- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06136559
Een onderzoek naar Nemtabrutinib (MK-1026) versus comparator (keuze van de onderzoeker: Ibrutinib of Acalabrutinib) in eerstelijns (1L) chronische lymfatische leukemie (CLL)/klein lymfatisch lymfoom (SLL) (MK-1026-011/BELLWAVE-011)
Een gerandomiseerde fase 3-studie om Nemtabrutinib te vergelijken met een comparator (keuze van de onderzoeker: Ibrutinib of Acalabrutinib) bij deelnemers met onbehandelde chronische lymfatische leukemie/klein lymfatisch lymfoom (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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Toll Free Number
- Telefoonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studie Locaties
-
-
New South Wales
-
St Leonards, New South Wales, Australië, 2065
- Voltooid
- Royal North Shore Hospital ( Site 2806)
-
-
-
-
Antwerpen
-
Mechelen, Antwerpen, België, 2800
- Werving
- AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
-
Contact:
- Study Coordinator
- Telefoonnummer: +3215892080
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, België, 3000
- Werving
- UZ Leuven-Hematology ( Site 0200)
-
Contact:
- Study Coordinator
- Telefoonnummer: +3216332211
-
-
-
-
-
Rio de Janeiro, Brazilië, 20230-130
- Werving
- Instituto Nacional de Câncer - INCA ( Site 2201)
-
Contact:
- Study Coordinator
- Telefoonnummer: +2132076585
-
São Paulo, Brazilië, 01321-001
- Werving
- Hospital Paulistano-Americas Oncologia ( Site 2202)
-
Contact:
- Study Coordinator
- Telefoonnummer: 55 11 11 3141-1083
-
-
Paraná
-
Curitiba, Paraná, Brazilië, 81520-060
- Werving
- Hospital Erasto Gaertner ( Site 2212)
-
Contact:
- Study Coordinator
- Telefoonnummer: +55 (41) 33615195
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazilië, 14026-610
- Werving
- Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 2211)
-
Contact:
- Study Coordinator
- Telefoonnummer: +55 16 98813-0059
-
São Paulo, São Paulo, Brazilië, 01409-001
- Werving
- Hospital 9 De Julho ( Site 2206)
-
Contact:
- Study Coordinator
- Telefoonnummer: 55 11 3147 9432
-
-
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y 5L3
- Werving
- BC Cancer Kelowna ( Site 0112)
-
Contact:
- Study Coordinator
- Telefoonnummer: 250-717-4294
-
Victoria, British Columbia, Canada, V8R 6V5
- Werving
- BC Cancer Victoria ( Site 0109)
-
Contact:
- Study Coordinator
- Telefoonnummer: 250-519-5500
-
-
Ontario
-
Brampton, Ontario, Canada, L6R 3J7
- Werving
- William Osler Health System ( Site 0103)
-
Contact:
- Study Coordinator
- Telefoonnummer: 905-494-2120
-
Ottawa, Ontario, Canada, K1H 8L6
- Werving
- The Ottawa Hospital - General Campus ( Site 0102)
-
Contact:
- Study Coordinator
- Telefoonnummer: 613-737-8899 x79509
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Werving
- McGill University Health Centre ( Site 0106)
-
Contact:
- Study Coordinator
- Telefoonnummer: 514-934-1934
-
Rimouski, Quebec, Canada, G5L 5T1
- Voltooid
- Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
-
-
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chili, 7500921
- Werving
- FALP-UIDO ( Site 2300)
-
Contact:
- Study Coordinator
- Telefoonnummer: 56224205098
-
Santiago, Region M. de Santiago, Chili, 7650568
- Werving
- Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
-
Contact:
- Study Coordinator
- Telefoonnummer: 56222101111 (6218)
-
Santiago, Region M. de Santiago, Chili, 8420383
- Werving
- Bradfordhill-Clinical Area ( Site 2310)
-
Contact:
- Study Coordinator
- Telefoonnummer: 56229490970
-
-
-
-
Anhui
-
Hefei, Anhui, China, 230031
- Werving
- Anhui Provincial Cancer Hospital ( Site 2001)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0551-65329163
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100034
- Werving
- Peking University First Hospital ( Site 2022)
-
Contact:
- Study Coordinator
- Telefoonnummer: 010-83575680
-
Beijing, Beijing Municipality, China, 100191
- Werving
- Peking University Third Hospital-Hematology ( Site 2011)
-
Contact:
- Study Coordinator
- Telefoonnummer: 010-82264404
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 400030
- Werving
- Chongqing University Cancer Hospital ( Site 2041)
-
Contact:
- Study Coordinator
- Telefoonnummer: 02365079270
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Werving
- Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
-
Contact:
- Study Coordinator
- Telefoonnummer: +86 02062786845
-
Guangzhou, Guangdong, China, 510060
- Werving
- Sun Yat-sen University Cancer Center ( Site 2028)
-
Contact:
- Study Coordinator
- Telefoonnummer: 020-87343886
-
-
Guangxi
-
Liuzhou, Guangxi, China, 545006
- Werving
- Liuzhou People's Hospital ( Site 2029)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0772-3612345
-
Nanning, Guangxi, China, 530200
- Werving
- Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0771-5313603
-
-
Guizhou
-
Guiyang, Guizhou, China, 550004
- Werving
- The Affiliated Hospital of Guizhou Medical University ( Site 2024)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0851-86740793
-
-
Hainan
-
Haikou, Hainan, China, 570311
- Werving
- Hainan General Hospital ( Site 2018)
-
Contact:
- Study Coordinator
- Telefoonnummer: (0898)68622479
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Werving
- Henan Cancer Hospital-hematology department ( Site 2025)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0371-65587305
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Werving
- Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
-
Contact:
- Study Coordinator
- Telefoonnummer: 02783662640
-
Wuhan, Hubei, China, 430058
- Werving
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015)
-
Contact:
- Study Coordinator
- Telefoonnummer: 02784397521
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Werving
- The Second Xiangya Hospital of Central South University ( Site 2010)
-
Contact:
- Study Coordinator
- Telefoonnummer: +86 073185292097
-
Changsha, Hunan, China, 410006
- Werving
- Hunan Cancer Hospital ( Site 2020)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0731-89762281
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Werving
- Jiangsu Province Hospital ( Site 2000)
-
Contact:
- Study Coordinator
- Telefoonnummer: 025-68307358
-
Suzhou, Jiangsu, China, 215000
- Werving
- The First Affliated Hospital of Suzhou University ( Site 2027)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0512-67972858
-
Xuzhou, Jiangsu, China, 221006
- Werving
- The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
-
Contact:
- Study Coordinator
- Telefoonnummer: 051685802369
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Werving
- The First Affiliated Hospital of Nanchang University ( Site 2023)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0791-88695051
-
Nanchang, Jiangxi, China, 330029
- Werving
- Jiangxi Provincial Cancer Hospital ( Site 2009)
-
Contact:
- Study Coordinator
- Telefoonnummer: 079188329441
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Werving
- The First Hospital of Jilin University-Hematology ( Site 2030)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0431-81879901
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710068
- Werving
- Shaanxi provincial people's hospital ( Site 2012)
-
Contact:
- Study Coordinator
- Telefoonnummer: 029-85251331
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Werving
- Shandong Cancer Hospital ( Site 2003)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0531-87984777
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030000
- Werving
- Shanxi Cancer Hospital ( Site 2033)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0351-4651037
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Werving
- West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
-
Contact:
- Study Coordinator
- Telefoonnummer: 02885423278
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300060
- Werving
- Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
-
Contact:
- Study Coordinator
- Telefoonnummer: 022-23340123-2071
-
Tianjin, Tianjin Municipality, China, 301617
- Werving
- Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
-
Contact:
- Study Coordinator
- Telefoonnummer: 022-23608110
-
-
Xinjiang
-
Ürümqi, Xinjiang, China, 830000
- Werving
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0991-7968088
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Werving
- Zhejiang Cancer Hospital ( Site 2017)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0571-88122198
-
Hangzhou, Zhejiang, China, 310003
- Werving
- The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
-
Contact:
- Study Coordinator
- Telefoonnummer: 057187236114
-
-
-
-
Cesar Department
-
Valledupar, Cesar Department, Colombia, 200001
- Werving
- Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
-
Contact:
- Study Coordinator
- Telefoonnummer: +57 315 8505190
-
-
Departamento de Córdoba
-
Montería, Departamento de Córdoba, Colombia, 230002
- Werving
- IMAT S.A.S ( Site 2401)
-
Contact:
- Study Coordinator
- Telefoonnummer: +57 3135342052
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, Colombia, 760032
- Werving
- Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
-
Contact:
- Study Coordinator
- Telefoonnummer: +576023319090 - 4022
-
-
-
-
North Denmark
-
Aalborg, North Denmark, Denemarken, 9000
- Werving
- Aalborg Universitetshospital, Syd ( Site 0403)
-
Contact:
- Study Coordinator
- Telefoonnummer: +45 97660000
-
-
Region Sjælland
-
Koege, Region Sjælland, Denemarken, 4600
- Werving
- Sjællands Universitetshospital Køge ( Site 0402)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4556631500
-
-
Region Syddanmark
-
Odense C, Region Syddanmark, Denemarken, 5000
- Werving
- Odense Universitetshospital-Department of Hematology ( Site 0401)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4566613333
-
-
-
-
-
Berlin, Duitsland, 10707
- Werving
- Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4930887742570
-
-
Baden-Wurttemberg
-
Ulm, Baden-Wurttemberg, Duitsland, 89081
- Werving
- Universitaetsklinikum Ulm. ( Site 0601)
-
Contact:
- Study Coordinator
- Telefoonnummer: +497315000
-
-
Bavaria
-
Landshut, Bavaria, Duitsland, 84036
- Werving
- VK&K Studien GbR ( Site 0607)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4987197403429
-
-
North Rhine-Westphalia
-
Mönchengladbach, North Rhine-Westphalia, Duitsland, 41063
- Werving
- Kliniken Maria Hilf ( Site 0603)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4921618922201
-
-
Rhineland-Palatinate
-
Koblenz, Rhineland-Palatinate, Duitsland, 56068
- Werving
- InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4926192156930
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Duitsland, 06120
- Werving
- Universitätsklinikum Halle ( Site 0604)
-
Contact:
- Study Coordinator
- Telefoonnummer: +493455572054
-
-
-
-
-
Ioannina, Griekenland, 455 00
- Werving
- University Hospital of Ioannina ( Site 0702)
-
Contact:
- Study Coordinator
- Telefoonnummer: +302651099647
-
-
Attica
-
Athens, Attica, Griekenland, 106 76
- Werving
- Evangelismos General Hospital of Athens ( Site 0700)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0030 2132041721
-
Athens, Attica, Griekenland, 115 26
- Werving
- General Hospital of Athens "Laiko" ( Site 0704)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0030 2132061643
-
-
East Macedonia and Thrace
-
Alexandroupoli, East Macedonia and Thrace, Griekenland, 681 00
- Werving
- University Hospital of Alexandroupolis ( Site 0701)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0030 2551353739
-
-
-
-
-
Hong Kong, Hongkong
- Werving
- Queen Mary Hospital ( Site 3300)
-
Contact:
- Study Coordinator
- Telefoonnummer: +852 2255 3838
-
-
-
-
-
Haifa, Israël, 3109601
- Werving
- Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
-
Contact:
- Study Coordinator
- Telefoonnummer: 04-7771514
-
Haifa, Israël, 3339419
- Werving
- Bnai Zion Medical Center ( Site 1505)
-
Contact:
- Study Coordinator
- Telefoonnummer: 972506268114
-
Jerusalem, Israël, 9112001
- Werving
- Hadassah Medical Center-Hemato-Oncology ( Site 1500)
-
Contact:
- Study Coordinator
- Telefoonnummer: 972-56-9101736
-
Nahariya, Israël, 2201202
- Werving
- Galilee Medical Center ( Site 1507)
-
Contact:
- Study Coordinator
- Telefoonnummer: +97249107260
-
Petah Tikva, Israël, 4941492
- Werving
- Rabin Medical Center ( Site 1504)
-
Contact:
- Study Coordinator
- Telefoonnummer: 972-54-2200162
-
Ramat Gan, Israël, 5265601
- Werving
- Sheba Medical Center-Hemato Oncology ( Site 1501)
-
Contact:
- Study Coordinator
- Telefoonnummer: +972-35308401
-
Tsrifin, Israël, 7033001
- Werving
- Yitzhak Shamir Medical Center. ( Site 1506)
-
Contact:
- Study Coordinator
- Telefoonnummer: 972-8-9542443
-
-
-
-
-
Chiba, Japan, 260-8717
- Actief, niet wervend
- Chiba Cancer Center ( Site 1905)
-
Fukuoka, Japan, 812-8582
- Voltooid
- Kyushu University Hospital ( Site 1914)
-
Hiroshima, Japan, 730-8619
- Actief, niet wervend
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
-
Okayama, Japan, 700-8558
- Actief, niet wervend
- Okayama University Hospital ( Site 1912)
-
Osaka, Japan, 543-8555
- Actief, niet wervend
- Japanese Red Cross Osaka Hospital ( Site 1908)
-
Yamagata, Japan, 990-9585
- Actief, niet wervend
- Yamagata University Hospital ( Site 1902)
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Actief, niet wervend
- Nagoya University Hospital ( Site 1907)
-
-
Gunma
-
Maebashi, Gunma, Japan, 371-8511
- Actief, niet wervend
- Gunma University Hospital ( Site 1903)
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Actief, niet wervend
- Hokkaido University Hospital ( Site 1900)
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0047
- Actief, niet wervend
- Kobe City Medical Center General Hospital ( Site 1910)
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8574
- Actief, niet wervend
- Tohoku University Hospital ( Site 1901)
-
-
Osaka
-
Sakai, Osaka, Japan, 590-0197
- Actief, niet wervend
- Kindai University Hospital ( Site 1909)
-
-
Shimane
-
Izumo, Shimane, Japan, 693-8501
- Actief, niet wervend
- Shimane University Hospital ( Site 1911)
-
-
Tokyo
-
Koto, Tokyo, Japan, 135-8550
- Actief, niet wervend
- Cancer Institute Hospital of JFCR ( Site 1906)
-
-
-
-
Kuala Lumpur
-
Lembah Pantai, Kuala Lumpur, Maleisië, 59100
- Werving
- University Malaya Medical Centre ( Site 1604)
-
Contact:
- Study Coordinator
- Telefoonnummer: +60479492351
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Maleisië, 10450
- Werving
- Hospital Pulau Pinang ( Site 1602)
-
Contact:
- Study Coordinator
- Telefoonnummer: +6042225767
-
-
Sabah
-
Kota Kinabalu, Sabah, Maleisië, 88586
- Werving
- Queen Elizabeth Hospital ( Site 1603)
-
Contact:
- Study Coordinator
- Telefoonnummer: +6088517555
-
-
-
-
Mexico City
-
Benito Juárez, Mexico City, Mexico, 03100
- Werving
- Grupo Médico ASSET SC ( Site 2611)
-
Contact:
- Study Coordinator
- Telefoonnummer: +525516217417
-
Mexico City, Mexico City, Mexico, 03100
- Werving
- Centro de Infusion Superare ( Site 2602)
-
Contact:
- Study Coordinator
- Telefoonnummer: 5525020124
-
Mexico City, Mexico City, Mexico, 03100
- Voltooid
- Health Pharma Professional Research S.A. de C.V: ( Site 2608)
-
-
-
-
-
Auckland, Nieuw-Zeeland, 0622
- Werving
- North Shore Hospital-Department of Haematology ( Site 3200)
-
Contact:
- Study Coordinator
- Telefoonnummer: +64 9 486 8930
-
Auckland, Nieuw-Zeeland, 2025
- Werving
- Aotearoa Clinical Trials ( Site 3201)
-
Contact:
- Study Coordinator
- Telefoonnummer: (+64)0800272784
-
-
Waikato Region
-
Hamilton, Waikato Region, Nieuw-Zeeland, 3240
- Werving
- Waikato Hospital-Haematology ( Site 3202)
-
Contact:
- Study Coordinator
- Telefoonnummer: +64 7 839 8899
-
-
-
-
-
Oslo, Noorwegen, 0372
- Werving
- Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4791502770
-
-
Akershus
-
Lørenskog, Akershus, Noorwegen, 1474
- Werving
- Akershus Universitetssykehus ( Site 0902)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4767 96 00 00
-
-
Vestfold
-
Tønsberg, Vestfold, Noorwegen, 3103
- Werving
- Sykehuset i Vestfold ( Site 0903)
-
Contact:
- Study Coordinator
- Telefoonnummer: +4733342000
-
-
-
-
-
Lima, Peru, 15073
- Werving
- Clínica Anglo Americana ( Site 2701)
-
Contact:
- Study Coordinator
- Telefoonnummer: +5116168900
-
-
Ariqipa
-
Arequipa, Ariqipa, Peru, 054
- Werving
- Centro Medico Monte Carmelo-Oncology ( Site 2706)
-
Contact:
- Study Coordinator
- Telefoonnummer: +51980728089
-
-
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polen, 30-727
- Werving
- Pratia MCM Krakow ( Site 1007)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0048602338290
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Polen, 20-081
- Werving
- Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
-
Contact:
- Study Coordinator
- Telefoonnummer: +48 81 534 54 68
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Werving
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
-
Contact:
- Study Coordinator
- Telefoonnummer: +48225462223
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-214
- Werving
- Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
-
Contact:
- Study Coordinator
- Telefoonnummer: +48 58 584 43 57
-
Słupsk, Pomeranian Voivodeship, Polen, 76-200
- Voltooid
- Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, Polen, 44-102
- Werving
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
-
Contact:
- Study Coordinator
- Telefoonnummer: +48322788523
-
Katowice, Silesian Voivodeship, Polen, 40-519
- Werving
- Pratia Onkologia Katowice ( Site 1009)
-
Contact:
- Study Coordinator
- Telefoonnummer: +48501714019
-
-
Warmian-Masurian Voivodeship
-
Olsztyn, Warmian-Masurian Voivodeship, Polen, 10-228
- Werving
- Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
-
Contact:
- Study Coordinator
- Telefoonnummer: 48895398133
-
-
-
-
-
Lisbon, Portugal, 1449-005
- Werving
- Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
-
Contact:
- Study Coordinator
- Telefoonnummer: 00351210431703
-
Lisbon, Portugal, 1649-035
- Werving
- Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
-
Contact:
- Study Coordinator
- Telefoonnummer: +351217805000
-
Porto, Portugal, 4200-072
- Werving
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
-
Contact:
- Study Coordinator
- Telefoonnummer: 00351225084000
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal, 1099-023
- Werving
- Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
-
Contact:
- Study Coordinator
- Telefoonnummer: 00351217229800
-
Lisbon, Lisbon District, Portugal, 1400-038
- Werving
- Champalimaud Foundation ( Site 3102)
-
Contact:
- Study Coordinator
- Telefoonnummer: 00351210480200
-
-
Porto District
-
Vila Nova de Gaia, Porto District, Portugal, 4434-502
- Werving
- Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
-
Contact:
- Study Coordinator
- Telefoonnummer: 00351227865100
-
-
-
-
-
Barcelona, Spanje, 08035
- Werving
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
-
Contact:
- Study Coordinator
- Telefoonnummer: +34 934893806
-
Salamanca, Spanje, 37007
- Werving
- Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
-
Contact:
- Study Coordinator
- Telefoonnummer: 923291100 Ext. 55014
-
-
Barcelona
-
L'Hospitalet Del Llobregat, Barcelona, Spanje, 08908
- Werving
- Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
-
Contact:
- Study Coordinator
- Telefoonnummer: + 34 932607750
-
-
Catalonia
-
Barcelona, Catalonia, Spanje, 08036
- Werving
- HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
-
Contact:
- Study Coordinator
- Telefoonnummer: +34 619085109
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spanje, 28223
- Werving
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
-
Contact:
- Study Coordinator
- Telefoonnummer: +34 914521900
-
-
Madrid, Comunidad de
-
Majadahonda, Madrid, Comunidad de, Spanje, 28222
- Werving
- HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
-
Contact:
- Study Coordinator
- Telefoonnummer: +34 911917620
-
-
Santa Cruz De Tenerife
-
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spanje, 38320
- Werving
- hospital universitario de canarias ( Site 1205)
-
Contact:
- Study Coordinator
- Telefoonnummer: +34922678207
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Werving
- Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
-
Contact:
- Study Coordinator
- Telefoonnummer: +88677317123
-
Tainan, Taiwan, 704302
- Werving
- National Cheng Kung University Hospital ( Site 1700)
-
Contact:
- Study Coordinator
- Telefoonnummer: +88662752037
-
Taipei, Taiwan, 10048
- Werving
- National Taiwan University Hospital ( Site 1701)
-
Contact:
- Study Coordinator
- Telefoonnummer: +886972652039
-
Taoyuan, Taiwan, 33305
- Werving
- Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
-
Contact:
- Study Coordinator
- Telefoonnummer: +88633281200
-
-
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10700
- Werving
- Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
-
Contact:
- Study Coordinator
- Telefoonnummer: +6624197767
-
Pathumwan, Bangkok, Thailand, 10330
- Werving
- Chulalongkorn University ( Site 1802)
-
Contact:
- Study Coordinator
- Telefoonnummer: +6624197767
-
-
Changwat Phitsanulok
-
Muang, Changwat Phitsanulok, Thailand, 65000
- Werving
- Naresuan University Hospital ( Site 1804)
-
Contact:
- Study Coordinator
- Telefoonnummer: +6655965777
-
-
Changwat Songkhla
-
Hat Yai, Changwat Songkhla, Thailand, 90110
- Werving
- Songklanagarind hospital ( Site 1803)
-
Contact:
- Study Coordinator
- Telefoonnummer: 6674451735
-
-
Chiang Mai
-
Muang, Chiang Mai, Thailand, 50200
- Werving
- Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
-
Contact:
- Study Coordinator
- Telefoonnummer: 6653935488
-
-
-
-
-
Hradec Králové, Tsjechië, 500 05
- Werving
- Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
-
Contact:
- Study Coordinator
- Telefoonnummer: +420 777846836
-
Olomouc, Tsjechië, 779 00
- Werving
- Fakultni nemocnice Olomouc ( Site 0303)
-
Contact:
- Study Coordinator
- Telefoonnummer: +420588443940
-
Prague, Tsjechië, 128 08
- Werving
- Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
-
Contact:
- Study Coordinator
- Telefoonnummer: +420224962527
-
-
-
-
-
Ankara, Turkije (Türkiye), 06100
- Werving
- Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
-
Contact:
- Study Coordinator
- Telefoonnummer: +90312 310 33 33
-
Ankara, Turkije (Türkiye), 06800
- Werving
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
-
Contact:
- Study Coordinator
- Telefoonnummer: +90 312 552 60 00
-
Antalya, Turkije (Türkiye), 7100
- Werving
- Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
-
Contact:
- Study Coordinator
- Telefoonnummer: +90 242 2494400-4143
-
Edirne, Turkije (Türkiye), 22030
- Werving
- Trakya University Medical Faculty Hospital-Hematology ( Site 1403)
-
Contact:
- Study Coordinator
- Telefoonnummer: +905438561362
-
Istanbul, Turkije (Türkiye), 34214
- Werving
- Mega Medipol ( Site 1412)
-
Contact:
- Study Coordinator
- Telefoonnummer: +90 5077078197
-
Istanbul, Turkije (Türkiye), 34381
- Werving
- Sisli Florence Nightingale Hastanesi ( Site 1411)
-
Contact:
- Study Coordinator
- Telefoonnummer: +90444 04 36
-
Istanbul, Turkije (Türkiye), 34899
- Voltooid
- Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
-
Izmir, Turkije (Türkiye), 35100
- Werving
- Ege Universitesi Hastanesi ( Site 1404)
-
Contact:
- Study Coordinator
- Telefoonnummer: +905325566128
-
Samsun, Turkije (Türkiye), 55280
- Werving
- Ondokuz Mays Üniversitesi ( Site 1410)
-
Contact:
- Study Coordinator
- Telefoonnummer: +903624576041
-
-
-
-
-
Barnet, Verenigd Koninkrijk, EN5 3DJ
- Werving
- Barnet Hospital ( Site 3005)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0208 216 4755
-
Leeds, Verenigd Koninkrijk, LS9 7TF
- Werving
- St James's University Hospital ( Site 3004)
-
Contact:
- Study Coordinator
- Telefoonnummer: +441132432799
-
Nottingham, Verenigd Koninkrijk, NG5 1PB
- Voltooid
- City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
-
-
Bristol, City of
-
Bristol, Bristol, City of, Verenigd Koninkrijk, BS10 5NB
- Voltooid
- Southmead Hospital ( Site 3010)
-
-
Lancashire
-
Lancaster, Lancashire, Verenigd Koninkrijk, LA1 4RP
- Voltooid
- Royal Lancaster Infirmary ( Site 3012)
-
-
London, City of
-
London, London, City of, Verenigd Koninkrijk, EC1A 7BE
- Werving
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
-
Contact:
- Study Coordinator
- Telefoonnummer: +442073777000
-
-
Oxfordshire
-
Oxford, Oxfordshire, Verenigd Koninkrijk, OX3 7LE
- Werving
- The Churchill Hospital ( Site 3007)
-
Contact:
- Study Coordinator
- Telefoonnummer: 441865235886
-
-
South Gloucestershire
-
Bristol, South Gloucestershire, Verenigd Koninkrijk, BS32 4SY
- Werving
- GenesisCare - Bristol ( Site 3011)
-
Contact:
- Study Coordinator
- Telefoonnummer: +441173421121
-
-
Suffolk
-
Newmarket, Suffolk, Verenigd Koninkrijk, CB8 7XN
- Werving
- GenesisCare - Cambridge ( Site 3001)
-
Contact:
- Study Coordinator
- Telefoonnummer: 01223 907622
-
-
Windsor And Maidenhead
-
Windsor, Windsor And Maidenhead, Verenigd Koninkrijk, SL4 3HD
- Werving
- GenesisCare - Windsor ( Site 3002)
-
Contact:
- Study Coordinator
- Telefoonnummer: 447989474250
-
-
-
-
Alabama
-
Mobile, Alabama, Verenigde Staten, 36604
- Werving
- USA Mitchell Cancer Institute ( Site 0014)
-
Contact:
- Study Coordinator
- Telefoonnummer: 251-665-8000
-
-
Arizona
-
Gilbert, Arizona, Verenigde Staten, 85234
- Werving
- Banner MD Anderson Cancer Center ( Site 0059)
-
Contact:
- Study Coordinator
- Telefoonnummer: 480-256-5490
-
Phoenix, Arizona, Verenigde Staten, 85006
- Werving
- Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
-
Contact:
- Study Coordinator
- Telefoonnummer: 480-256-5490
-
Prescott, Arizona, Verenigde Staten, 86301
- Voltooid
- Arizona Oncology Associates - NAHOA ( Site 8007)
-
-
California
-
Berkeley, California, Verenigde Staten, 94704
- Actief, niet wervend
- Alta Bates Summit Medical Center ( Site 0004)
-
La Jolla, California, Verenigde Staten, 92093-0698
- Werving
- Moores Cancer Center ( Site 0003)
-
Contact:
- Study Coordinator
- Telefoonnummer: 858-534-5201
-
Pasadena, California, Verenigde Staten, 91105
- Werving
- Care Access - South Pasadena ( Site 0070)
-
Contact:
- Study Coordinator
- Telefoonnummer: 626-556-9930
-
-
Colorado
-
Denver, Colorado, Verenigde Staten, 80218
- Werving
- Saint Joseph Hospital ( Site 0026)
-
Contact:
- Study Coordinator
- Telefoonnummer: 303-403-6381
-
Golden, Colorado, Verenigde Staten, 80401
- Werving
- Lutheran Medical Center ( Site 0027)
-
Contact:
- Study Coordinator
- Telefoonnummer: 303-403-6381
-
Grand Junction, Colorado, Verenigde Staten, 81501
- Werving
- Intermountain Health St. Mary's Regional Hospital ( Site 0025)
-
Contact:
- Study Coordinator
- Telefoonnummer: 970-298-7638
-
-
Connecticut
-
Norwich, Connecticut, Verenigde Staten, 06360
- Werving
- Eastern CT Hematology & Oncology Associates ( Site 0033)
-
Contact:
- Study Coordinator
- Telefoonnummer: 860-886-8362
-
-
Florida
-
Boca Raton, Florida, Verenigde Staten, 33486
- Werving
- Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
-
Contact:
- Study Coordinator
- Telefoonnummer: 561-955-4800
-
Clermont, Florida, Verenigde Staten, 34711
- Werving
- Clermont Oncology Center ( Site 0046)
-
Contact:
- Study Coordinator
- Telefoonnummer: 386-538-3169
-
Fort Myers, Florida, Verenigde Staten, 33901
- Werving
- Florida Cancer Specialists - South ( Site 7001)
-
Contact:
- Study Coordinator
- Telefoonnummer: 239-274-9930
-
West Palm Beach, Florida, Verenigde Staten, 33401
- Werving
- Florida Cancer Specialists - East ( Site 7002)
-
Contact:
- Study Coordinator
- Telefoonnummer: 727-216-1143
-
-
Idaho
-
Boise, Idaho, Verenigde Staten, 83706
- Werving
- Saint Alphonsus Regional Medical Center ( Site 0067)
-
Contact:
- Study Coordinator
- Telefoonnummer: 208-367-3131
-
-
Indiana
-
Fort Wayne, Indiana, Verenigde Staten, 46845
- Werving
- Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
-
Contact:
- Study Coordinator
- Telefoonnummer: 260-266-7100
-
-
Iowa
-
Iowa City, Iowa, Verenigde Staten, 52242
- Werving
- University of Iowa Health Care. ( Site 0017)
-
Contact:
- Study Coordinator
- Telefoonnummer: 319-356-1616
-
Waukee, Iowa, Verenigde Staten, 50263
- Werving
- University of Iowa Health Care. ( Site 0057)
-
Contact:
- Study Coordinator
- Telefoonnummer: 319-356-1616
-
-
Kentucky
-
Edgewood, Kentucky, Verenigde Staten, 41017
- Werving
- Saint Elizabeth Healthcare ( Site 0041)
-
Contact:
- Study Coordinator
- Telefoonnummer: 859-301-2000
-
Owensboro, Kentucky, Verenigde Staten, 42303
- Werving
- Owensboro Medical Health System ( Site 0066)
-
Contact:
- Study Coordinator
- Telefoonnummer: 270-688-1938
-
-
Michigan
-
Grand Rapids, Michigan, Verenigde Staten, 49503
- Werving
- Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
-
Contact:
- Study Coordinator
- Telefoonnummer: 616-267-7566
-
-
Minnesota
-
Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Werving
- Regions Hospital ( Site 0042)
-
Contact:
- Study Coordinator
- Telefoonnummer: 952-993-3252
-
-
Missouri
-
Kansas City, Missouri, Verenigde Staten, 64132
- Werving
- MidAmerica Cancer Care, LLC ( Site 0043)
-
Contact:
- Study Coordinator
- Telefoonnummer: 816-974-5050
-
-
Montana
-
Billings, Montana, Verenigde Staten, 59102
- Werving
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
-
Contact:
- Study Coordinator
- Telefoonnummer: 406-238-6685
-
-
New Jersey
-
Florham Park, New Jersey, Verenigde Staten, 07932
- Voltooid
- Summit Medical Group Cancer Center ( Site 0007)
-
Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
-
Contact:
- Study Coordinator
- Telefoonnummer: 551-996-3277
-
-
New York
-
Albany, New York, Verenigde Staten, 12208
- Werving
- New York Oncology Hematology, P.C. ( Site 0069)
-
Contact:
- Study Coordinator
- Telefoonnummer: 518-262-6696
-
Buffalo, New York, Verenigde Staten, 14263
- Werving
- Roswell Park Cancer Institute ( Site 0023)
-
Contact:
- Study Coordinator
- Telefoonnummer: 716-845-2300
-
Williamsville, New York, Verenigde Staten, 14221
- Werving
- RPCI Oncology, PC- Northtowns ( Site 0061)
-
Contact:
- Study Coordinator
- Telefoonnummer: 716-634-3340
-
-
North Carolina
-
Charlotte, North Carolina, Verenigde Staten, 28207
- Werving
- Carolina Oncology Specialists, PA ( Site 0054)
-
Contact:
- Study Coordinator
- Telefoonnummer: 704-342-1900
-
Goldsboro, North Carolina, Verenigde Staten, 27534
- Werving
- Southeastern Medical Oncology Center ( Site 0049)
-
Contact:
- Study Coordinator
- Telefoonnummer: 919-587-9088
-
-
Pennsylvania
-
Broomall, Pennsylvania, Verenigde Staten, 19008
- Werving
- Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
-
Contact:
- Study Coordinator
- Telefoonnummer: 610-585-6287
-
York, Pennsylvania, Verenigde Staten, 17403
- Werving
- Cancer Care Associates Of York ( Site 0005)
-
Contact:
- Study Coordinator
- Telefoonnummer: 717-741-9229
-
-
Tennessee
-
Chattanooga, Tennessee, Verenigde Staten, 37404
- Werving
- Tennessee Oncology-Chattanooga ( Site 0045)
-
Contact:
- Study Coordinator
- Telefoonnummer: 615-986-4350
-
Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
-
Contact:
- Study Coordinator
- Telefoonnummer: 615-986-4350
-
-
Texas
-
Austin, Texas, Verenigde Staten, 78705
- Werving
- Texas Oncology - Central/South Texas ( Site 8008)
-
Contact:
- Study Coordinator
- Telefoonnummer: 512-421-4100
-
Fort Worth, Texas, Verenigde Staten, 76104
- Werving
- The Center for Cancer and Blood Disorders ( Site 0032)
-
Contact:
- Study Coordinator
- Telefoonnummer: 817-759-7013
-
San Antonio, Texas, Verenigde Staten, 78217
- Werving
- Texas Oncology - San Antonio ( Site 8006)
-
Contact:
- Study Coordinator
- Telefoonnummer: 210-419-2608
-
Tyler, Texas, Verenigde Staten, 75702
- Werving
- Texas Oncology - Northeast Texas ( Site 8012)
-
Contact:
- Study Coordinator
- Telefoonnummer: 903-579-9800
-
-
Virginia
-
Charlottesville, Virginia, Verenigde Staten, 22903
- Werving
- University of Virginia Cancer Center ( Site 0040)
-
Contact:
- Study Coordinator
- Telefoonnummer: 434-243-2649
-
Fairfax, Virginia, Verenigde Staten, 22031
- Werving
- Inova Schar Cancer Institute ( Site 0015)
-
Contact:
- Study Coordinator
- Telefoonnummer: 571-472-4724
-
Richmond, Virginia, Verenigde Staten, 23298
- Werving
- Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
-
Contact:
- Study Coordinator
- Telefoonnummer: 804-628-2072
-
-
Washington
-
Edmonds, Washington, Verenigde Staten, 98026
- Werving
- Swedish Cancer Institute, Edmonds Campus ( Site 0072)
-
Contact:
- Study Coordinator
- Telefoonnummer: 206-215-3100
-
Issaquah, Washington, Verenigde Staten, 98029
- Werving
- Swedish Cancer Institute, Issaquah Campus ( Site 0073)
-
Contact:
- Study Coordinator
- Telefoonnummer: 206-215-3100
-
Seattle, Washington, Verenigde Staten, 98104
- Werving
- Swedish Medical Center-Swedish Cancer Institute ( Site 0071)
-
Contact:
- Study Coordinator
- Telefoonnummer: 206-215-3100
-
Spokane, Washington, Verenigde Staten, 99208
- Werving
- Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
-
Contact:
- Study Coordinator
- Telefoonnummer: 509-462-2273
-
-
Wisconsin
-
Madison, Wisconsin, Verenigde Staten, 53792
- Werving
- University Hospital and UW Health Clinics ( Site 0006)
-
Contact:
- Study Coordinator
- Telefoonnummer: 608-263-6400
-
Madison, Wisconsin, Verenigde Staten, 53715
- Werving
- SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
-
Contact:
- Study Coordinator
- Telefoonnummer: 608-410-2700
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, Zuid-Afrika, 1864
- Werving
- Wits Clinical Research ( Site 1102)
-
Contact:
- Study Coordinator
- Telefoonnummer: +27119836501
-
Pretoria, Gauteng, Zuid-Afrika, 0181
- Werving
- Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
-
Contact:
- Study Coordinator
- Telefoonnummer: +27 12 993 2555
-
-
Western Cape
-
Cape Town, Western Cape, Zuid-Afrika, 7925
- Werving
- Groote Schuur Hospital-Clinical Haematology ( Site 1100)
-
Contact:
- Study Coordinator
- Telefoonnummer: +27727689024
-
Kuilsriver, Western Cape, Zuid-Afrika, 7580
- Werving
- Haemalife ( Site 1105)
-
Contact:
- Study Coordinator
- Telefoonnummer: +27219006277
-
Plumstead, Western Cape, Zuid-Afrika, 7800
- Werving
- Constantiaberg Haematology ( Site 1106)
-
Contact:
- Study Coordinator
- Telefoonnummer: 0217992558
-
-
-
-
Stockholm County
-
Stockholm, Stockholm County, Zweden, 171 64
- Werving
- Karolinska Universitetssjukhuset Solna ( Site 1302)
-
Contact:
- Study Coordinator
- Telefoonnummer: +46812370000
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Nemtabrutinib
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
Administered orally
Andere namen:
|
|
Actieve vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata
- Chronische ziekte
- Ziekte attributen
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Leukemie, B-cel
- Leukemie, Lymfoïde
- Leukemie
- Pathologische aandoeningen, tekenen en symptomen
- Hemische en lymfatische ziekten
- Leukemie, lymfatische, chronische, B-cel
- acalabrutinib
- Ibrutinib
- ARQ531
Andere studie-ID-nummers
- 1026-011
- U1111-1281-7895 (Register-ID: UTN)
- MK-1026-011 (Andere identificatie: MSD)
- BELLWAVE-011 (Andere identificatie: MSD)
- jRCT2031230697 (Register-ID: jRCT)
- 2022-501697-19-00 (Register-ID: EU CT)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .