Spots Global Cancer Trial Database for A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
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Trial Identification
Brief Title: A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
Official Title: A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)
Study ID: NCT03053440
Conditions
Study Description
Brief Summary: This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
Detailed Description: This open-label, randomized study compared the efficacy and safety of the Bruton's Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in participants with Waldenström's Macroglobulinemia who require therapy. Participants had baseline bone marrow samples assayed for sequencing of the MYD88 gene. 201 participants with the MYD88 mutation were enrolled and randomized to receive 160 mg BGB-3111 orally twice per day (PO BID) (treatment Arm A) or to receive 420mg ibrutinib orally once per day (PO QD) (treatment Arm B) until disease progression or unacceptable toxicity.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
City Of Hope National Medical Center, Duarte, California, United States
University of California San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
Desert Hematology Oncology Medical Group Inc., Rancho Mirage, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachussetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Weill Cornell Medial College, New York, New York, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Woden Dermatology, Phillip, Australian Capital Territory, Australia
St George Hospital, Kogarah, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Peninsula Health, Frankston, Victoria, Australia
Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia
St. Vincent's Hospital, Melbourne, Victoria, Australia
Monash Medical Centre, Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan, Brugge, , Belgium
Fakultní nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Všeobecná fakultní nemocnice v Praze, Praha, , Czechia
CHU Clermont-Ferrand - CHU Estaing, Clermont, , France
Centre Leon Berard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Pitié Salpêtrière Hospital, Paris, , France
Universitätsklinik Freiburg, Freiburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Universitätsklinikum Münster Hämatologie und Onkologie, Munster, , Germany
SRH Kliniken Landkreis Sigmaringen GmbH, Sigmaringen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
General Hospital of Athens "Alexandra", Athens, Attiki, Greece
Sant'Orsola-Malpighi Polyclinic, Bologna, , Italy
Azienda Ospedaliera Spedali Civili Di Brescia, Brescia, , Italy
PO A.Ferrarotto, AOU Policlinico-Vittorio Emanuele Catania, Catania, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Irccs Irst, Meldola, , Italy
Niguarda Cancer Center Division of Hematology, Milan, , Italy
Azienda Ospedaliera "Maggiore della Carità" di Novara, Novara, , Italy
Università degli studi di Pavia, Pavia, , Italy
Ospedale Civile S.Maria delle, Ravenna, , Italy
Università degli Studi di Roma "La Sapienza", Rome, , Italy
PU A. Gemelli, Universität Cattolica del Sacro Cuore, Rome, , Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, , Italy
Azienda-Ospedaliera Udine, Udine, , Italy
Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Uniwersytecki Szpital Kliniczny w Białymstoku, Białystok, , Poland
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologiczny, Brzozów, , Poland
Szpital Uniwersytecki nr 2, Bydgoszcz, , Poland
SPZOZ - Zespół Szpitali Miejskich, Chorzów, , Poland
Szpitale Pomorskie Sp. z o.o., Szpital Morski im. PCK Gdansk, Gdynia, , Poland
Małopolskie Centrum Medyczne, Krakow, , Poland
Szpital Wojewodzki w Opolu Sp. z o.o., Opole, , Poland
Instytut Hematologii i Transfuzjologii w Warszawie, Warsaw, , Poland
H.U. Vall d´Herbon, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Duran i Reynals, Instituto Catalán de Oncología, Barcelona, , Spain
Germans Trias i Pujol University Hospital, Barcelona, , Spain
Hospital de Sant Pau, Barcelona, , Spain
ICO-H.U.G. Trias i Pujol, Barcelona, , Spain
Hospital Universitario A Coruña, La Coruña, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Clinica Universidad de Navarra, Navarro, , Spain
Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hematology Center Karolinska, Stockholm, , Sweden
The Royal Bournemouth and Christchurch Hospitals NHS Foundation, Bournemouth, , United Kingdom
Churchill Hospital, Headington, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
St.Bartholomew's Hospital, London, , United Kingdom
University College Hospital, London, , United Kingdom
Royal Gwent Hospital, Newport, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Contact Details
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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