En undersøgelse af Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) i andenlinje (2L) + recidiverende/refraktær (R/R) kronisk lymfatisk leukæmi/lille lymfatisk lymfom (CLL/SLL) (MK-1026-010/BELLWAVE- 010)
4. november 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3, åbent, randomiseret studie for at sammenligne effektiviteten og sikkerheden af Nemtabrutinib (MK-1026) Plus Venetoclax versus Venetoclax Plus Rituximab hos deltagere med recidiverende/refraktær kronisk lymfatisk leukæmi/lille lymfatisk lymfom 1, der følger ved LeastAVE eller Therapy -010)
The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
735
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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Buenos Aires, Argentina, 1414
- Rekruttering
- Centro Medico Fleischer ( Site 1006)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541148544097
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Buenos Aires, Argentina, C1118AAT
- Rekruttering
- Hospital Aleman-oncohematologic diseases ( Site 1001)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541148277000
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming ( Site 1005)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541132218900
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Rekruttering
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
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Kontakt:
- Study Coordinator
- Telefonnummer: +542234963224
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
- Rekruttering
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541152991200
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Rekruttering
- Sanatorio Parque ( Site 1003)
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Kontakt:
- Study Coordinator
- Telefonnummer: +543414200222
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekruttering
- Royal Adelaide Hospital ( Site 1104)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61870740000
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Victoria
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Box Hill, Victoria, Australien, 3128
- Rekruttering
- Box Hill Hospital ( Site 1106)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61438659719
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Melbourne, Victoria, Australien, 3021
- Rekruttering
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61383959130
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Antwerp, Belgien, 2030
- Rekruttering
- ZAS Cadix ( Site 1203)
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Kontakt:
- Study Coordinator
- Telefonnummer: +32 3/339 76 38
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgien, 3000
- Rekruttering
- UZ Leuven-Hematology ( Site 1200)
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Kontakt:
- Study Coordinator
- Telefonnummer: +32 16/338544
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São Paulo, Brasilien, 01246-000
- Aktiv, ikke rekrutterende
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
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São Paulo, Brasilien, 01321-001
- Rekruttering
- Hospital Paulistano-Americas Oncologia ( Site 1302)
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Kontakt:
- Study Coordinator
- Telefonnummer: +5511992926463
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São Paulo
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Jaú, São Paulo, Brasilien, 17210-120
- Rekruttering
- Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
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Kontakt:
- Study Coordinator
- Telefonnummer: 5514991337515
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
- Rekruttering
- The Moncton Hospital ( Site 1414)
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Kontakt:
- Study Coordinator
- Telefonnummer: 506-870-2404
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Rekruttering
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1416)
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Kontakt:
- Study Coordinator
- Telefonnummer: 6479217469
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Rekruttering
- Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402)
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Kontakt:
- Study Coordinator
- Telefonnummer: 450-466-5000 x3226
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Sherbrooke, Quebec, Canada, J1H 5H4
- Rekruttering
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410)
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Kontakt:
- Study Coordinator
- Telefonnummer: 819-346-1110 x12811
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Biobio
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Concepción, Biobio, Chile, 4070196
- Rekruttering
- Biocenter ( Site 1507)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56412858421
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- Rekruttering
- IC La Serena Research ( Site 1506)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56958646664
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500653
- Rekruttering
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56991612199
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- FALP-UIDO ( Site 1500)
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Kontakt:
- Study Coordinator
- Telefonnummer: 56224205098
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Santiago, Region M. de Santiago, Chile, 7580206
- Rekruttering
- Clínica Inmunocel ( Site 1511)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56224376600
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Santiago, Region M. de Santiago, Chile, 7650568
- Rekruttering
- Clinica Alemana de Santiago ( Site 1514)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56996197211
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradfordhill ( Site 1512)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56229490970
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Antioquia
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Medellín, Antioquia, Colombia, 050030
- Rekruttering
- Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)
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Kontakt:
- Study Coordinator
- Telefonnummer: +576044480016Ext2204
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Rekruttering
- Fundación Valle del Lili ( Site 1703)
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Kontakt:
- Study Coordinator
- Telefonnummer: 57 3133288646
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England
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Nottingham, England, Det Forenede Kongerige, NG5 1PF
- Rekruttering
- City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
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Kontakt:
- Study Coordinator
- Telefonnummer: +44115969116972549
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London, City of
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London-Camden, London, City of, Det Forenede Kongerige, NW1 2PG
- Rekruttering
- University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4420 3447 2528
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Arkansas
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Springdale, Arkansas, Forenede Stater, 72762
- Rekruttering
- Highlands Oncology Group ( Site 5405)
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Kontakt:
- Study Coordinator
- Telefonnummer: 479-872-8130
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California
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Long Beach, California, Forenede Stater, 90806
- Rekruttering
- MemorialCare Health System - Long Beach Medical Center ( Site 5421)
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Kontakt:
- Study Coordinator
- Telefonnummer: 562-933-7866
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Florida
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Clermont, Florida, Forenede Stater, 34711
- Rekruttering
- Clermont Oncology Center ( Site 5430)
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Kontakt:
- Study Coordinator
- Telefonnummer: 386-538-3169
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Pembroke Pines, Florida, Forenede Stater, 33028
- Rekruttering
- Memorial Hospital West ( Site 5410)
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Kontakt:
- Study Coordinator
- Telefonnummer: 954-844-8318
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- Rekruttering
- Fort Wayne Medical Oncology and Hematology ( Site 5444)
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Kontakt:
- Study Coordinator
- Telefonnummer: 260-436-0800
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Maryland
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Bethesda, Maryland, Forenede Stater, 20817
- Rekruttering
- Center for Cancer and Blood Disorders ( Site 5439)
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Kontakt:
- Study Coordinator
- Telefonnummer: 301-571-2016
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Minnesota
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Marshall, Minnesota, Forenede Stater, 56258
- Rekruttering
- Avera Cancer Institute - Marshall ( Site 5462)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-601-1830
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Rekruttering
- Hattiesburg Clinic Hematology/Oncology ( Site 5416)
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Kontakt:
- Study Coordinator
- Telefonnummer: 601-261-1700
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Missouri
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Kansas City, Missouri, Forenede Stater, 64132
- Rekruttering
- MidAmerica Cancer Care, LLC ( Site 5426)
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Kontakt:
- Study Coordinator
- Telefonnummer: 816-974-5050
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Montana
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Billings, Montana, Forenede Stater, 59102
- Rekruttering
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 5433)
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Kontakt:
- Study Coordinator
- Telefonnummer: 406-238-6685
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Rekruttering
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 5434)
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Kontakt:
- Study Coordinator
- Telefonnummer: 775-982-4000
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New Jersey
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Morristown, New Jersey, Forenede Stater, 07960
- Rekruttering
- Atlantic Health System Morristown Medical Center ( Site 5445)
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Kontakt:
- Study Coordinator
- Telefonnummer: 973-971-5000
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New York
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Albany, New York, Forenede Stater, 12208
- Rekruttering
- New York Oncology Hematology, P.C. ( Site 5453)
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Kontakt:
- Study Coordinator
- Telefonnummer: 518-262-6696
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Oregon
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Portland, Oregon, Forenede Stater, 97239-3011
- Rekruttering
- Oregon Health and Science University ( Site 5425)
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Kontakt:
- Study Coordinator
- Telefonnummer: 503-494-5058
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South Dakota
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Aberdeen, South Dakota, Forenede Stater, 57401
- Rekruttering
- Avera Cancer Institute - Aberdeen ( Site 5458)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-601-1830
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Mitchell, South Dakota, Forenede Stater, 57301
- Rekruttering
- Avera Cancer Institute - Mitchell ( Site 5461)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-322-3299
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Pierre, South Dakota, Forenede Stater, 57501
- Rekruttering
- Avera Cancer Institute - Pierre ( Site 5460)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-601-1830
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Rekruttering
- Avera Cancer Institute- Research ( Site 5437)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-322-3035
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Yankton, South Dakota, Forenede Stater, 57078
- Rekruttering
- Avera Cancer Institute - Yankton ( Site 5459)
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Kontakt:
- Study Coordinator
- Telefonnummer: 605-601-1830
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Texas
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Sugar Land, Texas, Forenede Stater, 77479
- Rekruttering
- PatientCare Clinical Research LLC ( Site 5435)
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Kontakt:
- Study Coordinator
- Telefonnummer: 929-712-7467
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- Rekruttering
- University of Virginia Cancer Center ( Site 5402)
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Kontakt:
- Study Coordinator
- Telefonnummer: 434-924-9333
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Washington
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Olympia, Washington, Forenede Stater, 98506
- Rekruttering
- Vista Oncology ( Site 5449)
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Kontakt:
- Study Coordinator
- Telefonnummer: 360-413-8880
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Spokane, Washington, Forenede Stater, 99208
- Rekruttering
- Medical Oncology Associates, PS ( Site 5406)
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Kontakt:
- Study Coordinator
- Telefonnummer: 509-462-2273
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- Rekruttering
- West Virginia University ( Site 5447)
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Kontakt:
- Study Coordinator
- Telefonnummer: 304-598-4500
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Afsluttet
- University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
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Nord
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Lille, Nord, Frankrig, 59037
- Rekruttering
- Hopital Claude Huriez - CHU de Lille ( Site 2107)
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Kontakt:
- Study Coordinator
- Telefonnummer: +333 20 44 59 62
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Puy-de-Dome
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Clermont-Ferrand, Puy-de-Dome, Frankrig, 63100
- Rekruttering
- Centre Hospitalier Universitaire Estaing ( Site 2105)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33473750065
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Vendee
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La Roche-sur-Yon, Vendee, Frankrig, 85925
- Rekruttering
- CHD Vendee ( Site 2100)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33251446572
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Attica
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Athens, Attica, Grækenland, 106 76
- Rekruttering
- Evangelismos General Hospital of Athens ( Site 2302)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2132041721
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Athens, Attica, Grækenland, 115 27
- Rekruttering
- General Hospital of Athens "Laiko" ( Site 2308)
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Kontakt:
- Study Coordinator
- Telefonnummer: +302132061702
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Athens, Attica, Grækenland, 115 27
- Rekruttering
- General Hospital of Athens "Laiko" ( Site 2309)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2132061643
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East Macedonia and Thrace
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Alexandroupoli, East Macedonia and Thrace, Grækenland, 681 00
- Rekruttering
- GENERAL HOSPITAL OF ALEXANDROUPOLI ( Site 2310)
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Kontakt:
- Study Coordinator
- Telefonnummer: +302551030320
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus ( Site 2801)
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Kontakt:
- Study Coordinator
- Telefonnummer: +97247771514
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Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center-Hemato-Oncology ( Site 2812)
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Kontakt:
- Study Coordinator
- Telefonnummer: +972-539101736
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Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center-Hemato Oncology ( Site 2809)
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Kontakt:
- Study Coordinator
- Telefonnummer: +972-35308401
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Tel Aviv, Israel, 6423906
- Rekruttering
- Sourasky Medical Center ( Site 2811)
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Kontakt:
- Study Coordinator
- Telefonnummer: +97237772649
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Alessandria, Italien, 15121
- Rekruttering
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390131206440
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Milan, Italien, 20132
- Rekruttering
- Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390226436119
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Reggio Emilia, Italien, 42123
- Rekruttering
- Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390522295654
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Hiroshima, Japan, 730-8619
- Rekruttering
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3006)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-82-241-3111
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Nagasaki, Japan, 852-8501
- Rekruttering
- Nagasaki University Hospital ( Site 3008)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-95-819-7200
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Osaka, Japan, 540-0006
- Rekruttering
- National Hospital Organization Osaka National Hospital ( Site 3004)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-6-6942-1331
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Yamagata, Japan, 990-9585
- Rekruttering
- Yamagata University Hospital ( Site 3002)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-23-633-1122
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 3000)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Rekruttering
- Kochi Medical School Hospital ( Site 3007)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-88-866-5811
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Osaka
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Sakai, Osaka, Japan, 590-0197
- Rekruttering
- Kindai University Hospital ( Site 3005)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-72-288-7222
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Shimane
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Izumo, Shimane, Japan, 693-8501
- Rekruttering
- Shimane University Hospital ( Site 3009)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-853-23-2111
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Tokyo
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Koto, Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR ( Site 3003)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-3-3520-0111
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Mexico City
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Mexico City, Mexico City, Mexico, 03100
- Rekruttering
- Centro de Infusion Superare ( Site 3314)
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Kontakt:
- Study Coordinator
- Telefonnummer: +52 55 5264 6440
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Mexico City, Mexico City, Mexico, 03100
- Rekruttering
- Health Pharma Professional Research S.A. de C.V: ( Site 3301)
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Kontakt:
- Study Coordinator
- Telefonnummer: +52 55 7586 4856
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Michoacán
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Morelia, Michoacán, Mexico, 58260
- Rekruttering
- Centro de Investigacion Clinica Chapultepec ( Site 3309)
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Kontakt:
- Study Coordinator
- Telefonnummer: +52 443 147 8545
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Auckland, New Zealand, 0622
- Rekruttering
- North Shore Hospital-Department of Haematology ( Site 3505)
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Kontakt:
- Study Coordinator
- Telefonnummer: +6494868920x49725
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Auckland, New Zealand, 2025
- Rekruttering
- Aotearoa Clinical Trials ( Site 3504)
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Kontakt:
- Study Coordinator
- Telefonnummer: +6433640386
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Canterbury
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Christchurch, Canterbury, New Zealand, 8011
- Rekruttering
- Christchurch Hospital ( Site 3503)
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Kontakt:
- Study Coordinator
- Telefonnummer: +6433640386
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Manawatu-Wanganui
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Palmerston North, Manawatu-Wanganui, New Zealand, 4414
- Rekruttering
- Palmerston North Hospital ( Site 3506)
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Kontakt:
- Study Coordinator
- Telefonnummer: +6463509169
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Porto, Portugal, 4200-072
- Rekruttering
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3800)
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Kontakt:
- Study Coordinator
- Telefonnummer: 00351225084000
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San Juan, Puerto Rico, 00918
- Rekruttering
- Auxilio Mutuo Cancer Center ( Site 3900)
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Kontakt:
- Study Coordinator
- Telefonnummer: 7877582000
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San Juan, Puerto Rico, 00917
- Rekruttering
- BRCR Global Puerto Rico - Hato Rey ( Site 3901)
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Kontakt:
- Study Coordinator
- Telefonnummer: +17875612375195
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Barcelona
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L'Hospitalet Del Llobregat, Barcelona, Spanien, 08908
- Rekruttering
- Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34932607750
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Rekruttering
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
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Kontakt:
- Study Coordinator
- Telefonnummer: 914521900
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spanien, 46010
- Rekruttering
- HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
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Kontakt:
- Study Coordinator
- Telefonnummer: 961973930
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Gauteng
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Pretoria, Gauteng, Sydafrika, 0181
- Rekruttering
- Alberts Cellular Therapy. ( Site 4401)
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Kontakt:
- Study Coordinator
- Telefonnummer: +27 12 993 2555
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Western Cape
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Cape Town, Western Cape, Sydafrika, 7925
- Rekruttering
- Groote Schuur Hospital ( Site 4400)
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Kontakt:
- Study Coordinator
- Telefonnummer: +27727689024
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Kuilsriver, Western Cape, Sydafrika, 7580
- Rekruttering
- Haemalife ( Site 4407)
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Kontakt:
- Study Coordinator
- Telefonnummer: +27 21 900 6277
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Kaohsiung City, Taiwan, 83301
- Rekruttering
- Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
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Kontakt:
- Study Coordinator
- Telefonnummer: +88677317123
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Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital ( Site 4701)
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Kontakt:
- Study Coordinator
- Telefonnummer: +88662353535
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Taipei, Taiwan, 10048
- Rekruttering
- National Taiwan University Hospital ( Site 4704)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886223123456
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Taipei
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Taipei City, Taipei, Taiwan, 114
- Rekruttering
- Tri-Service General Hospital-hematology&oncology ( Site 4703)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +886287923311
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06100
- Afsluttet
- Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
-
Istanbul, Tyrkiet (Türkiye), 34214
- Rekruttering
- Mega Medipol-Hematology ( Site 4904)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0212 444 70 44
-
Istanbul, Tyrkiet (Türkiye), 34722
- Rekruttering
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0090 216 606 52 00
-
Istanbul, Tyrkiet (Türkiye), 34381
- Rekruttering
- Sisli Florence Nightingale Hastanesi ( Site 4916)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 905348310606
-
-
Tekirdas
-
Tekirdağ, Tekirdas, Tyrkiet (Türkiye), 59100
- Rekruttering
- Namik Kemal University Medical Faculty-Hematology ( Site 4912)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0090 282 250 50 50
-
-
İzmir
-
Bornova, İzmir, Tyrkiet (Türkiye), 35100
- Rekruttering
- Ege Universitesi Hastanesi ( Site 4902)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +905325566128
-
-
-
-
Baden-Wurttemberg
-
Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm. ( Site 2206)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +497315000
-
-
Rhineland-Palatinate
-
Trier, Rhineland-Palatinate, Tyskland, 54290
- Rekruttering
- Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +496519472571
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Rekruttering
- Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +49 341 97 13131
-
-
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
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 chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy
- Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only
- Relapsed or refractory to at least 1 prior available therapy
- Have at least 1 marker of disease burden
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization
- Has a life expectancy of at least 3 months
- Has the ability to swallow and retain oral medication
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening
- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria
- Participants with adequate organ function with specimens collected within 7 days before the start of study intervention
- If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception
- Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding
Exclusion Criteria:
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
- Has gastrointestinal (GI) dysfunction that may affect drug absorption
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL
- Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening
- Clinically significant cardiovascular disease
- Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients
- Has history of severe bleeding disorders (eg, hemophilia)
- Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization
- Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
- Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Nemtabrutinib + Venetoclax
Participants will receive nemtrabrutinib oral tablets at specified doses daily starting at Cycle 1 Day 1 (C1D1) and venetoclax oral tablets at doses of 20 mg up to 400 mg daily starting at Cycle 2 Day 1 (C2D1) up to 2 years post C2D1 or until progressive disease (PD) or discontinuation. A cycle = 4 weeks. |
5, 20, and 45 tablets
Andre navne:
10, 50, and 100 mg tablets
Andre navne:
|
|
Aktiv komparator: Venetoclax + Rituximab
Participants will receive venetoclax oral tablets at doses from 20 mg up to 400 mg daily starting at C1D1 on 4-week cycles up to 2 years and rituximab or biosimilar at 375 mg/m^2 up to 500 mg/m2 intravenous infusion once per 28-day cycle starting at C2D1, for 6 total cycles. Treatment will continue until progressive disease (PD) or discontinuation. |
10, 50, and 100 mg tablets
Andre navne:
100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Tidsramme: Up to approximately 12 Weeks
|
DLT evaluation period is defined as 8 weeks after the first dose of the combination treatment of nemtabrutinib plus venetoclax Cycle 2 Day 1 in Part 1 + 4 weeks follow up. Each cycle is 4 weeks. DLTs are: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting >7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib or venetoclax doses as a result of drug-related adverse events during the first 2 cycles; Grade 5 toxicity. |
Up to approximately 12 Weeks
|
|
Part 1: Number of Participants Experiencing Adverse Events (AEs)
Tidsramme: Up to approximately 28 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1. |
Up to approximately 28 months
|
|
Part 1: Number of Participants Discontinuing Study Treatment Due to AEs
Tidsramme: Up to approximately 25 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to AEs will be reported for Part 1. |
Up to approximately 25 months
|
|
Part 2: PFS per the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Blinded Independent Central Review (BICR)
Tidsramme: Up to approximately 71 months
|
PFS is defined as the time from randomization to the first documented disease progression per iwCLL criteria 2018 as accessed by BICR, or death due to any cause, whichever occurs first. PFS will be presented. |
Up to approximately 71 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 2: Undetectable Minimal Residual Disease (MRD) Rate in Bone Marrow as Assessed by Central Laboratory
Tidsramme: Up to approximately 46 months
|
Undetectable MRD, defined as <1 leukemic cell per 10,000 cells (MRD <10-4) in bone marrow. The MRD rate will be presented. |
Up to approximately 46 months
|
|
Part 2: Overall Survival (OS)
Tidsramme: Up to approximately 108 months
|
OS, defined as the time from randomization to death due to any cause. OS will be presented. |
Up to approximately 108 months
|
|
Part 2: Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
Tidsramme: Up to approximately 71 months
|
OR, defined as complete response/remission (CR), complete response with incomplete count recovery (CRi), nodular partial remission (nPR), or partial remission (PR). CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow. ORR will be presented. |
Up to approximately 71 months
|
|
Part 2: Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
Tidsramme: Up to approximately 108 months
|
DOR, defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow. DOR will be presented. |
Up to approximately 108 months
|
|
Part 2: Number of Participants Experiencing AEs
Tidsramme: Up to approximately 28 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2. |
Up to approximately 28 months
|
|
Part 2: Number of Participants Discontinuing Study Treatment Due to AEs
Tidsramme: Up to approximately 25 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to AEs will be reported for Part 2. |
Up to approximately 25 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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)
8. august 2023
Primær færdiggørelse (Anslået)
1. juni 2032
Studieafslutning (Anslået)
1. juli 2035
Datoer for studieregistrering
Først indsendt
7. juli 2023
Først indsendt, der opfyldte QC-kriterier
7. juli 2023
Først opslået (Faktiske)
17. juli 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. november 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
- ARQ531
Andre undersøgelses-id-numre
- 1026-010
- MK-1026-010 (Anden identifikator: MSD)
- BELLWAVE-010 (Anden identifikator: MSD)
- 2022-501560-17-00 (Registry Identifier: EU CT)
- U1111-1281-1520 (Registry Identifier: UTN)
- jRCT2061260028 (Registry Identifier: jRCT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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 .