Um estudo para investigar a sobrevida livre de progressão com Sonrotoclax mais Obinutuzumab ou Sonrotoclax mais rituximab em comparação com o tratamento com venetoclax mais rituximabe em pacientes com leucemia linfocitária crônica e/ou refratária (leucemia linstial-rônica)/linfomoma linstial-rônica) (Celestial-RLL))
21 de outubro de 2026 atualizado por: BeOne Medicines
Um estudo randomizado e multicêntrico, randomizado da fase 3, de terapias anticorpos Sonrotoclax mais anticorpos anti-CD20 versus venetoclax mais rituximabe em pacientes com leucemia linfocítica crônica recidivada/refratária/linfoma linfocítico pequeno/refratário
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Tipo de estudo
Intervencional
Inscrição (Estimado)
630
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Study Director
- Número de telefone: 1-877-828-5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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Berlin, Alemanha, 10707
- Recrutamento
- Osp Kurfuerstendamm
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Cologne, Alemanha, 50937
- Recrutamento
- Uniklinik Koeln (Aoer)
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Dresden, Alemanha, 01307
- Recrutamento
- Gokos Gmbh
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Jena, Alemanha, 07747
- Recrutamento
- Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
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Kiel, Alemanha, 24105
- Recrutamento
- Universitatsklinikum Schleswig Holstein Campus Kiel
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Mutlangen, Alemanha, 73557
- Recrutamento
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Alemanha, 81377
- Recrutamento
- Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
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Neubrandenburg, Alemanha, 17036
- Recrutamento
- Dietrich Bonhoeffer Klinikum Neubrandenburg
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Tübingen, Alemanha, 72076
- Recrutamento
- Medizinische Universitaetsklinik
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Ulm, Alemanha, 89081
- Recrutamento
- Universitaetsklinikum Ulm
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Würzburg, Alemanha, 97080
- Recrutamento
- Haematologisch Onkologische Schwerpunktpraxis
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Caba, Argentina, CP1114
- Recrutamento
- FUNDALEU
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Caba, Argentina, 1425
- Recrutamento
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1426
- Recrutamento
- Instituto Alexander Fleming (Iaf)
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New South Wales
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Blacktown, New South Wales, Austrália, NSW 2148
- Recrutamento
- Blacktown Cancer and Haematology Centre
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Kogarah, New South Wales, Austrália, NSW 2217
- Recrutamento
- St George Hospital
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Lismore, New South Wales, Austrália, NSW 2480
- Recrutamento
- Northern Nsw Health District
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North Ryde, New South Wales, Austrália, NSW 2109
- Recrutamento
- Macquarie University
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St Leonards, New South Wales, Austrália, NSW 2065
- Recrutamento
- Genesiscare North Shore
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Queensland
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Birtinya, Queensland, Austrália, QLD 4575
- Recrutamento
- Sunshine Coast Hospital and Health Service
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Woolloongabba, Queensland, Austrália, QLD 4102
- Recrutamento
- Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Austrália, VIC 3168
- Recrutamento
- Monash Health
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Fitzroy, Victoria, Austrália, VIC 3065
- Recrutamento
- St Vincents Hospital Melbourne
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Melbourne, Victoria, Austrália, VIC 3004
- Recrutamento
- The Alfred Hospital
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Melbourne, Victoria, Austrália, VIC 3000
- Recrutamento
- Peter Maccallum Cancer Centre
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Western Australia
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Cooloongup, Western Australia, Austrália, WA 6168
- Recrutamento
- Rockingham Hospital
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West Perth, Western Australia, Austrália, WA 6005
- Recrutamento
- Perth Blood Institute
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Belo Horizonte, Brasil, 30110-022
- Ativo, não recrutando
- CETUS
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Campinas, Brasil, 13083-878
- Ativo, não recrutando
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Curitiba, Brasil, 81520-060
- Ativo, não recrutando
- Hospital Erasto Gaertner
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Niterói, Brasil, 24020-096
- Ativo, não recrutando
- Complexo Hospitalar de Niteroi
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Porto Alegre, Brasil, 90020-090
- Ativo, não recrutando
- Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
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Rio de Janeiro, Brasil, 22281-100
- Ativo, não recrutando
- Instituto Dor de Pesquisa E Ensino Rio de Janeiro
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Rio de Janeiro, Brasil, 22061-080
- Ativo, não recrutando
- Hospital Sao Lucas
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Salvador, Brasil, 40050-410
- Ativo, não recrutando
- Hospital Santa Izabel
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São Paulo, Brasil, 04014-002
- Ativo, não recrutando
- Instituto Brasileiro de Controle Do Cancer
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São Paulo, Brasil, 01409-001
- Ativo, não recrutando
- Hospital Nove de Julho Dasa
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São Paulo, Brasil, 01232-010
- Ativo, não recrutando
- Hospital Samaritano Sao Paulo
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São Paulo, Brasil, 01401-004
- Ativo, não recrutando
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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São Paulo, Brasil, 05403-010
- Ativo, não recrutando
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasil, 29043-260
- Ativo, não recrutando
- Hospital Santa Rita de Cassia Afecc
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Brussels, Bélgica, 1200
- Recrutamento
- Cliniques Universitaires Saint Luc
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Edegem, Bélgica, 2650
- Recrutamento
- Uz Antwerpen
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Leuven, Bélgica, 3000
- Recrutamento
- University Hospitals Leuven
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Québec, Canadá, G1J 1Z4
- Recrutamento
- Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Recrutamento
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Recrutamento
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- Recrutamento
- British Columbia Cancer Agency the Vancouver Centre
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- Recrutamento
- Cancercare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Recrutamento
- Newfoundland and Labrador Health Services
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Recrutamento
- The Ottawa Hospital
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Toronto, Ontario, Canadá, M5G 2M9
- Recrutamento
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canadá, H4J 1C5
- Recrutamento
- Ciusss Nim Hscm
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Recrutamento
- China Japan Friendship Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 630014
- Recrutamento
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, China, 350001
- Recrutamento
- Fujian Provincial Hospital
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Fuzhou, Fujian, China, 350005
- Recrutamento
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, Fujian, China, 350108
- Recrutamento
- Fujian Medical University Union Hospitalqishan Branch
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Xiamen, Fujian, China, 361003
- Recrutamento
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Recrutamento
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, China, 510013
- Recrutamento
- Guangzhou First Peoples Hospital
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Guangzhou, Guangdong, China, 510000
- Recrutamento
- Zhujiang Hospital of Southern Medical University
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Guangxi
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Nanning, Guangxi, China, 530201
- Recrutamento
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hebei
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Shijiazhuang, Hebei, China, 050000
- Recrutamento
- The Second Hospital of Hebei Medical University
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recrutamento
- Harbin Medical University Cancer Hospital
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Henan
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Xinxiang, Henan, China, 453100
- Recrutamento
- The First Affiliated Hospital of Xinxiang Medical University
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Hubei
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Shiyan, Hubei, China, 442000
- Recrutamento
- Taihe Hospital
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Wuhan, Hubei, China, 430030
- Recrutamento
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, China, 410008
- Recrutamento
- Xiangya Hospital of Central South University
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Inner Mongolia
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Hohhot, Inner Mongolia, China, 010050
- Recrutamento
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Recrutamento
- Zhongda Hospital Southeast University
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Suzhou, Jiangsu, China, 215001
- Recrutamento
- Suzhou Municipal Hospitalbaita Branch
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Wuxi, Jiangsu, China, 214122
- Recrutamento
- Affiliated Hospital of Jiangnan University South Campus
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Yangzhou, Jiangsu, China, 225001
- Recrutamento
- Northern Jiangsu Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330029
- Recrutamento
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, China, 110001
- Recrutamento
- The First Hospital of China Medical University
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Shenyang, Liaoning, China, 110042
- Recrutamento
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, China, 710068
- Recrutamento
- Shaanxi Provincial Peoples Hospital
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Shandong
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Jinan, Shandong, China, 250000
- Recrutamento
- Shandong Provincial Hospital
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Jining, Shandong, China, 272000
- Recrutamento
- Jining No1 Peoples Hospital West Branch
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Qingdao, Shandong, China, 266555
- Recrutamento
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Recrutamento
- Affiliated Zhongshan Hospital of Fudan University
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Shanghai, Shanghai Municipality, China, 200000
- Recrutamento
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, China, 610041
- Recrutamento
- West China Hospital, Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 301617
- Recrutamento
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recrutamento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
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Ningbo, Zhejiang, China, 315040
- Recrutamento
- The Affiliated Peoples Hospital of Ningbo University
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Taizhou, Zhejiang, China, 317004
- Recrutamento
- Taizhou Hospital of Zhejiang Province (East)
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Busan Gwang'yeogsi
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Seogu, Busan Gwang'yeogsi, Coréia do Sul, 49241
- Recrutamento
- Pusan National University Hospital
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Gyeonggi-do
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IlsandongGu GoyangSi, Gyeonggi-do, Coréia do Sul, 10408
- Recrutamento
- National Cancer Center (Korea)
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Seongnam-si, Gyeonggi-do, Coréia do Sul, 13620
- Recrutamento
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Coréia do Sul, 06351
- Recrutamento
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Coréia do Sul, 06591
- Recrutamento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Coréia do Sul, 03722
- Recrutamento
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Coréia do Sul, 03080
- Recrutamento
- Seoul National University Hospital
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Aalborg, Dinamarca, 9000
- Recrutamento
- University Hospital of Aalborg
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Copenhagen, Dinamarca, 2100
- Recrutamento
- Rigshospitalet
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Køge, Dinamarca, 4600
- Recrutamento
- Zealand University Hospital
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Odense, Dinamarca, 5000
- Recrutamento
- Odense University Hospital
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Barcelona, Espanha, 08036
- Recrutamento
- Hospital Clinic de Barcelona
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Barcelona, Espanha, 08035
- Recrutamento
- Vall D Hebron Institute of Oncology Vhio
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LHospitalet de Llobregat, Espanha, 08908
- Recrutamento
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, Espanha, 28031
- Recrutamento
- Hospital Universitario Infanta Leonor
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Madrid, Espanha, 28006
- Recrutamento
- Hospital de La Princesa
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Marbella, Espanha, 29603
- Recrutamento
- Costa Del Sol (Marbella, Malaga)
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Salamanca, Espanha, 37007
- Recrutamento
- Hospital Universitario de Salamanca
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Santander, Espanha, 39008
- Recrutamento
- Hospital Universitario Marques de Valdecilla
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Seville, Espanha, 41014
- Recrutamento
- Hospital Virgen de Valme (Sevilla)
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California
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Laguna Hills, California, Estados Unidos, 92653
- Recrutamento
- Uci Health Laguna Hills
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Orange, California, Estados Unidos, 92868-3201
- Recrutamento
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Estados Unidos, 94304-2205
- Recrutamento
- Stanford Cancer Institute
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San Diego, California, Estados Unidos, 92103-2106
- Recrutamento
- Scripps Prebys Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80012-5405
- Recrutamento
- Rocky Mountain Cancer Centers (Williams) Usor
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Recrutamento
- Yale University Yale Cancer Center
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Norwich, Connecticut, Estados Unidos, 06360-2700
- Recrutamento
- Eastern Connecticut Hematology and Oncology
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Florida
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Weston, Florida, Estados Unidos, 33331-3609
- Recrutamento
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Northwestern University
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Niles, Illinois, Estados Unidos, 60714-5905
- Recrutamento
- Illinois Cancer Specialists (Niles) Usor
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Recrutamento
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Estados Unidos, 50263
- Recrutamento
- Mission Cancer and Blood
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Recrutamento
- University of Louisville, Brown Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809-3738
- Recrutamento
- Mary Bird Perkins Cancer Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Recrutamento
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215-5418
- Recrutamento
- Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02215-5400
- Recrutamento
- Beth Israel Deaconess Medical Center (Bidmc)
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503-2563
- Recrutamento
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905-0001
- Recrutamento
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198
- Recrutamento
- University of Nebraska Medical Center
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New Jersey
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Sewell, New Jersey, Estados Unidos, 08080
- Recrutamento
- Sidney Kimmel Comprehensive Cancer Center Washington Twp
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New Mexico
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Santa Fe, New Mexico, Estados Unidos, 87505
- Recrutamento
- Christus St Vincent Regional Cancer Center
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New York
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New York, New York, Estados Unidos, 10065-6800
- Recrutamento
- Memorial Sloan Kettering Cancer Center Mskcc
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Westbury, New York, Estados Unidos, 11590-5119
- Recrutamento
- Optum Medical Care, Pc
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514-4220
- Recrutamento
- University of North Carolina At Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28204-2990
- Recrutamento
- Levine Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Recrutamento
- Atrium Health Wake Forest Baptist
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45245-1995
- Recrutamento
- Oncology Hematology Care Clinical Trials, Llc
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Recrutamento
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Recrutamento
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107-4216
- Recrutamento
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Estados Unidos, 15232-1309
- Recrutamento
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Recrutamento
- Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
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Nashville, Tennessee, Estados Unidos, 37205
- Recrutamento
- Tennessee Oncology
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Texas
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Dallas, Texas, Estados Unidos, 75246-2003
- Recrutamento
- Texas Oncology Baylor Charles A Sammons Cancer Center
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San Antonio, Texas, Estados Unidos, 78240-5251
- Recrutamento
- Texas Oncology San Antonio Medical Center Usor
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Tyler, Texas, Estados Unidos, 75702-7522
- Recrutamento
- Texas Oncology Tyler
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Recrutamento
- Swedish Medical Center Swedish Cancer Institute First Hill Campus
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Vancouver, Washington, Estados Unidos, 98684-6930
- Recrutamento
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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ClermontFerrand, França, 63100
- Recrutamento
- Chu Clermont Ferrand Therapie Cellulaire and Hematolo
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Nantes, França, 44000
- Recrutamento
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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Paris, França, 75013
- Recrutamento
- Hopital de La Pitie Salpetriere
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PierreBenite, França, 69495
- Recrutamento
- Chu Hopital Lyon Sud
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Reims, França, 51100
- Recrutamento
- Hopital Robert Debre
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Rennes Cedes, França, 35000
- Recrutamento
- Chu Rennes
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Rouen, França, 76038
- Recrutamento
- Centre Henri Becquerel
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Toulouse, França, 31100
- Recrutamento
- Iuct Oncopole
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VandoeuvrelesNancy, França, 54511
- Recrutamento
- Chu Nancy Hopital Brabois
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Almere Stad, Holanda, 1315 RA
- Recrutamento
- Flevoziekenhuis
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Arnhem, Holanda, 6815 AD
- Recrutamento
- Rijnstate
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Dordrecht, Holanda, 3318 AT
- Recrutamento
- Albert Schweitzer Ziekenhuis
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Hilversum, Holanda, 1212 VG
- Recrutamento
- Tergooi Mc
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Dublin, Irlanda, D7
- Recrutamento
- Mater Misericordiae University Hospital
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Dublin, Irlanda, D08 NHY1
- Recrutamento
- St Jamess Hospital
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Galway, Irlanda, H91 YR71
- Recrutamento
- University Hospital Galway
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Limerick, Irlanda, V94F858
- Recrutamento
- University Hospital Limerick
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Bari, Itália, 70124
- Recrutamento
- Azienda Ospedaliera Policlinico Di Bari
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Cagliari, Itália, 09121
- Recrutamento
- Ao Brotzu Ospedale Oncologico Armando Businco
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Catania, Itália, 95123
- Recrutamento
- Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
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Ferrara, Itália, 44124
- Recrutamento
- Azienda Ospedaliero Universitaria Di Ferrara
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Milan, Itália, 20132
- Recrutamento
- Ospedale San Raffaele
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Milan, Itália, 20162
- Recrutamento
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Modena, Itália, 41124
- Recrutamento
- Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
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Pagani, Itália, 84014
- Recrutamento
- Asl Salerno Andrea Tortora
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Auckland, Nova Zelândia, 1023
- Recrutamento
- Auckland City Hospital
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Auckland, Nova Zelândia, 0622
- Recrutamento
- North Shore Hospital
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Lodz, Polônia, 93-510
- Recrutamento
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Torun, Polônia, 87-100
- Recrutamento
- Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
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Wroclaw, Polônia, 50-367
- Recrutamento
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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Bournemouth, Reino Unido, BH7 7DW
- Recrutamento
- University Hospitals Dorset Royal Bournemouth Hospital
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Headington, Reino Unido, OX3 7LE
- Recrutamento
- Oxford University Hospitals Nhs Trust Churchill Hospital
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Leeds, Reino Unido, LS9 7TF
- Recrutamento
- St Jamess University Hospital
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London, Reino Unido, SE5 9RS
- Recrutamento
- Kings College Hospital
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Metropolitan Borough of Wirral, Reino Unido, CH63 4JY
- Recrutamento
- Clatterbridge Cancer Centre
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Recrutamento
- Freeman Hospital
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Truro, Reino Unido, TR1 3LJ
- Recrutamento
- Royal Cornwall Hospitalsnhs Trust
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Gothenburg, Suécia, 413 46
- Recrutamento
- Sahlgrenska University Hospital Hematology
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Lund, Suécia, 221 85
- Recrutamento
- Skanes Universitetssjukhus I Lund
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Stockholm, Suécia, 171 76
- Recrutamento
- Karolinska Universitetssjukhuset Solna
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Uppsala, Suécia, 751 85
- Recrutamento
- Uppsala Akademiska Sjukhus
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Brno, Tcheca, 625 00
- Recrutamento
- Fakultni Nemocnice Brno
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Hradec Králové, Tcheca, 500 03
- Recrutamento
- Fakultni Nemocnice Hradec Kralove
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Prague, Tcheca, 128 00
- Recrutamento
- Ustav Hematologie A Krevni Transfuze (Uhkt)
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Prague, Tcheca, 10000
- Recrutamento
- Vseobecna Fakultni Nemocnice V Praze
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Innsbruck, Áustria, 6020
- Recrutamento
- Medizinische Universitatsklinik Innsbruck
-
Vienna, Áustria, 1140
- Recrutamento
- Hanusch Krankenhaus
-
Vienna, Áustria, 1090
- Recrutamento
- Medical University Vienna Oncology
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
- Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Adequate organ function
Exclusion Criteria:
- Known active prolymphocytic leukemia or currently suspected Richter's transformation
- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
- Known central nervous system involvement by CLL/SLL
- Severe or debilitating pulmonary disease
- Clinically significant cardiovascular disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination. |
Administered orally
Outros nomes:
Administered intravenously
Outros nomes:
|
|
Experimental: Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination. |
Administered orally
Outros nomes:
Administered intravenously
Outros nomes:
|
|
Experimental: Arm C: Sonrotoclax plus Obinutuzumab (MRD)
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD). |
Administered orally
Outros nomes:
Administered intravenously
Outros nomes:
|
|
Comparador Ativo: Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination. |
Administered intravenously
Outros nomes:
Administered Orally
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Prazo: Up to approximately 51 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 51 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
Prazo: Up to approximately 69 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 69 months
|
|
Rate of uMRD4 for Arm A versus Arm D
Prazo: Up to approximately 12 months
|
The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS) |
Up to approximately 12 months
|
|
Complete Response Rate as assessed by BIRC for Arm A versus Arm D
Prazo: Up to approximately 25 months
|
Complete Response Rate (CRR) is defined as the percentage of participants that achieve a best response of complete response (CR) or complete response with incomplete hematopoietic recovery (CRi) |
Up to approximately 25 months
|
|
Overall Survival for Arm A versus Arm D
Prazo: Up to approximately 84 months
|
Overall survival (OS) is defined as the time from the date of randomization to the date of death |
Up to approximately 84 months
|
|
PFS per Investigator Assessment (INV) for Arm B versus Arm D
Prazo: Up to approximately 69 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 69 months
|
|
CRR per BIRC and by INV for Arm B versus Arm D
Prazo: Up to approximately 25 months
|
CRR is defined as the percentage of participants that achieve a best response of CR or CRi |
Up to approximately 25 months
|
|
OS for Arm B versus Arm D
Prazo: Up to approximately 84 months
|
OS is defined as the time from the date of randomization to the date of death |
Up to approximately 84 months
|
|
Rate of uMRD4 for Arm B versus Arm D
Prazo: Up to approximately 25 months
|
The rate of uMRD4 in peripheral blood based on NGS |
Up to approximately 25 months
|
|
PFS per BIRC and by INV for Arm A versus Arm B
Prazo: Up to approximately 69 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 69 months
|
|
CRR per BIRC and by INV for Arm A versus Arm B
Prazo: Up to approximately 25 months
|
CRR is defined as the percentage of participants that achieve a best response of CR or CRi |
Up to approximately 25 months
|
|
OS for Arm A versus Arm B
Prazo: Up to approximately 84 months
|
OS is defined as the time from the date of randomization to the date of death |
Up to approximately 84 months
|
|
Rate of uMRD4 for Arm A versus Arm B
Prazo: Up to approximately 25 months
|
The rate of uMRD4 in peripheral blood based on NGS |
Up to approximately 25 months
|
|
Rate of uMRD4 for Arm A versus Arm D
Prazo: Up to approximately 25 months
|
The rate of uMRD4 in peripheral blood based on NGS |
Up to approximately 25 months
|
|
CRR per INV for Arm A versus Arm D
Prazo: Up to approximately 25 months
|
CRR is defined as the percentage of participants that achieve a best response of CR or CRi |
Up to approximately 25 months
|
|
PFS per INV for Arm A versus Arm D
Prazo: Up to approximately 51 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 51 months
|
|
PFS per INV for Arm C versus Arm D
Prazo: Up to approximately 69 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Up to approximately 69 months
|
|
CRR per INV for Arm C versus Arm D
Prazo: Up to approximately 25 months
|
CRR is defined as the percentage of participants that achieve a best response of CR or CRi |
Up to approximately 25 months
|
|
OS for Arm C versus Arm D
Prazo: Up to approximately 84 months
|
OS is defined as the time from the date of randomization to the date of death |
Up to approximately 84 months
|
|
Rate of uMRD4 for Arm C versus Arm D
Prazo: Up to approximately 25 months
|
The rate of uMRD4 in peripheral blood based on NGS |
Up to approximately 25 months
|
|
Overall Response Rate (ORR) per BIRC and by INV
Prazo: Up to approximately 25 months
|
ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better |
Up to approximately 25 months
|
|
Duration of Response (DOR) per BIRC and by INV
Prazo: Up to approximately 69 months
|
DOR is defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurs first |
Up to approximately 69 months
|
|
Time to Response (TTR) per BIRC and by INV
Prazo: Up to approximately 25 months
|
TTR is defined as the time from the date of randomization to the date response criteria were first met |
Up to approximately 25 months
|
|
Time to Next Anti-CLL/SLL Treatment (TTNT)
Prazo: Up to approximately 84 months
|
TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment |
Up to approximately 84 months
|
|
Rate of uMRD4
Prazo: Up to approximately 25 months
|
The rate of uMRD4 in peripheral blood based on NGS |
Up to approximately 25 months
|
|
Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales
Prazo: Baseline and up to approximately 69 months
|
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in global health status (GHS) and functional scales indicate better health-related quality of life (HRQoL). |
Baseline and up to approximately 69 months
|
|
Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales
Prazo: Baseline and up to approximately 69 months
|
The EORTC QLQ-CLL17 is the CLL module of QLQ-C30 consisting of 17 items and comprising 3 scales: symptom burden due to disease and/or treatment (6 items), physical condition/fatigue (4 items), and worries/fears about health and functioning (7 items) Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. Lower scores indicate better HRQoL. |
Baseline and up to approximately 69 months
|
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Prazo: From the first dose of study drug(s) to 30 days after the last dose of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months
|
Number of participants with TEAEs, including laboratory values, vital signs, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. |
From the first dose of study drug(s) to 30 days after the last dose of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de junho de 2025
Conclusão Primária (Estimado)
30 de setembro de 2029
Conclusão do estudo (Estimado)
1 de dezembro de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
17 de abril de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de abril de 2025
Primeira postagem (Real)
24 de abril de 2025
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de outubro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de outubro de 2026
Última verificação
1 de março de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias
- Doença crônica
- Atributos da doença
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Leucemia de Células B
- Leucemia Linfóide
- Leucemia
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Leucemia Linfocítica Crônica de Células B
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Anticorpos, monoclonais, derivados de murinos
- Rituximabe
- Venetoclax
- Obinutuzumab
Outros números de identificação do estudo
- BGB-11417-303
- 2024-517131-52-00 (Ctis)
- CLL-RR1 (Outro identificador: German CLL Study Group)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Prazo de Compartilhamento de IPD
See plan description
Critérios de acesso de compartilhamento IPD
See plan description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .