510060
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Guangxi
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Liuzhou、Guangxi、中国、545006
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Nanning、Guangxi、中国、530200
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Guizhou
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Guiyang、Guizhou、中国、550004
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Hainan
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Haikou、Hainan、中国、570311
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Zhengzhou、Henan、中国、450008
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Wuhan、Hubei、中国、430000
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Wuhan、Hubei、中国、430058
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Changsha、Hunan、中国、410011
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Changsha、Hunan、中国、410006
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Nanjing、Jiangsu、中国、210029
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Suzhou、Jiangsu、中国、215000
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Xuzhou、Jiangsu、中国、221006
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Jiangxi
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Nanchang、Jiangxi、中国、330006
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Nanchang、Jiangxi、中国、330029
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Jilin
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Changchun、Jilin、中国、130021
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Shaanxi
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Xi'an、Shaanxi、中国、710068
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Shandong
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Jinan、Shandong、中国、250117
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Shanxi
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Taiyuan、Shanxi、中国、030000
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Sichuan
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Chengdu、Sichuan、中国、610041
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300060
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Aalborg、North Denmark、丹麦、9000
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Koege、Region Sjælland、丹麦、4600
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Region Syddanmark
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Odense C、Region Syddanmark、丹麦、5000
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Haifa、以色列、3109601
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Haifa、以色列、3339419
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Jerusalem、以色列、9112001
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Petah Tikva、以色列、4941492
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Ramat Gan、以色列、5265601
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Tsrifin、以色列、7033001
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Brampton、Ontario、加拿大、L6R 3J7
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Rimouski、Quebec、加拿大、G5L 5T1
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Gauteng
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Johannesburg、Gauteng、南非、1864
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Pretoria、Gauteng、南非、0181
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Western Cape
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Cape Town、Western Cape、南非、7925
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Kuilsriver、Western Cape、南非、7580
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Plumstead、Western Cape、南非、7800
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Kaohsiung City、台湾、833
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Tainan、台湾、704302
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Taipei、台湾、10048
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Taoyuan、台湾、33305
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Cesar Department
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Valledupar、Cesar Department、哥伦比亚、200001
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Departamento de Córdoba
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Montería、Departamento de Córdoba、哥伦比亚、230002
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Valle del Cauca Department
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Cali、Valle del Cauca Department、哥伦比亚、760032
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Ankara、土耳其(türkiye)、06100
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接触:
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Ankara、土耳其(türkiye)、06800
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Antalya、土耳其(türkiye)、7100
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Edirne、土耳其(türkiye)、22030
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Istanbul、土耳其(türkiye)、34214
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接触:
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Istanbul、土耳其(türkiye)、34381
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Istanbul、土耳其(türkiye)、34899
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Izmir、土耳其(türkiye)、35100
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Samsun、土耳其(türkiye)、55280
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Mexico City
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Benito Juárez、Mexico City、墨西哥、03100
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Mexico City、Mexico City、墨西哥、03100
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Mexico City、Mexico City、墨西哥、03100
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Rio de Janeiro、巴西、20230-130
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São Paulo、巴西、01321-001
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Paraná
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Curitiba、Paraná、巴西、81520-060
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São Paulo
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Ribeirão Preto、São Paulo、巴西、14026-610
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接触:
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São Paulo、São Paulo、巴西、01409-001
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接触:
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Ioannina、希腊、455 00
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接触:
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Attica
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Athens、Attica、希腊、106 76
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接触:
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Athens、Attica、希腊、115 26
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East Macedonia and Thrace
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Alexandroupoli、East Macedonia and Thrace、希腊、681 00
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接触:
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Berlin、德国、10707
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接触:
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Baden-Wurttemberg
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Ulm、Baden-Wurttemberg、德国、89081
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接触:
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Bavaria
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Landshut、Bavaria、德国、84036
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接触:
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North Rhine-Westphalia
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Mönchengladbach、North Rhine-Westphalia、德国、41063
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接触:
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Rhineland-Palatinate
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Koblenz、Rhineland-Palatinate、德国、56068
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接触:
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Saxony-Anhalt
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Halle、Saxony-Anhalt、德国、06120
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接触:
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Oslo、挪威、0372
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接触:
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Akershus
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Lørenskog、Akershus、挪威、1474
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接触:
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Vestfold
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Tønsberg、Vestfold、挪威、3103
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接触:
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Hradec Králové、捷克语、500 05
- 招聘中
- Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
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接触:
- Study Coordinator
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Olomouc、捷克语、779 00
- 招聘中
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接触:
- Study Coordinator
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Prague、捷克语、128 08
- 招聘中
- Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
-
接触:
- Study Coordinator
- 电话号码:+420224962527
-
-
-
-
-
Auckland、新西兰、0622
- 招聘中
- North Shore Hospital-Department of Haematology ( Site 3200)
-
接触:
- Study Coordinator
- 电话号码:+64 9 486 8930
-
Auckland、新西兰、2025
- 招聘中
- Aotearoa Clinical Trials ( Site 3201)
-
接触:
- Study Coordinator
- 电话号码:(+64)0800272784
-
-
Waikato Region
-
Hamilton、Waikato Region、新西兰、3240
- 招聘中
- Waikato Hospital-Haematology ( Site 3202)
-
接触:
- Study Coordinator
- 电话号码:+64 7 839 8899
-
-
-
-
-
Chiba、日本、260-8717
- 主动,不招人
- Chiba Cancer Center ( Site 1905)
-
Fukuoka、日本、812-8582
- 完全的
- Kyushu University Hospital ( Site 1914)
-
Hiroshima、日本、730-8619
- 主动,不招人
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
-
Okayama、日本、700-8558
- 主动,不招人
- Okayama University Hospital ( Site 1912)
-
Osaka、日本、543-8555
- 主动,不招人
- Japanese Red Cross Osaka Hospital ( Site 1908)
-
Yamagata、日本、990-9585
- 主动,不招人
- Yamagata University Hospital ( Site 1902)
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、466-8560
- 主动,不招人
- Nagoya University Hospital ( Site 1907)
-
-
Gunma
-
Maebashi、Gunma、日本、371-8511
- 主动,不招人
- Gunma University Hospital ( Site 1903)
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、060-8648
- 主动,不招人
- Hokkaido University Hospital ( Site 1900)
-
-
Hyōgo
-
Kobe、Hyōgo、日本、650-0047
- 主动,不招人
- Kobe City Medical Center General Hospital ( Site 1910)
-
-
Miyagi
-
Sendai、Miyagi、日本、980-8574
- 主动,不招人
- Tohoku University Hospital ( Site 1901)
-
-
Osaka
-
Sakai、Osaka、日本、590-0197
- 主动,不招人
- Kindai University Hospital ( Site 1909)
-
-
Shimane
-
Izumo、Shimane、日本、693-8501
- 主动,不招人
- Shimane University Hospital ( Site 1911)
-
-
Tokyo
-
Koto、Tokyo、日本、135-8550
- 主动,不招人
- Cancer Institute Hospital of JFCR ( Site 1906)
-
-
-
-
Region M. de Santiago
-
Santiago、Region M. de Santiago、智利、7500921
- 招聘中
- FALP-UIDO ( Site 2300)
-
接触:
- Study Coordinator
- 电话号码:56224205098
-
Santiago、Region M. de Santiago、智利、7650568
- 招聘中
- Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
-
接触:
- Study Coordinator
- 电话号码:56222101111 (6218)
-
Santiago、Region M. de Santiago、智利、8420383
- 招聘中
- Bradfordhill-Clinical Area ( Site 2310)
-
接触:
- Study Coordinator
- 电话号码:56229490970
-
-
-
-
Antwerpen
-
Mechelen、Antwerpen、比利时、2800
- 招聘中
- AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
-
接触:
- Study Coordinator
- 电话号码:+3215892080
-
-
Vlaams-Brabant
-
Leuven、Vlaams-Brabant、比利时、3000
- 招聘中
- UZ Leuven-Hematology ( Site 0200)
-
接触:
- Study Coordinator
- 电话号码:+3216332211
-
-
-
-
Lesser Poland Voivodeship
-
Krakow、Lesser Poland Voivodeship、波兰、30-727
- 招聘中
- Pratia MCM Krakow ( Site 1007)
-
接触:
- Study Coordinator
- 电话号码:0048602338290
-
-
Lublin Voivodeship
-
Lublin、Lublin Voivodeship、波兰、20-081
- 招聘中
- Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
-
接触:
- Study Coordinator
- 电话号码:+48 81 534 54 68
-
-
Masovian Voivodeship
-
Warsaw、Masovian Voivodeship、波兰、02-781
- 招聘中
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
-
接触:
- Study Coordinator
- 电话号码:+48225462223
-
-
Pomeranian Voivodeship
-
Gdansk、Pomeranian Voivodeship、波兰、80-214
- 招聘中
- Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
-
接触:
- Study Coordinator
- 电话号码:+48 58 584 43 57
-
Słupsk、Pomeranian Voivodeship、波兰、76-200
- 完全的
- Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
-
-
Silesian Voivodeship
-
Gliwice、Silesian Voivodeship、波兰、44-102
- 招聘中
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
-
接触:
- Study Coordinator
- 电话号码:+48322788523
-
Katowice、Silesian Voivodeship、波兰、40-519
- 招聘中
- Pratia Onkologia Katowice ( Site 1009)
-
接触:
- Study Coordinator
- 电话号码:+48501714019
-
-
Warmian-Masurian Voivodeship
-
Olsztyn、Warmian-Masurian Voivodeship、波兰、10-228
- 招聘中
- Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
-
接触:
- Study Coordinator
- 电话号码:48895398133
-
-
-
-
Bangkok
-
Bangkok、Bangkok、泰国、10700
- 招聘中
- Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
-
接触:
- Study Coordinator
- 电话号码:+6624197767
-
Pathumwan、Bangkok、泰国、10330
- 招聘中
- Chulalongkorn University ( Site 1802)
-
接触:
- Study Coordinator
- 电话号码:+6624197767
-
-
Changwat Phitsanulok
-
Muang、Changwat Phitsanulok、泰国、65000
- 招聘中
- Naresuan University Hospital ( Site 1804)
-
接触:
- Study Coordinator
- 电话号码:+6655965777
-
-
Changwat Songkhla
-
Hat Yai、Changwat Songkhla、泰国、90110
- 招聘中
- Songklanagarind hospital ( Site 1803)
-
接触:
- Study Coordinator
- 电话号码:6674451735
-
-
Chiang Mai
-
Muang、Chiang Mai、泰国、50200
- 招聘中
- Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
-
接触:
- Study Coordinator
- 电话号码:6653935488
-
-
-
-
New South Wales
-
St Leonards、New South Wales、澳大利亚、2065
- 完全的
- Royal North Shore Hospital ( Site 2806)
-
-
-
-
Stockholm County
-
Stockholm、Stockholm County、瑞典、171 64
- 招聘中
- Karolinska Universitetssjukhuset Solna ( Site 1302)
-
接触:
- Study Coordinator
- 电话号码:+46812370000
-
-
-
-
-
Lima、秘鲁、15073
- 招聘中
- Clínica Anglo Americana ( Site 2701)
-
接触:
- Study Coordinator
- 电话号码:+5116168900
-
-
Ariqipa
-
Arequipa、Ariqipa、秘鲁、054
- 招聘中
- Centro Medico Monte Carmelo-Oncology ( Site 2706)
-
接触:
- Study Coordinator
- 电话号码:+51980728089
-
-
-
-
Alabama
-
Mobile、Alabama、美国、36604
- 招聘中
- USA Mitchell Cancer Institute ( Site 0014)
-
接触:
- Study Coordinator
- 电话号码:251-665-8000
-
-
Arizona
-
Gilbert、Arizona、美国、85234
- 招聘中
- Banner MD Anderson Cancer Center ( Site 0059)
-
接触:
- Study Coordinator
- 电话号码:480-256-5490
-
Phoenix、Arizona、美国、85006
- 招聘中
- Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
-
接触:
- Study Coordinator
- 电话号码:480-256-5490
-
Prescott、Arizona、美国、86301
- 完全的
- Arizona Oncology Associates - NAHOA ( Site 8007)
-
-
California
-
Berkeley、California、美国、94704
- 主动,不招人
- Alta Bates Summit Medical Center ( Site 0004)
-
La Jolla、California、美国、92093-0698
- 招聘中
- Moores Cancer Center ( Site 0003)
-
接触:
- Study Coordinator
- 电话号码:858-534-5201
-
Pasadena、California、美国、91105
- 招聘中
- Care Access - South Pasadena ( Site 0070)
-
接触:
- Study Coordinator
- 电话号码:626-556-9930
-
-
Colorado
-
Denver、Colorado、美国、80218
- 招聘中
- Saint Joseph Hospital ( Site 0026)
-
接触:
- Study Coordinator
- 电话号码:303-403-6381
-
Golden、Colorado、美国、80401
- 招聘中
- Lutheran Medical Center ( Site 0027)
-
接触:
- Study Coordinator
- 电话号码:303-403-6381
-
Grand Junction、Colorado、美国、81501
- 招聘中
- Intermountain Health St. Mary's Regional Hospital ( Site 0025)
-
接触:
- Study Coordinator
- 电话号码:970-298-7638
-
-
Connecticut
-
Norwich、Connecticut、美国、06360
- 招聘中
- Eastern CT Hematology & Oncology Associates ( Site 0033)
-
接触:
- Study Coordinator
- 电话号码:860-886-8362
-
-
Florida
-
Boca Raton、Florida、美国、33486
- 招聘中
- Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
-
接触:
- Study Coordinator
- 电话号码:561-955-4800
-
Clermont、Florida、美国、34711
- 招聘中
- Clermont Oncology Center ( Site 0046)
-
接触:
- Study Coordinator
- 电话号码:386-538-3169
-
Fort Myers、Florida、美国、33901
- 招聘中
- Florida Cancer Specialists - South ( Site 7001)
-
接触:
- Study Coordinator
- 电话号码:239-274-9930
-
West Palm Beach、Florida、美国、33401
- 招聘中
- Florida Cancer Specialists - East ( Site 7002)
-
接触:
- Study Coordinator
- 电话号码:727-216-1143
-
-
Idaho
-
Boise、Idaho、美国、83706
- 招聘中
- Saint Alphonsus Regional Medical Center ( Site 0067)
-
接触:
- Study Coordinator
- 电话号码:208-367-3131
-
-
Indiana
-
Fort Wayne、Indiana、美国、46845
- 招聘中
- Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
-
接触:
- Study Coordinator
- 电话号码:260-266-7100
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- 招聘中
- University of Iowa Health Care. ( Site 0017)
-
接触:
- Study Coordinator
- 电话号码:319-356-1616
-
Waukee、Iowa、美国、50263
- 招聘中
- University of Iowa Health Care. ( Site 0057)
-
接触:
- Study Coordinator
- 电话号码:319-356-1616
-
-
Kentucky
-
Edgewood、Kentucky、美国、41017
- 招聘中
- Saint Elizabeth Healthcare ( Site 0041)
-
接触:
- Study Coordinator
- 电话号码:859-301-2000
-
Owensboro、Kentucky、美国、42303
- 招聘中
- Owensboro Medical Health System ( Site 0066)
-
接触:
- Study Coordinator
- 电话号码:270-688-1938
-
-
Michigan
-
Grand Rapids、Michigan、美国、49503
- 招聘中
- Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
-
接触:
- Study Coordinator
- 电话号码:616-267-7566
-
-
Minnesota
-
Saint Louis Park、Minnesota、美国、55416
- 招聘中
- Regions Hospital ( Site 0042)
-
接触:
- Study Coordinator
- 电话号码:952-993-3252
-
-
Missouri
-
Kansas City、Missouri、美国、64132
- 招聘中
- MidAmerica Cancer Care, LLC ( Site 0043)
-
接触:
- Study Coordinator
- 电话号码:816-974-5050
-
-
Montana
-
Billings、Montana、美国、59102
- 招聘中
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
-
接触:
- Study Coordinator
- 电话号码:406-238-6685
-
-
New Jersey
-
Florham Park、New Jersey、美国、07932
- 完全的
- Summit Medical Group Cancer Center ( Site 0007)
-
Hackensack、New Jersey、美国、07601
- 招聘中
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
-
接触:
- Study Coordinator
- 电话号码:551-996-3277
-
-
New York
-
Albany、New York、美国、12208
- 招聘中
- New York Oncology Hematology, P.C. ( Site 0069)
-
接触:
- Study Coordinator
- 电话号码:518-262-6696
-
Buffalo、New York、美国、14263
- 招聘中
- Roswell Park Cancer Institute ( Site 0023)
-
接触:
- Study Coordinator
- 电话号码:716-845-2300
-
Williamsville、New York、美国、14221
- 招聘中
- RPCI Oncology, PC- Northtowns ( Site 0061)
-
接触:
- Study Coordinator
- 电话号码:716-634-3340
-
-
North Carolina
-
Charlotte、North Carolina、美国、28207
- 招聘中
- Carolina Oncology Specialists, PA ( Site 0054)
-
接触:
- Study Coordinator
- 电话号码:704-342-1900
-
Goldsboro、North Carolina、美国、27534
- 招聘中
- Southeastern Medical Oncology Center ( Site 0049)
-
接触:
- Study Coordinator
- 电话号码:919-587-9088
-
-
Pennsylvania
-
Broomall、Pennsylvania、美国、19008
- 招聘中
- Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
-
接触:
- Study Coordinator
- 电话号码:610-585-6287
-
York、Pennsylvania、美国、17403
- 招聘中
- Cancer Care Associates Of York ( Site 0005)
-
接触:
- Study Coordinator
- 电话号码:717-741-9229
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37404
- 招聘中
- Tennessee Oncology-Chattanooga ( Site 0045)
-
接触:
- Study Coordinator
- 电话号码:615-986-4350
-
Nashville、Tennessee、美国、37203
- 招聘中
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
-
接触:
- Study Coordinator
- 电话号码:615-986-4350
-
-
Texas
-
Austin、Texas、美国、78705
- 招聘中
- Texas Oncology - Central/South Texas ( Site 8008)
-
接触:
- Study Coordinator
- 电话号码:512-421-4100
-
Fort Worth、Texas、美国、76104
- 招聘中
- The Center for Cancer and Blood Disorders ( Site 0032)
-
接触:
- Study Coordinator
- 电话号码:817-759-7013
-
San Antonio、Texas、美国、78217
- 招聘中
- Texas Oncology - San Antonio ( Site 8006)
-
接触:
- Study Coordinator
- 电话号码:210-419-2608
-
Tyler、Texas、美国、75702
- 招聘中
- Texas Oncology - Northeast Texas ( Site 8012)
-
接触:
- Study Coordinator
- 电话号码:903-579-9800
-
-
Virginia
-
Charlottesville、Virginia、美国、22903
- 招聘中
- University of Virginia Cancer Center ( Site 0040)
-
接触:
- Study Coordinator
- 电话号码:434-243-2649
-
Fairfax、Virginia、美国、22031
- 招聘中
- Inova Schar Cancer Institute ( Site 0015)
-
接触:
- Study Coordinator
- 电话号码:571-472-4724
-
Richmond、Virginia、美国、23298
- 招聘中
- Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
-
接触:
- Study Coordinator
- 电话号码:804-628-2072
-
-
Washington
-
Edmonds、Washington、美国、98026
- 招聘中
- Swedish Cancer Institute, Edmonds Campus ( Site 0072)
-
接触:
- Study Coordinator
- 电话号码:206-215-3100
-
Issaquah、Washington、美国、98029
- 招聘中
- Swedish Cancer Institute, Issaquah Campus ( Site 0073)
-
接触:
- Study Coordinator
- 电话号码:206-215-3100
-
Seattle、Washington、美国、98104
- 招聘中
- Swedish Medical Center-Swedish Cancer Institute ( Site 0071)
-
接触:
- Study Coordinator
- 电话号码:206-215-3100
-
Spokane、Washington、美国、99208
- 招聘中
- Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
-
接触:
- Study Coordinator
- 电话号码:509-462-2273
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- 招聘中
- University Hospital and UW Health Clinics ( Site 0006)
-
接触:
- Study Coordinator
- 电话号码:608-263-6400
-
Madison、Wisconsin、美国、53715
- 招聘中
- SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
-
接触:
- Study Coordinator
- 电话号码:608-410-2700
-
-
-
-
-
Barnet、英国、EN5 3DJ
- 招聘中
- Barnet Hospital ( Site 3005)
-
接触:
- Study Coordinator
- 电话号码:0208 216 4755
-
Leeds、英国、LS9 7TF
- 招聘中
- St James's University Hospital ( Site 3004)
-
接触:
- Study Coordinator
- 电话号码:+441132432799
-
Nottingham、英国、NG5 1PB
- 完全的
- City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
-
-
Bristol, City of
-
Bristol、Bristol, City of、英国、BS10 5NB
- 完全的
- Southmead Hospital ( Site 3010)
-
-
Lancashire
-
Lancaster、Lancashire、英国、LA1 4RP
- 完全的
- Royal Lancaster Infirmary ( Site 3012)
-
-
London, City of
-
London、London, City of、英国、EC1A 7BE
- 招聘中
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
-
接触:
- Study Coordinator
- 电话号码:+442073777000
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX3 7LE
- 招聘中
- The Churchill Hospital ( Site 3007)
-
接触:
- Study Coordinator
- 电话号码:441865235886
-
-
South Gloucestershire
-
Bristol、South Gloucestershire、英国、BS32 4SY
- 招聘中
- GenesisCare - Bristol ( Site 3011)
-
接触:
- Study Coordinator
- 电话号码:+441173421121
-
-
Suffolk
-
Newmarket、Suffolk、英国、CB8 7XN
- 招聘中
- GenesisCare - Cambridge ( Site 3001)
-
接触:
- Study Coordinator
- 电话号码:01223 907622
-
-
Windsor And Maidenhead
-
Windsor、Windsor And Maidenhead、英国、SL4 3HD
- 招聘中
- GenesisCare - Windsor ( Site 3002)
-
接触:
- Study Coordinator
- 电话号码:447989474250
-
-
-
-
-
Lisbon、葡萄牙、1449-005
- 招聘中
- Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
-
接触:
- Study Coordinator
- 电话号码:00351210431703
-
Lisbon、葡萄牙、1649-035
- 招聘中
- Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
-
接触:
- Study Coordinator
- 电话号码:+351217805000
-
Porto、葡萄牙、4200-072
- 招聘中
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
-
接触:
- Study Coordinator
- 电话号码:00351225084000
-
-
Lisbon District
-
Lisbon、Lisbon District、葡萄牙、1099-023
- 招聘中
- Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
-
接触:
- Study Coordinator
- 电话号码:00351217229800
-
Lisbon、Lisbon District、葡萄牙、1400-038
- 招聘中
- Champalimaud Foundation ( Site 3102)
-
接触:
- Study Coordinator
- 电话号码:00351210480200
-
-
Porto District
-
Vila Nova de Gaia、Porto District、葡萄牙、4434-502
- 招聘中
- Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
-
接触:
- Study Coordinator
- 电话号码:00351227865100
-
-
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Barcelona、西班牙、08035
- 招聘中
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
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接触:
- Study Coordinator
- 电话号码:+34 934893806
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Salamanca、西班牙、37007
- 招聘中
- Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
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接触:
- Study Coordinator
- 电话号码:923291100 Ext. 55014
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Barcelona
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L'Hospitalet Del Llobregat、Barcelona、西班牙、08908
- 招聘中
- Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
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接触:
- Study Coordinator
- 电话号码:+ 34 932607750
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Catalonia
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Barcelona、Catalonia、西班牙、08036
- 招聘中
- HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
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接触:
- Study Coordinator
- 电话号码:+34 619085109
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Madrid
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Pozuelo de Alarcón、Madrid、西班牙、28223
- 招聘中
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
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接触:
- Study Coordinator
- 电话号码:+34 914521900
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Madrid, Comunidad de
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Majadahonda、Madrid, Comunidad de、西班牙、28222
- 招聘中
- HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
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接触:
- Study Coordinator
- 电话号码:+34 911917620
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Santa Cruz De Tenerife
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San Cristóbal de La Laguna、Santa Cruz De Tenerife、西班牙、38320
- 招聘中
- hospital universitario de canarias ( Site 1205)
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接触:
- Study Coordinator
- 电话号码:+34922678207
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Hong Kong、香港
- 招聘中
- Queen Mary Hospital ( Site 3300)
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接触:
- Study Coordinator
- 电话号码:+852 2255 3838
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Kuala Lumpur
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Lembah Pantai、Kuala Lumpur、马来西亚、59100
- 招聘中
- University Malaya Medical Centre ( Site 1604)
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接触:
- Study Coordinator
- 电话号码:+60479492351
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Pulau Pinang
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George Town、Pulau Pinang、马来西亚、10450
- 招聘中
- Hospital Pulau Pinang ( Site 1602)
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接触:
- Study Coordinator
- 电话号码:+6042225767
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Sabah
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Kota Kinabalu、Sabah、马来西亚、88586
- 招聘中
- Queen Elizabeth Hospital ( Site 1603)
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接触:
- Study Coordinator
- 电话号码:+6088517555
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
- Has at least 1 marker of disease burden.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
- Has the ability to swallow and retain oral medication.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
- Has clinically significant cardiovascular disease.
- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
- Has history of severe bleeding disorder.
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has received any systemic anticancer therapy for CLL/SLL.
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
- Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Nemtabrutinib
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
Administered orally
其他名称:
|
|
有源比较器:Ibrutinib/Acalabrutinib
Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
Administered orally Administered orally |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
大体时间:Up to approximately 44 months
|
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR. |
Up to approximately 44 months
|
|
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
大体时间:Up to approximately 104 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR. |
Up to approximately 104 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间:Up to approximately 104 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 104 months
|
|
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
大体时间:Up to approximately 104 months
|
For participants who demonstrate a complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR) per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first. |
Up to approximately 104 months
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
大体时间:Up to approximately 104 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 104 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间:Up to approximately 104 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 104 months
|
合作者和调查者
调查人员
- 研究主任:Medical Director、Merck Sharp & Dohme LLC
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1026-011
- U1111-1281-7895 (注册表标识符:UTN)
- MK-1026-011 (其他标识符:MSD)
- BELLWAVE-011 (其他标识符:MSD)
- jRCT2031230697 (注册表标识符:jRCT)
- 2022-501697-19-00 (注册表标识符:EU CT)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.