Uno studio per studiare la sopravvivenza libera da progressione con sonrotoclax più obinutuzumab o sonrotoclax più rituximab rispetto al trattamento con rituximab venetoclax più in pazienti con leucemia linfocitica cronica recidivata e refrattaria)
21 ottobre 2026 aggiornato da: BeOne Medicines
Uno studio multiplo randomizzato di fase 3, in aperto e multicentrico di Sonrotoclax più terapie anticorpi anti-CD20 rispetto a venetoclax più rituximab in pazienti con leucemia linfocitica cronica recidivata/refrattaria
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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
630
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Study Director
- Numero di telefono: 1-877-828-5568
- Email: clinicaltrials@beonemed.com
Luoghi di studio
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Caba, Argentina, CP1114
- Reclutamento
- FUNDALEU
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Caba, Argentina, 1425
- Reclutamento
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1426
- Reclutamento
- Instituto Alexander Fleming (Iaf)
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Reclutamento
- Blacktown Cancer and Haematology Centre
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Kogarah, New South Wales, Australia, NSW 2217
- Reclutamento
- St George Hospital
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Lismore, New South Wales, Australia, NSW 2480
- Reclutamento
- Northern Nsw Health District
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North Ryde, New South Wales, Australia, NSW 2109
- Reclutamento
- Macquarie University
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St Leonards, New South Wales, Australia, NSW 2065
- Reclutamento
- Genesiscare North Shore
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Queensland
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Birtinya, Queensland, Australia, QLD 4575
- Reclutamento
- Sunshine Coast Hospital and Health Service
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Woolloongabba, Queensland, Australia, QLD 4102
- Reclutamento
- Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Australia, VIC 3168
- Reclutamento
- Monash Health
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Fitzroy, Victoria, Australia, VIC 3065
- Reclutamento
- St Vincents Hospital Melbourne
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Melbourne, Victoria, Australia, VIC 3004
- Reclutamento
- The Alfred Hospital
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Melbourne, Victoria, Australia, VIC 3000
- Reclutamento
- Peter Maccallum Cancer Centre
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Western Australia
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Cooloongup, Western Australia, Australia, WA 6168
- Reclutamento
- Rockingham Hospital
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West Perth, Western Australia, Australia, WA 6005
- Reclutamento
- Perth Blood Institute
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Innsbruck, Austria, 6020
- Reclutamento
- Medizinische Universitatsklinik Innsbruck
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Vienna, Austria, 1140
- Reclutamento
- Hanusch Krankenhaus
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Vienna, Austria, 1090
- Reclutamento
- Medical University Vienna Oncology
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Brussels, Belgio, 1200
- Reclutamento
- Cliniques Universitaires Saint Luc
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Edegem, Belgio, 2650
- Reclutamento
- Uz Antwerpen
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Leuven, Belgio, 3000
- Reclutamento
- University Hospitals Leuven
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Belo Horizonte, Brasile, 30110-022
- Attivo, non reclutante
- CETUS
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Campinas, Brasile, 13083-878
- Attivo, non reclutante
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Curitiba, Brasile, 81520-060
- Attivo, non reclutante
- Hospital Erasto Gaertner
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Niterói, Brasile, 24020-096
- Attivo, non reclutante
- Complexo Hospitalar de Niteroi
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Porto Alegre, Brasile, 90020-090
- Attivo, non reclutante
- Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
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Rio de Janeiro, Brasile, 22281-100
- Attivo, non reclutante
- Instituto Dor de Pesquisa E Ensino Rio de Janeiro
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Rio de Janeiro, Brasile, 22061-080
- Attivo, non reclutante
- Hospital Sao Lucas
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Salvador, Brasile, 40050-410
- Attivo, non reclutante
- Hospital Santa Izabel
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São Paulo, Brasile, 04014-002
- Attivo, non reclutante
- Instituto Brasileiro de Controle Do Cancer
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São Paulo, Brasile, 01409-001
- Attivo, non reclutante
- Hospital Nove de Julho Dasa
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São Paulo, Brasile, 01232-010
- Attivo, non reclutante
- Hospital Samaritano Sao Paulo
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São Paulo, Brasile, 01401-004
- Attivo, non reclutante
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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São Paulo, Brasile, 05403-010
- Attivo, non reclutante
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasile, 29043-260
- Attivo, non reclutante
- Hospital Santa Rita de Cassia Afecc
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Québec, Canada, G1J 1Z4
- Reclutamento
- 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, Canada, T2N 5G2
- Reclutamento
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Reclutamento
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- Reclutamento
- British Columbia Cancer Agency the Vancouver Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Reclutamento
- Cancercare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Reclutamento
- Newfoundland and Labrador Health Services
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Reclutamento
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Reclutamento
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- Reclutamento
- Ciusss Nim Hscm
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Brno, Cechia, 625 00
- Reclutamento
- Fakultni Nemocnice Brno
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Hradec Králové, Cechia, 500 03
- Reclutamento
- Fakultni Nemocnice Hradec Kralove
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Prague, Cechia, 128 00
- Reclutamento
- Ustav Hematologie A Krevni Transfuze (Uhkt)
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Prague, Cechia, 10000
- Reclutamento
- Vseobecna Fakultni Nemocnice V Praze
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100029
- Reclutamento
- China Japan Friendship Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Cina, 630014
- Reclutamento
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Cina, 350001
- Reclutamento
- Fujian Provincial Hospital
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Fuzhou, Fujian, Cina, 350005
- Reclutamento
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, Fujian, Cina, 350108
- Reclutamento
- Fujian Medical University Union Hospitalqishan Branch
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Xiamen, Fujian, Cina, 361003
- Reclutamento
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Cina, 510515
- Reclutamento
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, Cina, 510013
- Reclutamento
- Guangzhou First Peoples Hospital
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Guangzhou, Guangdong, Cina, 510000
- Reclutamento
- Zhujiang Hospital of Southern Medical University
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Guangxi
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Nanning, Guangxi, Cina, 530201
- Reclutamento
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hebei
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Shijiazhuang, Hebei, Cina, 050000
- Reclutamento
- The Second Hospital of Hebei Medical University
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Heilongjiang
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Harbin, Heilongjiang, Cina, 150000
- Reclutamento
- Harbin Medical University Cancer Hospital
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Henan
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Xinxiang, Henan, Cina, 453100
- Reclutamento
- The First Affiliated Hospital of Xinxiang Medical University
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Hubei
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Shiyan, Hubei, Cina, 442000
- Reclutamento
- Taihe Hospital
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Wuhan, Hubei, Cina, 430030
- Reclutamento
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Cina, 410008
- Reclutamento
- Xiangya Hospital of Central South University
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Inner Mongolia
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Hohhot, Inner Mongolia, Cina, 010050
- Reclutamento
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangsu
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Nanjing, Jiangsu, Cina, 210009
- Reclutamento
- Zhongda Hospital Southeast University
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Suzhou, Jiangsu, Cina, 215001
- Reclutamento
- Suzhou Municipal Hospitalbaita Branch
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Wuxi, Jiangsu, Cina, 214122
- Reclutamento
- Affiliated Hospital of Jiangnan University South Campus
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Yangzhou, Jiangsu, Cina, 225001
- Reclutamento
- Northern Jiangsu Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Cina, 330029
- Reclutamento
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, Cina, 110001
- Reclutamento
- The First Hospital of China Medical University
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Shenyang, Liaoning, Cina, 110042
- Reclutamento
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Cina, 710068
- Reclutamento
- Shaanxi Provincial Peoples Hospital
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Shandong
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Jinan, Shandong, Cina, 250000
- Reclutamento
- Shandong Provincial Hospital
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Jining, Shandong, Cina, 272000
- Reclutamento
- Jining No1 Peoples Hospital West Branch
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Qingdao, Shandong, Cina, 266555
- Reclutamento
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200032
- Reclutamento
- Affiliated Zhongshan Hospital of Fudan University
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Shanghai, Shanghai Municipality, Cina, 200000
- Reclutamento
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, Cina, 610041
- Reclutamento
- West China Hospital, Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 301617
- Reclutamento
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310000
- Reclutamento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
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Ningbo, Zhejiang, Cina, 315040
- Reclutamento
- The Affiliated Peoples Hospital of Ningbo University
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Taizhou, Zhejiang, Cina, 317004
- Reclutamento
- Taizhou Hospital of Zhejiang Province (East)
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Busan Gwang'yeogsi
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Seogu, Busan Gwang'yeogsi, Corea del Sud, 49241
- Reclutamento
- Pusan National University Hospital
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Gyeonggi-do
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IlsandongGu GoyangSi, Gyeonggi-do, Corea del Sud, 10408
- Reclutamento
- National Cancer Center (Korea)
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Reclutamento
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Corea del Sud, 06591
- Reclutamento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Corea del Sud, 03722
- Reclutamento
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 03080
- Reclutamento
- Seoul National University Hospital
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Aalborg, Danimarca, 9000
- Reclutamento
- University Hospital of Aalborg
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Copenhagen, Danimarca, 2100
- Reclutamento
- Rigshospitalet
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Køge, Danimarca, 4600
- Reclutamento
- Zealand University Hospital
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Odense, Danimarca, 5000
- Reclutamento
- Odense University Hospital
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ClermontFerrand, Francia, 63100
- Reclutamento
- Chu Clermont Ferrand Therapie Cellulaire and Hematolo
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Nantes, Francia, 44000
- Reclutamento
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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Paris, Francia, 75013
- Reclutamento
- Hopital de La Pitie Salpetriere
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PierreBenite, Francia, 69495
- Reclutamento
- Chu Hopital Lyon Sud
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Reims, Francia, 51100
- Reclutamento
- Hopital Robert Debre
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Rennes Cedes, Francia, 35000
- Reclutamento
- Chu Rennes
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Rouen, Francia, 76038
- Reclutamento
- Centre Henri Becquerel
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Toulouse, Francia, 31100
- Reclutamento
- Iuct Oncopole
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VandoeuvrelesNancy, Francia, 54511
- Reclutamento
- Chu Nancy Hopital Brabois
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Berlin, Germania, 10707
- Reclutamento
- Osp Kurfuerstendamm
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Cologne, Germania, 50937
- Reclutamento
- Uniklinik Koeln (Aoer)
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Dresden, Germania, 01307
- Reclutamento
- Gokos Gmbh
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Jena, Germania, 07747
- Reclutamento
- Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
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Kiel, Germania, 24105
- Reclutamento
- Universitatsklinikum Schleswig Holstein Campus Kiel
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Mutlangen, Germania, 73557
- Reclutamento
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Germania, 81377
- Reclutamento
- Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
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Neubrandenburg, Germania, 17036
- Reclutamento
- Dietrich Bonhoeffer Klinikum Neubrandenburg
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Tübingen, Germania, 72076
- Reclutamento
- Medizinische Universitaetsklinik
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Ulm, Germania, 89081
- Reclutamento
- Universitaetsklinikum Ulm
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Würzburg, Germania, 97080
- Reclutamento
- Haematologisch Onkologische Schwerpunktpraxis
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Dublin, Irlanda, D7
- Reclutamento
- Mater Misericordiae University Hospital
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Dublin, Irlanda, D08 NHY1
- Reclutamento
- St Jamess Hospital
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Galway, Irlanda, H91 YR71
- Reclutamento
- University Hospital Galway
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Limerick, Irlanda, V94F858
- Reclutamento
- University Hospital Limerick
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-
-
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Bari, Italia, 70124
- Reclutamento
- Azienda Ospedaliera Policlinico Di Bari
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Cagliari, Italia, 09121
- Reclutamento
- Ao Brotzu Ospedale Oncologico Armando Businco
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Catania, Italia, 95123
- Reclutamento
- Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
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Ferrara, Italia, 44124
- Reclutamento
- Azienda Ospedaliero Universitaria Di Ferrara
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Milan, Italia, 20132
- Reclutamento
- Ospedale San Raffaele
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Milan, Italia, 20162
- Reclutamento
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Modena, Italia, 41124
- Reclutamento
- Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
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Pagani, Italia, 84014
- Reclutamento
- Asl Salerno Andrea Tortora
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-
-
-
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Auckland, Nuova Zelanda, 1023
- Reclutamento
- Auckland City Hospital
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Auckland, Nuova Zelanda, 0622
- Reclutamento
- North Shore Hospital
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-
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-
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Almere Stad, Olanda, 1315 RA
- Reclutamento
- Flevoziekenhuis
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Arnhem, Olanda, 6815 AD
- Reclutamento
- Rijnstate
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Dordrecht, Olanda, 3318 AT
- Reclutamento
- Albert Schweitzer Ziekenhuis
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Hilversum, Olanda, 1212 VG
- Reclutamento
- Tergooi Mc
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-
-
-
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Lodz, Polonia, 93-510
- Reclutamento
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Torun, Polonia, 87-100
- Reclutamento
- Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
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Wroclaw, Polonia, 50-367
- Reclutamento
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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Bournemouth, Regno Unito, BH7 7DW
- Reclutamento
- University Hospitals Dorset Royal Bournemouth Hospital
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Headington, Regno Unito, OX3 7LE
- Reclutamento
- Oxford University Hospitals Nhs Trust Churchill Hospital
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Leeds, Regno Unito, LS9 7TF
- Reclutamento
- St Jamess University Hospital
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London, Regno Unito, SE5 9RS
- Reclutamento
- Kings College Hospital
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Metropolitan Borough of Wirral, Regno Unito, CH63 4JY
- Reclutamento
- Clatterbridge Cancer Centre
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Newcastle upon Tyne, Regno Unito, NE7 7DN
- Reclutamento
- Freeman Hospital
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Truro, Regno Unito, TR1 3LJ
- Reclutamento
- Royal Cornwall Hospitalsnhs Trust
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-
-
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Barcelona, Spagna, 08036
- Reclutamento
- Hospital Clinic de Barcelona
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Barcelona, Spagna, 08035
- Reclutamento
- Vall D Hebron Institute of Oncology Vhio
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LHospitalet de Llobregat, Spagna, 08908
- Reclutamento
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, Spagna, 28031
- Reclutamento
- Hospital Universitario Infanta Leonor
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Madrid, Spagna, 28006
- Reclutamento
- Hospital de La Princesa
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Marbella, Spagna, 29603
- Reclutamento
- Costa Del Sol (Marbella, Malaga)
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Salamanca, Spagna, 37007
- Reclutamento
- Hospital Universitario de Salamanca
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Santander, Spagna, 39008
- Reclutamento
- Hospital Universitario Marques de Valdecilla
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Seville, Spagna, 41014
- Reclutamento
- Hospital Virgen de Valme (Sevilla)
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California
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Laguna Hills, California, Stati Uniti, 92653
- Reclutamento
- Uci Health Laguna Hills
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Orange, California, Stati Uniti, 92868-3201
- Reclutamento
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Stati Uniti, 94304-2205
- Reclutamento
- Stanford Cancer Institute
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San Diego, California, Stati Uniti, 92103-2106
- Reclutamento
- Scripps Prebys Cancer Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80012-5405
- Reclutamento
- Rocky Mountain Cancer Centers (Williams) Usor
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520-8028
- Reclutamento
- Yale University Yale Cancer Center
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Norwich, Connecticut, Stati Uniti, 06360-2700
- Reclutamento
- Eastern Connecticut Hematology and Oncology
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Florida
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Weston, Florida, Stati Uniti, 33331-3609
- Reclutamento
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Northwestern University
-
Niles, Illinois, Stati Uniti, 60714-5905
- Reclutamento
- Illinois Cancer Specialists (Niles) Usor
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242-1009
- Reclutamento
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Stati Uniti, 50263
- Reclutamento
- Mission Cancer and Blood
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- Reclutamento
- University of Louisville, Brown Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809-3738
- Reclutamento
- Mary Bird Perkins Cancer Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Reclutamento
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215-5418
- Reclutamento
- Dana Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02215-5400
- Reclutamento
- Beth Israel Deaconess Medical Center (Bidmc)
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49503-2563
- Reclutamento
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905-0001
- Reclutamento
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198
- Reclutamento
- University of Nebraska Medical Center
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New Jersey
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Sewell, New Jersey, Stati Uniti, 08080
- Reclutamento
- Sidney Kimmel Comprehensive Cancer Center Washington Twp
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New Mexico
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Santa Fe, New Mexico, Stati Uniti, 87505
- Reclutamento
- Christus St Vincent Regional Cancer Center
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New York
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New York, New York, Stati Uniti, 10065-6800
- Reclutamento
- Memorial Sloan Kettering Cancer Center Mskcc
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Westbury, New York, Stati Uniti, 11590-5119
- Reclutamento
- Optum Medical Care, Pc
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514-4220
- Reclutamento
- University of North Carolina At Chapel Hill
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Charlotte, North Carolina, Stati Uniti, 28204-2990
- Reclutamento
- Levine Cancer Center
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Reclutamento
- Atrium Health Wake Forest Baptist
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45245-1995
- Reclutamento
- Oncology Hematology Care Clinical Trials, Llc
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Oregon
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Eugene, Oregon, Stati Uniti, 97401
- Reclutamento
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Reclutamento
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19107-4216
- Reclutamento
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Stati Uniti, 15232-1309
- Reclutamento
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37404
- Reclutamento
- Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
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Nashville, Tennessee, Stati Uniti, 37205
- Reclutamento
- Tennessee Oncology
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Texas
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Dallas, Texas, Stati Uniti, 75246-2003
- Reclutamento
- Texas Oncology Baylor Charles A Sammons Cancer Center
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San Antonio, Texas, Stati Uniti, 78240-5251
- Reclutamento
- Texas Oncology San Antonio Medical Center Usor
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Tyler, Texas, Stati Uniti, 75702-7522
- Reclutamento
- Texas Oncology Tyler
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Reclutamento
- Swedish Medical Center Swedish Cancer Institute First Hill Campus
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Vancouver, Washington, Stati Uniti, 98684-6930
- Reclutamento
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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-
-
-
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Gothenburg, Svezia, 413 46
- Reclutamento
- Sahlgrenska University Hospital Hematology
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Lund, Svezia, 221 85
- Reclutamento
- Skanes Universitetssjukhus I Lund
-
Stockholm, Svezia, 171 76
- Reclutamento
- Karolinska Universitetssjukhuset Solna
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Uppsala, Svezia, 751 85
- Reclutamento
- Uppsala Akademiska Sjukhus
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination. |
Administered orally
Altri nomi:
Administered intravenously
Altri nomi:
|
|
Sperimentale: Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination. |
Administered orally
Altri nomi:
Administered intravenously
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Administered intravenously
Altri nomi:
|
|
Comparatore attivo: Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination. |
Administered intravenously
Altri nomi:
Administered Orally
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Study Director, BeOne Medicines
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 giugno 2025
Completamento primario (Stimato)
30 settembre 2029
Completamento dello studio (Stimato)
1 dicembre 2031
Date di iscrizione allo studio
Primo inviato
17 aprile 2025
Primo inviato che soddisfa i criteri di controllo qualità
17 aprile 2025
Primo Inserito (Effettivo)
24 aprile 2025
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 ottobre 2026
Ultimo verificato
1 marzo 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Neoplasie
- Malattia cronica
- Attributi della malattia
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Leucemia, linfoide
- Leucemia
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Leucemia, linfocitica, cronica, cellule B
- Aminoacidi, peptidi e proteine
- Proteine
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Anticorpi, monoclonali, derivati da murina
- Rituximab
- Venetoclax
- obinutuzumab
Altri numeri di identificazione dello studio
- BGB-11417-303
- 2024-517131-52-00 (Ctis)
- CLL-RR1 (Altro identificatore: German CLL Study Group)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione IPD
See plan description
Criteri di accesso alla condivisione IPD
See plan description
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .