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Brief Title: Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
Official Title: Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Study ID: NCT03112174
Brief Summary: This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Arizona Cancer Centre-North Campus, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
UCLA Department of Medicine-Hematology/Oncology, Los Angeles, California, United States
Orlando Health Inc., Orlando, Florida, United States
The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer institute, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
University of Tennessee medical Center, Knoxville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
The Canberra Hospital, Canberra, Australian Capital Territory, Australia
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Icon Cancer Care, Auchenflower, Queensland, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer, Melbourne, Victoria, Australia
St.Vincent's Hospital, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg, Antwerpen, , Belgium
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
CHU UCL Namur asbl- Mont Godinne, Yvoir, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer-Vancouver Centre, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
FN Brno, Interni hematologicka a onkologicka klinika, Brno, , Czechia
Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika, Hradec Králové, , Czechia
FN Olomouc, Olomouc, , Czechia
FN Ostrava, Ostrava-Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie, Praha 2, , Czechia
CHU CAEN-Hôpital de la Côte de Nacre, CAEN Cedex, Calvados, France
Institut Bergonié, Bordeaux, , France
CHU Clermont Ferrand - Hôpital d'Estaing, Clermont Ferrand cedex, , France
Institut Paoli Calmettes, Service Hematologie, Marseille, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Hôpital Saint-Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite cedex, , France
CHU de Tours, Tours Cedex 01, , France
Kliniken Ostalb Stauferklinikum Schwab. Gmund, Mutlangen, Baden-Wuttemberg, Germany
Universitaetsklinikum Ulm, Ulm, Baden-Wuttemberg, Germany
Klinikum der Universitaet Muenchen Campus Grosshadern, Muenchen, Bayern, Germany
Universitatsklinikum Koln, Kerpen, Koln, Germany
Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1, Langen, Mainz, Germany
Gemeinschaftpraxis Haematologie und Onkologie, Dresden, Sachsen, Germany
Vivantes Klinikum Am Urban, Berlin, , Germany
Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin, Berlin, , Germany
Universitatsklinikum Essen, Klinik fur Hamatologie, Essen, , Germany
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I, Homburg/Saar, , Germany
University Hospital of Alexandroupolis, Alexandroupolis, , Greece
251 Air Force General Hospital, Athens, , Greece
General Hospital of Athens Laiko, Athens, , Greece
General Hospital of Athens "Alexandra", Athens, , Greece
University General Hospital of Ioannina, Ioánnina, , Greece
University General Hospital of Larissa, Larissa, , Greece
University Hospital of Patras, Patra, , Greece
Orszagos Onkologiai Intezet, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia, Győr, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly, Szombathely, , Hungary
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria, Alessandria/Piemonte, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo, Bergamo/Lombardia, Italy
Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi, Bologna, Bologna/Emilia-Romagna, Italy
ASST degli Spedali Civili di Brescia, Brescia, Brescia/Lombardia, Italy
Azienda Ospedaliera S. Croce e Carle Cuneo, Cuneo, Cuneo/Piemonte, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Forli-Cesena/Emilia-Rom, Italy
IRCCS Ospedale S. Raffaele di Milano, Milano, Milano/Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, Milano/Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, Pavia/Lombardia, Italy
Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino, Torino, Torino/Piemonte, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine, Udine/Friuli-Venezia Giulia, Italy
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Franciscus Vlietland, Schiedam, , Netherlands
Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz, Bydgoszcz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny, Chorzów, , Poland
Malopolskie Centrum Medyczne s c, Kraków, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ, Wrocław, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi, Łódź, , Poland
Hospital Universitario de Cabuenes, Gijón, Asturias, Spain
Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain
ICO l'Hospitalet- Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Ondokuz Mayiz universitesi Tip Fakultesi, Kurupelit, Samsun, Turkey
Gazi Universitesi Tip Fakultesi, Besevler, Ankara, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, İzmir, , Turkey
Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi, Tekirdağ, , Turkey
Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center, Cherkasy, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology, Kharkiv, , Ukraine
National Inst. of Cancer, Scientific and Research Dept of Chemotherapy of Hemoblastosis and Adjuvant Treatment Methods, Dept of Oncohematology with Sector of Adjuvant treatment methods, Kyiv, , Ukraine
SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit, Kyiv, , Ukraine
Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology, Uzhgorod, , Ukraine
Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy, Zhytomyr, , Ukraine
Barts Health NHS Trust, London, Greater London, United Kingdom
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, United Kingdom
The Churchill Hospital, Oxford, Oxfordshire, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
St James University Hospital, Leeds, West Yorkshire, United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom