En undersøgelse til at undersøge progressionsfri overlevelse med Sonrotoclax plus obinutuzumab eller sonrotoclax plus rituximab sammenlignet med venetoclax plus rituximab-behandling hos patienter med tilbagefald og/eller ildfast kronisk lymfocytisk leukemi/lille lymfocytisk lymfom (celestial-rrcll)
21. oktober 2026 opdateret af: BeOne Medicines
En fase 3 randomiseret, open-label, multicenterundersøgelse af Sonrotoclax plus anti-CD20 antistofbehandlinger versus venetoclax plus rituximab hos patienter med tilbagefald/refraktær kronisk lymfocytisk leukæmi/lille lymfocytisk lymfom
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.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
630
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Study Director
- Telefonnummer: 1-877-828-5568
- E-mail: clinicaltrials@beonemed.com
Studiesteder
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Caba, Argentina, CP1114
- Rekruttering
- FUNDALEU
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Caba, Argentina, 1425
- Rekruttering
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1426
- Rekruttering
- Instituto Alexander Fleming (Iaf)
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekruttering
- Blacktown Cancer and Haematology Centre
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Kogarah, New South Wales, Australien, NSW 2217
- Rekruttering
- St George Hospital
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Lismore, New South Wales, Australien, NSW 2480
- Rekruttering
- Northern Nsw Health District
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North Ryde, New South Wales, Australien, NSW 2109
- Rekruttering
- Macquarie University
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St Leonards, New South Wales, Australien, NSW 2065
- Rekruttering
- Genesiscare North Shore
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Queensland
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Birtinya, Queensland, Australien, QLD 4575
- Rekruttering
- Sunshine Coast Hospital and Health Service
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Woolloongabba, Queensland, Australien, QLD 4102
- Rekruttering
- Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Australien, VIC 3168
- Rekruttering
- Monash Health
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Fitzroy, Victoria, Australien, VIC 3065
- Rekruttering
- St Vincents Hospital Melbourne
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Melbourne, Victoria, Australien, VIC 3004
- Rekruttering
- The Alfred Hospital
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Melbourne, Victoria, Australien, VIC 3000
- Rekruttering
- Peter Maccallum Cancer Centre
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Western Australia
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Cooloongup, Western Australia, Australien, WA 6168
- Rekruttering
- Rockingham Hospital
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West Perth, Western Australia, Australien, WA 6005
- Rekruttering
- Perth Blood Institute
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Brussels, Belgien, 1200
- Rekruttering
- Cliniques Universitaires Saint Luc
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Edegem, Belgien, 2650
- Rekruttering
- Uz Antwerpen
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Leuven, Belgien, 3000
- Rekruttering
- University Hospitals Leuven
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Belo Horizonte, Brasilien, 30110-022
- Aktiv, ikke rekrutterende
- CETUS
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Campinas, Brasilien, 13083-878
- Aktiv, ikke rekrutterende
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Curitiba, Brasilien, 81520-060
- Aktiv, ikke rekrutterende
- Hospital Erasto Gaertner
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Niterói, Brasilien, 24020-096
- Aktiv, ikke rekrutterende
- Complexo Hospitalar de Niteroi
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Porto Alegre, Brasilien, 90020-090
- Aktiv, ikke rekrutterende
- Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
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Rio de Janeiro, Brasilien, 22281-100
- Aktiv, ikke rekrutterende
- Instituto Dor de Pesquisa E Ensino Rio de Janeiro
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Rio de Janeiro, Brasilien, 22061-080
- Aktiv, ikke rekrutterende
- Hospital Sao Lucas
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Salvador, Brasilien, 40050-410
- Aktiv, ikke rekrutterende
- Hospital Santa Izabel
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São Paulo, Brasilien, 04014-002
- Aktiv, ikke rekrutterende
- Instituto Brasileiro de Controle Do Cancer
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São Paulo, Brasilien, 01409-001
- Aktiv, ikke rekrutterende
- Hospital Nove de Julho Dasa
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São Paulo, Brasilien, 01232-010
- Aktiv, ikke rekrutterende
- Hospital Samaritano Sao Paulo
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São Paulo, Brasilien, 01401-004
- Aktiv, ikke rekrutterende
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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São Paulo, Brasilien, 05403-010
- Aktiv, ikke rekrutterende
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasilien, 29043-260
- Aktiv, ikke rekrutterende
- Hospital Santa Rita de Cassia Afecc
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Québec, Canada, G1J 1Z4
- Rekruttering
- 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
- Rekruttering
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Rekruttering
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- Rekruttering
- British Columbia Cancer Agency the Vancouver Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Rekruttering
- Cancercare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Rekruttering
- Newfoundland and Labrador Health Services
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Rekruttering
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- Rekruttering
- Ciusss Nim Hscm
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Aalborg, Danmark, 9000
- Rekruttering
- University Hospital of Aalborg
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Copenhagen, Danmark, 2100
- Rekruttering
- Rigshospitalet
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Køge, Danmark, 4600
- Rekruttering
- Zealand University Hospital
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Odense, Danmark, 5000
- Rekruttering
- Odense University Hospital
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Bournemouth, Det Forenede Kongerige, BH7 7DW
- Rekruttering
- University Hospitals Dorset Royal Bournemouth Hospital
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Headington, Det Forenede Kongerige, OX3 7LE
- Rekruttering
- Oxford University Hospitals Nhs Trust Churchill Hospital
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Leeds, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- St Jamess University Hospital
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London, Det Forenede Kongerige, SE5 9RS
- Rekruttering
- Kings College Hospital
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Metropolitan Borough of Wirral, Det Forenede Kongerige, CH63 4JY
- Rekruttering
- Clatterbridge Cancer Centre
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Rekruttering
- Freeman Hospital
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Truro, Det Forenede Kongerige, TR1 3LJ
- Rekruttering
- Royal Cornwall Hospitalsnhs Trust
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California
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Laguna Hills, California, Forenede Stater, 92653
- Rekruttering
- Uci Health Laguna Hills
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Orange, California, Forenede Stater, 92868-3201
- Rekruttering
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forenede Stater, 94304-2205
- Rekruttering
- Stanford Cancer Institute
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San Diego, California, Forenede Stater, 92103-2106
- Rekruttering
- Scripps Prebys Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80012-5405
- Rekruttering
- Rocky Mountain Cancer Centers (Williams) Usor
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520-8028
- Rekruttering
- Yale University Yale Cancer Center
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Norwich, Connecticut, Forenede Stater, 06360-2700
- Rekruttering
- Eastern Connecticut Hematology and Oncology
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Florida
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Weston, Florida, Forenede Stater, 33331-3609
- Rekruttering
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern University
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Niles, Illinois, Forenede Stater, 60714-5905
- Rekruttering
- Illinois Cancer Specialists (Niles) Usor
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242-1009
- Rekruttering
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- Mission Cancer and Blood
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Rekruttering
- University of Louisville, Brown Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809-3738
- Rekruttering
- Mary Bird Perkins Cancer Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215-5418
- Rekruttering
- Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02215-5400
- Rekruttering
- Beth Israel Deaconess Medical Center (Bidmc)
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49503-2563
- Rekruttering
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905-0001
- Rekruttering
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University of Nebraska Medical Center
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New Jersey
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Sewell, New Jersey, Forenede Stater, 08080
- Rekruttering
- Sidney Kimmel Comprehensive Cancer Center Washington Twp
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New Mexico
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Santa Fe, New Mexico, Forenede Stater, 87505
- Rekruttering
- Christus St Vincent Regional Cancer Center
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New York
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New York, New York, Forenede Stater, 10065-6800
- Rekruttering
- Memorial Sloan Kettering Cancer Center Mskcc
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Westbury, New York, Forenede Stater, 11590-5119
- Rekruttering
- Optum Medical Care, Pc
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514-4220
- Rekruttering
- University of North Carolina At Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28204-2990
- Rekruttering
- Levine Cancer Center
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245-1995
- Rekruttering
- Oncology Hematology Care Clinical Trials, Llc
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107-4216
- Rekruttering
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Forenede Stater, 15232-1309
- Rekruttering
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
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Nashville, Tennessee, Forenede Stater, 37205
- Rekruttering
- Tennessee Oncology
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Texas
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Dallas, Texas, Forenede Stater, 75246-2003
- Rekruttering
- Texas Oncology Baylor Charles A Sammons Cancer Center
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San Antonio, Texas, Forenede Stater, 78240-5251
- Rekruttering
- Texas Oncology San Antonio Medical Center Usor
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Tyler, Texas, Forenede Stater, 75702-7522
- Rekruttering
- Texas Oncology Tyler
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Swedish Medical Center Swedish Cancer Institute First Hill Campus
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Vancouver, Washington, Forenede Stater, 98684-6930
- Rekruttering
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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ClermontFerrand, Frankrig, 63100
- Rekruttering
- Chu Clermont Ferrand Therapie Cellulaire and Hematolo
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Nantes, Frankrig, 44000
- Rekruttering
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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Paris, Frankrig, 75013
- Rekruttering
- Hopital de La Pitie Salpetriere
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PierreBenite, Frankrig, 69495
- Rekruttering
- Chu Hopital Lyon Sud
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Reims, Frankrig, 51100
- Rekruttering
- Hopital Robert Debre
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Rennes Cedes, Frankrig, 35000
- Rekruttering
- Chu Rennes
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Rouen, Frankrig, 76038
- Rekruttering
- Centre Henri Becquerel
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Toulouse, Frankrig, 31100
- Rekruttering
- Iuct Oncopole
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VandoeuvrelesNancy, Frankrig, 54511
- Rekruttering
- Chu Nancy Hopital Brabois
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Almere Stad, Holland, 1315 RA
- Rekruttering
- Flevoziekenhuis
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Arnhem, Holland, 6815 AD
- Rekruttering
- Rijnstate
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Dordrecht, Holland, 3318 AT
- Rekruttering
- Albert Schweitzer Ziekenhuis
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Hilversum, Holland, 1212 VG
- Rekruttering
- Tergooi Mc
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Dublin, Irland, D7
- Rekruttering
- Mater Misericordiae University Hospital
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Dublin, Irland, D08 NHY1
- Rekruttering
- St Jamess Hospital
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Galway, Irland, H91 YR71
- Rekruttering
- University Hospital Galway
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Limerick, Irland, V94F858
- Rekruttering
- University Hospital Limerick
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Bari, Italien, 70124
- Rekruttering
- Azienda Ospedaliera Policlinico Di Bari
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Cagliari, Italien, 09121
- Rekruttering
- Ao Brotzu Ospedale Oncologico Armando Businco
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Catania, Italien, 95123
- Rekruttering
- Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
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Ferrara, Italien, 44124
- Rekruttering
- Azienda Ospedaliero Universitaria Di Ferrara
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Milan, Italien, 20132
- Rekruttering
- Ospedale San Raffaele
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Milan, Italien, 20162
- Rekruttering
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Modena, Italien, 41124
- Rekruttering
- Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
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Pagani, Italien, 84014
- Rekruttering
- Asl Salerno Andrea Tortora
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100029
- Rekruttering
- China Japan Friendship Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 630014
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350001
- Rekruttering
- Fujian Provincial Hospital
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Fuzhou, Fujian, Kina, 350005
- Rekruttering
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, Fujian, Kina, 350108
- Rekruttering
- Fujian Medical University Union Hospitalqishan Branch
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Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekruttering
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, Kina, 510013
- Rekruttering
- Guangzhou First Peoples Hospital
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Guangzhou, Guangdong, Kina, 510000
- Rekruttering
- Zhujiang Hospital of Southern Medical University
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Guangxi
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Nanning, Guangxi, Kina, 530201
- Rekruttering
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- Rekruttering
- The Second Hospital of Hebei Medical University
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- Harbin Medical University Cancer Hospital
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Henan
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Xinxiang, Henan, Kina, 453100
- Rekruttering
- The First Affiliated Hospital of Xinxiang Medical University
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Hubei
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Shiyan, Hubei, Kina, 442000
- Rekruttering
- Taihe Hospital
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Wuhan, Hubei, Kina, 430030
- Rekruttering
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina, 410008
- Rekruttering
- Xiangya Hospital of Central South University
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina, 010050
- Rekruttering
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangsu
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Nanjing, Jiangsu, Kina, 210009
- Rekruttering
- Zhongda Hospital Southeast University
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Suzhou, Jiangsu, Kina, 215001
- Rekruttering
- Suzhou Municipal Hospitalbaita Branch
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Wuxi, Jiangsu, Kina, 214122
- Rekruttering
- Affiliated Hospital of Jiangnan University South Campus
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Yangzhou, Jiangsu, Kina, 225001
- Rekruttering
- Northern Jiangsu Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Rekruttering
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, Kina, 110001
- Rekruttering
- The First Hospital of China Medical University
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Shenyang, Liaoning, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Kina, 710068
- Rekruttering
- Shaanxi Provincial Peoples Hospital
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Shandong
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Jinan, Shandong, Kina, 250000
- Rekruttering
- Shandong Provincial Hospital
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Jining, Shandong, Kina, 272000
- Rekruttering
- Jining No1 Peoples Hospital West Branch
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Qingdao, Shandong, Kina, 266555
- Rekruttering
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Affiliated Zhongshan Hospital of Fudan University
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Shanghai, Shanghai Municipality, Kina, 200000
- Rekruttering
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 301617
- Rekruttering
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- Rekruttering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
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Ningbo, Zhejiang, Kina, 315040
- Rekruttering
- The Affiliated Peoples Hospital of Ningbo University
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Taizhou, Zhejiang, Kina, 317004
- Rekruttering
- Taizhou Hospital of Zhejiang Province (East)
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-
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Auckland, New Zealand, 1023
- Rekruttering
- Auckland City Hospital
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Auckland, New Zealand, 0622
- Rekruttering
- North Shore Hospital
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-
-
-
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Lodz, Polen, 93-510
- Rekruttering
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Torun, Polen, 87-100
- Rekruttering
- Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
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Wroclaw, Polen, 50-367
- Rekruttering
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08035
- Rekruttering
- Vall D Hebron Institute of Oncology Vhio
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LHospitalet de Llobregat, Spanien, 08908
- Rekruttering
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, Spanien, 28031
- Rekruttering
- Hospital Universitario Infanta Leonor
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Madrid, Spanien, 28006
- Rekruttering
- Hospital de La Princesa
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Marbella, Spanien, 29603
- Rekruttering
- Costa Del Sol (Marbella, Malaga)
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Salamanca, Spanien, 37007
- Rekruttering
- Hospital Universitario de Salamanca
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Santander, Spanien, 39008
- Rekruttering
- Hospital Universitario Marques de Valdecilla
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Seville, Spanien, 41014
- Rekruttering
- Hospital Virgen de Valme (Sevilla)
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-
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-
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Gothenburg, Sverige, 413 46
- Rekruttering
- Sahlgrenska University Hospital Hematology
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Lund, Sverige, 221 85
- Rekruttering
- Skanes Universitetssjukhus I Lund
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Stockholm, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset Solna
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Uppsala, Sverige, 751 85
- Rekruttering
- Uppsala Akademiska Sjukhus
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-
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Busan Gwang'yeogsi
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Seogu, Busan Gwang'yeogsi, Sydkorea, 49241
- Rekruttering
- Pusan National University Hospital
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Gyeonggi-do
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IlsandongGu GoyangSi, Gyeonggi-do, Sydkorea, 10408
- Rekruttering
- National Cancer Center (Korea)
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Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
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Brno, Tjekkiet, 625 00
- Rekruttering
- Fakultni Nemocnice Brno
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Hradec Králové, Tjekkiet, 500 03
- Rekruttering
- Fakultni Nemocnice Hradec Kralove
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Prague, Tjekkiet, 128 00
- Rekruttering
- Ustav Hematologie A Krevni Transfuze (Uhkt)
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Prague, Tjekkiet, 10000
- Rekruttering
- Vseobecna Fakultni Nemocnice V Praze
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-
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Berlin, Tyskland, 10707
- Rekruttering
- Osp Kurfuerstendamm
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Cologne, Tyskland, 50937
- Rekruttering
- Uniklinik Koeln (Aoer)
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Dresden, Tyskland, 01307
- Rekruttering
- Gokos Gmbh
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Jena, Tyskland, 07747
- Rekruttering
- Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
-
Kiel, Tyskland, 24105
- Rekruttering
- Universitatsklinikum Schleswig Holstein Campus Kiel
-
Mutlangen, Tyskland, 73557
- Rekruttering
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
-
München, Tyskland, 81377
- Rekruttering
- Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
-
Neubrandenburg, Tyskland, 17036
- Rekruttering
- Dietrich Bonhoeffer Klinikum Neubrandenburg
-
Tübingen, Tyskland, 72076
- Rekruttering
- Medizinische Universitaetsklinik
-
Ulm, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm
-
Würzburg, Tyskland, 97080
- Rekruttering
- Haematologisch Onkologische Schwerpunktpraxis
-
-
-
-
-
Innsbruck, Østrig, 6020
- Rekruttering
- Medizinische Universitatsklinik Innsbruck
-
Vienna, Østrig, 1140
- Rekruttering
- Hanusch Krankenhaus
-
Vienna, Østrig, 1090
- Rekruttering
- Medical University Vienna Oncology
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
4
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination. |
Administered orally
Andre navne:
Administered intravenously
Andre navne:
|
|
Eksperimentel: Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination. |
Administered orally
Andre navne:
Administered intravenously
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Administered intravenously
Andre navne:
|
|
Aktiv komparator: Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination. |
Administered intravenously
Andre navne:
Administered Orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Study Director, BeOne Medicines
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
11. juni 2025
Primær færdiggørelse (Anslået)
Primær færdiggørelse
30. september 2029
Studieafslutning (Anslået)
Studieafslutning
1. december 2031
Datoer for studieregistrering
Først indsendt
Først indsendt
17. april 2025
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
17. april 2025
Først opslået (Faktiske)
Først opslået
24. april 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
23. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2026
Sidst verificeret
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Kronisk sygdom
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, B-celle
- Leukæmi, lymfoid
- Leukæmi
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Leukæmi, lymfatisk, kronisk, B-celle
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Antistoffer, monoklonal, murint afledt
- Rituximab
- Venetoclax
- Obinutuzumab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- BGB-11417-303
- 2024-517131-52-00 (Ctis)
- CLL-RR1 (Anden identifikator: German CLL Study Group)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
See plan description
IPD-delingsadgangskriterier
See plan description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .