Un estudio para investigar la supervivencia libre de progresión con Sonrotoclax más obinutuzumab o sonrotoclax más rituximab en comparación con el tratamiento con Venetoclax más rituximab en pacientes con leucemia linfocítica crónica recurrente y/o refractaria/linfocoma linfocítico (Celestial-RRCLL) refractario
21 de octubre de 2026 actualizado por: BeOne Medicines
Un estudio multicéntrico aleatorizado de fase 3 de Fase 3 Terapias de anticuerpos anti-CD20 versus Venetoclax más rituximab en pacientes con leucemia linfocítica crónica recurrente/refractaria/linfoma linfocítico pequeño
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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
630
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Study Director
- Número de teléfono: 1-877-828-5568
- Correo electrónico: clinicaltrials@beonemed.com
Ubicaciones de estudio
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Berlin, Alemania, 10707
- Reclutamiento
- Osp Kurfuerstendamm
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Cologne, Alemania, 50937
- Reclutamiento
- Uniklinik Koeln (Aoer)
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Dresden, Alemania, 01307
- Reclutamiento
- Gokos Gmbh
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Jena, Alemania, 07747
- Reclutamiento
- Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
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Kiel, Alemania, 24105
- Reclutamiento
- Universitatsklinikum Schleswig Holstein Campus Kiel
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Mutlangen, Alemania, 73557
- Reclutamiento
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Alemania, 81377
- Reclutamiento
- Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
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Neubrandenburg, Alemania, 17036
- Reclutamiento
- Dietrich Bonhoeffer Klinikum Neubrandenburg
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Tübingen, Alemania, 72076
- Reclutamiento
- Medizinische Universitaetsklinik
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Ulm, Alemania, 89081
- Reclutamiento
- Universitaetsklinikum Ulm
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Würzburg, Alemania, 97080
- Reclutamiento
- Haematologisch Onkologische Schwerpunktpraxis
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Caba, Argentina, CP1114
- Reclutamiento
- FUNDALEU
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Caba, Argentina, 1425
- Reclutamiento
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1426
- Reclutamiento
- Instituto Alexander Fleming (Iaf)
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Reclutamiento
- Blacktown Cancer and Haematology Centre
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Kogarah, New South Wales, Australia, NSW 2217
- Reclutamiento
- St George Hospital
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Lismore, New South Wales, Australia, NSW 2480
- Reclutamiento
- Northern Nsw Health District
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North Ryde, New South Wales, Australia, NSW 2109
- Reclutamiento
- Macquarie University
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St Leonards, New South Wales, Australia, NSW 2065
- Reclutamiento
- Genesiscare North Shore
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Queensland
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Birtinya, Queensland, Australia, QLD 4575
- Reclutamiento
- Sunshine Coast Hospital and Health Service
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Woolloongabba, Queensland, Australia, QLD 4102
- Reclutamiento
- Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Australia, VIC 3168
- Reclutamiento
- Monash Health
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Fitzroy, Victoria, Australia, VIC 3065
- Reclutamiento
- St Vincents Hospital Melbourne
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Melbourne, Victoria, Australia, VIC 3004
- Reclutamiento
- The Alfred Hospital
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Melbourne, Victoria, Australia, VIC 3000
- Reclutamiento
- Peter Maccallum Cancer Centre
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Western Australia
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Cooloongup, Western Australia, Australia, WA 6168
- Reclutamiento
- Rockingham Hospital
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West Perth, Western Australia, Australia, WA 6005
- Reclutamiento
- Perth Blood Institute
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Innsbruck, Austria, 6020
- Reclutamiento
- Medizinische Universitatsklinik Innsbruck
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Vienna, Austria, 1140
- Reclutamiento
- Hanusch Krankenhaus
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Vienna, Austria, 1090
- Reclutamiento
- Medical University Vienna Oncology
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Belo Horizonte, Brasil, 30110-022
- Activo, no reclutando
- CETUS
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Campinas, Brasil, 13083-878
- Activo, no reclutando
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Curitiba, Brasil, 81520-060
- Activo, no reclutando
- Hospital Erasto Gaertner
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Niterói, Brasil, 24020-096
- Activo, no reclutando
- Complexo Hospitalar de Niteroi
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Porto Alegre, Brasil, 90020-090
- Activo, no reclutando
- Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
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Rio de Janeiro, Brasil, 22281-100
- Activo, no reclutando
- Instituto Dor de Pesquisa E Ensino Rio de Janeiro
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Rio de Janeiro, Brasil, 22061-080
- Activo, no reclutando
- Hospital Sao Lucas
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Salvador, Brasil, 40050-410
- Activo, no reclutando
- Hospital Santa Izabel
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São Paulo, Brasil, 04014-002
- Activo, no reclutando
- Instituto Brasileiro de Controle Do Cancer
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São Paulo, Brasil, 01409-001
- Activo, no reclutando
- Hospital Nove de Julho Dasa
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São Paulo, Brasil, 01232-010
- Activo, no reclutando
- Hospital Samaritano Sao Paulo
-
São Paulo, Brasil, 01401-004
- Activo, no reclutando
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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São Paulo, Brasil, 05403-010
- Activo, no reclutando
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasil, 29043-260
- Activo, no reclutando
- Hospital Santa Rita de Cassia Afecc
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Brussels, Bélgica, 1200
- Reclutamiento
- Cliniques Universitaires Saint Luc
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Edegem, Bélgica, 2650
- Reclutamiento
- Uz Antwerpen
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Leuven, Bélgica, 3000
- Reclutamiento
- University Hospitals Leuven
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Québec, Canadá, G1J 1Z4
- Reclutamiento
- 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
- Reclutamiento
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Reclutamiento
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- Reclutamiento
- British Columbia Cancer Agency the Vancouver Centre
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- Reclutamiento
- Cancercare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Reclutamiento
- Newfoundland and Labrador Health Services
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Reclutamiento
- The Ottawa Hospital
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Toronto, Ontario, Canadá, M5G 2M9
- Reclutamiento
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canadá, H4J 1C5
- Reclutamiento
- Ciusss Nim Hscm
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Brno, Chequia, 625 00
- Reclutamiento
- Fakultni Nemocnice Brno
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Hradec Králové, Chequia, 500 03
- Reclutamiento
- Fakultni Nemocnice Hradec Kralove
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Prague, Chequia, 128 00
- Reclutamiento
- Ustav Hematologie A Krevni Transfuze (Uhkt)
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Prague, Chequia, 10000
- Reclutamiento
- Vseobecna Fakultni Nemocnice V Praze
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-
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Busan Gwang'yeogsi
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Seogu, Busan Gwang'yeogsi, Corea del Sur, 49241
- Reclutamiento
- Pusan National University Hospital
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Gyeonggi-do
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IlsandongGu GoyangSi, Gyeonggi-do, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center (Korea)
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Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Reclutamiento
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Corea del Sur, 06591
- Reclutamiento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Aalborg, Dinamarca, 9000
- Reclutamiento
- University Hospital of Aalborg
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Copenhagen, Dinamarca, 2100
- Reclutamiento
- Rigshospitalet
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Køge, Dinamarca, 4600
- Reclutamiento
- Zealand University Hospital
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Odense, Dinamarca, 5000
- Reclutamiento
- Odense University Hospital
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Barcelona, España, 08035
- Reclutamiento
- Vall D Hebron Institute of Oncology Vhio
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LHospitalet de Llobregat, España, 08908
- Reclutamiento
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, España, 28031
- Reclutamiento
- Hospital Universitario Infanta Leonor
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Madrid, España, 28006
- Reclutamiento
- Hospital de La Princesa
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Marbella, España, 29603
- Reclutamiento
- Costa Del Sol (Marbella, Malaga)
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Salamanca, España, 37007
- Reclutamiento
- Hospital Universitario de Salamanca
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Santander, España, 39008
- Reclutamiento
- Hospital Universitario Marques de Valdecilla
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Seville, España, 41014
- Reclutamiento
- Hospital Virgen de Valme (Sevilla)
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California
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Laguna Hills, California, Estados Unidos, 92653
- Reclutamiento
- Uci Health Laguna Hills
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Orange, California, Estados Unidos, 92868-3201
- Reclutamiento
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Estados Unidos, 94304-2205
- Reclutamiento
- Stanford Cancer Institute
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San Diego, California, Estados Unidos, 92103-2106
- Reclutamiento
- Scripps Prebys Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80012-5405
- Reclutamiento
- Rocky Mountain Cancer Centers (Williams) Usor
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Reclutamiento
- Yale University Yale Cancer Center
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Norwich, Connecticut, Estados Unidos, 06360-2700
- Reclutamiento
- Eastern Connecticut Hematology and Oncology
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Florida
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Weston, Florida, Estados Unidos, 33331-3609
- Reclutamiento
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Reclutamiento
- Northwestern University
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Niles, Illinois, Estados Unidos, 60714-5905
- Reclutamiento
- Illinois Cancer Specialists (Niles) Usor
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Reclutamiento
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Estados Unidos, 50263
- Reclutamiento
- Mission Cancer and Blood
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Reclutamiento
- University of Louisville, Brown Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809-3738
- Reclutamiento
- Mary Bird Perkins Cancer Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Reclutamiento
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215-5418
- Reclutamiento
- Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02215-5400
- Reclutamiento
- Beth Israel Deaconess Medical Center (Bidmc)
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503-2563
- Reclutamiento
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905-0001
- Reclutamiento
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198
- Reclutamiento
- University of Nebraska Medical Center
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New Jersey
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Sewell, New Jersey, Estados Unidos, 08080
- Reclutamiento
- Sidney Kimmel Comprehensive Cancer Center Washington Twp
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New Mexico
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Santa Fe, New Mexico, Estados Unidos, 87505
- Reclutamiento
- Christus St Vincent Regional Cancer Center
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New York
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New York, New York, Estados Unidos, 10065-6800
- Reclutamiento
- Memorial Sloan Kettering Cancer Center Mskcc
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Westbury, New York, Estados Unidos, 11590-5119
- Reclutamiento
- Optum Medical Care, Pc
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514-4220
- Reclutamiento
- University of North Carolina At Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28204-2990
- Reclutamiento
- Levine Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Reclutamiento
- Atrium Health Wake Forest Baptist
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45245-1995
- Reclutamiento
- Oncology Hematology Care Clinical Trials, Llc
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Reclutamiento
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Reclutamiento
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107-4216
- Reclutamiento
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Estados Unidos, 15232-1309
- Reclutamiento
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Reclutamiento
- Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
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Nashville, Tennessee, Estados Unidos, 37205
- Reclutamiento
- Tennessee Oncology
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Texas
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Dallas, Texas, Estados Unidos, 75246-2003
- Reclutamiento
- Texas Oncology Baylor Charles A Sammons Cancer Center
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San Antonio, Texas, Estados Unidos, 78240-5251
- Reclutamiento
- Texas Oncology San Antonio Medical Center Usor
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Tyler, Texas, Estados Unidos, 75702-7522
- Reclutamiento
- Texas Oncology Tyler
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Reclutamiento
- Swedish Medical Center Swedish Cancer Institute First Hill Campus
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Vancouver, Washington, Estados Unidos, 98684-6930
- Reclutamiento
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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ClermontFerrand, Francia, 63100
- Reclutamiento
- Chu Clermont Ferrand Therapie Cellulaire and Hematolo
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Nantes, Francia, 44000
- Reclutamiento
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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Paris, Francia, 75013
- Reclutamiento
- Hopital de La Pitie Salpetriere
-
PierreBenite, Francia, 69495
- Reclutamiento
- Chu Hopital Lyon Sud
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Reims, Francia, 51100
- Reclutamiento
- Hopital Robert Debre
-
Rennes Cedes, Francia, 35000
- Reclutamiento
- Chu Rennes
-
Rouen, Francia, 76038
- Reclutamiento
- Centre Henri Becquerel
-
Toulouse, Francia, 31100
- Reclutamiento
- Iuct Oncopole
-
VandoeuvrelesNancy, Francia, 54511
- Reclutamiento
- Chu Nancy Hopital Brabois
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-
-
-
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Dublin, Irlanda, D7
- Reclutamiento
- Mater Misericordiae University Hospital
-
Dublin, Irlanda, D08 NHY1
- Reclutamiento
- St Jamess Hospital
-
Galway, Irlanda, H91 YR71
- Reclutamiento
- University Hospital Galway
-
Limerick, Irlanda, V94F858
- Reclutamiento
- University Hospital Limerick
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-
-
-
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Bari, Italia, 70124
- Reclutamiento
- Azienda Ospedaliera Policlinico Di Bari
-
Cagliari, Italia, 09121
- Reclutamiento
- Ao Brotzu Ospedale Oncologico Armando Businco
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Catania, Italia, 95123
- Reclutamiento
- Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
-
Ferrara, Italia, 44124
- Reclutamiento
- Azienda Ospedaliero Universitaria Di Ferrara
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Milan, Italia, 20132
- Reclutamiento
- Ospedale San Raffaele
-
Milan, Italia, 20162
- Reclutamiento
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Modena, Italia, 41124
- Reclutamiento
- Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
-
Pagani, Italia, 84014
- Reclutamiento
- Asl Salerno Andrea Tortora
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-
-
-
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Auckland, Nueva Zelanda, 1023
- Reclutamiento
- Auckland City Hospital
-
Auckland, Nueva Zelanda, 0622
- Reclutamiento
- North Shore Hospital
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-
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-
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Almere Stad, Países Bajos, 1315 RA
- Reclutamiento
- Flevoziekenhuis
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Arnhem, Países Bajos, 6815 AD
- Reclutamiento
- Rijnstate
-
Dordrecht, Países Bajos, 3318 AT
- Reclutamiento
- Albert Schweitzer Ziekenhuis
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Hilversum, Países Bajos, 1212 VG
- Reclutamiento
- Tergooi Mc
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-
-
-
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Lodz, Polonia, 93-510
- Reclutamiento
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Torun, Polonia, 87-100
- Reclutamiento
- Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
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Wroclaw, Polonia, 50-367
- Reclutamiento
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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-
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- China Japan Friendship Hospital
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Chongqing Municipality
-
Chongqing, Chongqing Municipality, Porcelana, 630014
- Reclutamiento
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Porcelana, 350001
- Reclutamiento
- Fujian Provincial Hospital
-
Fuzhou, Fujian, Porcelana, 350005
- Reclutamiento
- The First Affiliated Hospital of Fujian Medical University
-
Fuzhou, Fujian, Porcelana, 350108
- Reclutamiento
- Fujian Medical University Union Hospitalqishan Branch
-
Xiamen, Fujian, Porcelana, 361003
- Reclutamiento
- The First Affiliated Hospital of Xiamen University
-
-
Guangdong
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Guangzhou, Guangdong, Porcelana, 510515
- Reclutamiento
- Nanfang Hospital, Southern Medical University
-
Guangzhou, Guangdong, Porcelana, 510013
- Reclutamiento
- Guangzhou First Peoples Hospital
-
Guangzhou, Guangdong, Porcelana, 510000
- Reclutamiento
- Zhujiang Hospital of Southern Medical University
-
-
Guangxi
-
Nanning, Guangxi, Porcelana, 530201
- Reclutamiento
- Guangxi Medical University Cancer Hospital Wuxiang Branch
-
-
Hebei
-
Shijiazhuang, Hebei, Porcelana, 050000
- Reclutamiento
- The Second Hospital of Hebei Medical University
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-
Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150000
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Henan
-
Xinxiang, Henan, Porcelana, 453100
- Reclutamiento
- The First Affiliated Hospital of Xinxiang Medical University
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Hubei
-
Shiyan, Hubei, Porcelana, 442000
- Reclutamiento
- Taihe Hospital
-
Wuhan, Hubei, Porcelana, 430030
- Reclutamiento
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, Porcelana, 410008
- Reclutamiento
- Xiangya Hospital of Central South University
-
-
Inner Mongolia
-
Hohhot, Inner Mongolia, Porcelana, 010050
- Reclutamiento
- The Affiliated Hospital of Inner Mongolia Medical University
-
-
Jiangsu
-
Nanjing, Jiangsu, Porcelana, 210009
- Reclutamiento
- Zhongda Hospital Southeast University
-
Suzhou, Jiangsu, Porcelana, 215001
- Reclutamiento
- Suzhou Municipal Hospitalbaita Branch
-
Wuxi, Jiangsu, Porcelana, 214122
- Reclutamiento
- Affiliated Hospital of Jiangnan University South Campus
-
Yangzhou, Jiangsu, Porcelana, 225001
- Reclutamiento
- Northern Jiangsu Peoples Hospital
-
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Jiangxi
-
Nanchang, Jiangxi, Porcelana, 330029
- Reclutamiento
- Jiangxi Cancer Hospital
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Liaoning
-
Shenyang, Liaoning, Porcelana, 110001
- Reclutamiento
- The First Hospital of China Medical University
-
Shenyang, Liaoning, Porcelana, 110042
- Reclutamiento
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710068
- Reclutamiento
- Shaanxi Provincial Peoples Hospital
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Shandong
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Jinan, Shandong, Porcelana, 250000
- Reclutamiento
- Shandong Provincial Hospital
-
Jining, Shandong, Porcelana, 272000
- Reclutamiento
- Jining No1 Peoples Hospital West Branch
-
Qingdao, Shandong, Porcelana, 266555
- Reclutamiento
- The Affiliated Hospital of Qingdao University Branch West Coast
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, Porcelana, 200032
- Reclutamiento
- Affiliated Zhongshan Hospital of Fudan University
-
Shanghai, Shanghai Municipality, Porcelana, 200000
- Reclutamiento
- Fudan University Shanghai Cancer Center
-
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Sichuan
-
Chengdu, Sichuan, Porcelana, 610041
- Reclutamiento
- West China Hospital, Sichuan University
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Porcelana, 301617
- Reclutamiento
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
-
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Zhejiang
-
Hangzhou, Zhejiang, Porcelana, 310000
- Reclutamiento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
-
Ningbo, Zhejiang, Porcelana, 315040
- Reclutamiento
- The Affiliated Peoples Hospital of Ningbo University
-
Taizhou, Zhejiang, Porcelana, 317004
- Reclutamiento
- Taizhou Hospital of Zhejiang Province (East)
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-
-
-
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Bournemouth, Reino Unido, BH7 7DW
- Reclutamiento
- University Hospitals Dorset Royal Bournemouth Hospital
-
Headington, Reino Unido, OX3 7LE
- Reclutamiento
- Oxford University Hospitals Nhs Trust Churchill Hospital
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Leeds, Reino Unido, LS9 7TF
- Reclutamiento
- St Jamess University Hospital
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London, Reino Unido, SE5 9RS
- Reclutamiento
- Kings College Hospital
-
Metropolitan Borough of Wirral, Reino Unido, CH63 4JY
- Reclutamiento
- Clatterbridge Cancer Centre
-
Newcastle upon Tyne, Reino Unido, NE7 7DN
- Reclutamiento
- Freeman Hospital
-
Truro, Reino Unido, TR1 3LJ
- Reclutamiento
- Royal Cornwall Hospitalsnhs Trust
-
-
-
-
-
Gothenburg, Suecia, 413 46
- Reclutamiento
- Sahlgrenska University Hospital Hematology
-
Lund, Suecia, 221 85
- Reclutamiento
- Skanes Universitetssjukhus I Lund
-
Stockholm, Suecia, 171 76
- Reclutamiento
- Karolinska Universitetssjukhuset Solna
-
Uppsala, Suecia, 751 85
- Reclutamiento
- Uppsala Akademiska Sjukhus
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination. |
Administered orally
Otros nombres:
Administered intravenously
Otros nombres:
|
|
Experimental: Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination. |
Administered orally
Otros nombres:
Administered intravenously
Otros nombres:
|
|
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
Otros nombres:
Administered intravenously
Otros nombres:
|
|
Comparador activo: Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination. |
Administered intravenously
Otros nombres:
Administered Orally
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Study Director, BeOne Medicines
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de junio de 2025
Finalización primaria (Estimado)
30 de septiembre de 2029
Finalización del estudio (Estimado)
1 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
17 de abril de 2025
Primero enviado que cumplió con los criterios de control de calidad
17 de abril de 2025
Publicado por primera vez (Actual)
24 de abril de 2025
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Leucemia de células B
- Leucemia Linfoide
- Leucemia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Leucemia Linfocítica Crónica De Células B
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Anticuerpos, monoclonales, derivados de murino
- Rituximab
- venetoclax
- obinutuzumab
Otros números de identificación del estudio
- BGB-11417-303
- 2024-517131-52-00 (Ctis)
- CLL-RR1 (Otro identificador: German CLL Study Group)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
See plan description
Criterios de acceso compartido de IPD
See plan description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .