- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112174
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Australian Capital Territory
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Canberra, Australian Capital Territory, Australia, 2605
- The Canberra Hospital
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New South Wales
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Albury, New South Wales, Australia, 2640
- Border Medical Oncology Research Unit
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Queensland
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Auchenflower, Queensland, Australia, 4101
- ICON Cancer Care
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer
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Melbourne, Victoria, Australia, 3065
- St.Vincent's Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Antwerpen, Belgium, 2060
- ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg
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Brugge, Belgium, 8000
- AZ Sint-Jan Brugge-Oostende AV
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Bruxelles, Belgium, 1000
- Institut Jules Bordet
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Yvoir, Belgium, 5530
- CHU UCL Namur asbl- Mont Godinne
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6G 1 Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer-Vancouver Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Queen Elizabeth II Health Science Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
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Quebec
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Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Brno, Czechia, 625 00
- FN Brno, Interni hematologicka a onkologicka klinika
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Hradec Králové, Czechia, 500 05
- Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika
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Olomouc, Czechia, 77900
- FN Olomouc
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Ostrava-Poruba, Czechia, 708 52
- FN Ostrava
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Praha 10, Czechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Czechia, 128 08
- Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie
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Bordeaux, France, 33076
- Institut Bergonie
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Clermont Ferrand cedex, France, 63003
- CHU Clermont Ferrand - Hôpital d'Estaing
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Marseille, France, 13009
- Institut Paoli Calmettes, Service Hematologie
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Nice Cedex 2, France, 06189
- Centre Antoine Lacassagne
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Paris, France, 75010
- Hopital Saint-Louis
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Pierre Benite cedex, France, 69495
- Centre Hospitalier Lyon Sud
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Tours Cedex 01, France, 37044
- CHU de Tours
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Calvados
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CAEN Cedex, Calvados, France, 14033
- CHU CAEN-Hôpital de la Côte de Nacre
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Berlin, Germany, 10967
- Vivantes Klinikum Am Urban
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Berlin, Germany, 12200
- Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin
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Essen, Germany, 45147
- Universitatsklinikum Essen, Klinik fur Hamatologie
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Homburg/Saar, Germany, 66421
- Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I
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Baden-Wuttemberg
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Mutlangen, Baden-Wuttemberg, Germany, 73557
- Kliniken Ostalb Stauferklinikum Schwab. Gmund
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Ulm, Baden-Wuttemberg, Germany, 89081
- Universitaetsklinikum Ulm
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Bayern
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Muenchen, Bayern, Germany, 81377
- Klinikum der Universitaet Muenchen Campus Grosshadern
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Koln
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Kerpen, Koln, Germany, 50937
- Universitatsklinikum Koln
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Mainz
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Langen, Mainz, Germany, 55131
- Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1
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Sachsen
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Dresden, Sachsen, Germany, 01307
- Gemeinschaftpraxis Haematologie und Onkologie
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Alexandroupolis, Greece, 68100
- University Hospital of Alexandroupolis
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Athens, Greece, 11527
- General Hospital of Athens Laiko
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Athens, Greece, 11528
- General Hospital of Athens "Alexandra"
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Athens, Greece, 11525
- 251 Air Force General Hospital
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Ioánnina, Greece, 45500
- University General Hospital of Ioannina
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Larissa, Greece, 41110
- University General Hospital of Larissa
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Patra, Greece, 26504
- University Hospital of Patras
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Budapest, Hungary, 1122
- Országos Onkológiai Intézet
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Budapest, Hungary, 1125
- Semmelweis Egyetem
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
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Győr, Hungary, 9024
- Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia
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Kaposvár, Hungary, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház
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Szeged, Hungary, 6725
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
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Szombathely, Hungary, 9700
- Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly
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Alessandria/Piemonte
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Alessandria, Alessandria/Piemonte, Italy, 15121
- Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
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Bergamo/Lombardia
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Bergamo, Bergamo/Lombardia, Italy, 21427
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna/Emilia-Romagna
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Bologna, Bologna/Emilia-Romagna, Italy, 40138
- Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi
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Brescia/Lombardia
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Brescia, Brescia/Lombardia, Italy, 25123
- Asst Degli Spedali Civili Di Brescia
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Cuneo/Piemonte
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Cuneo, Cuneo/Piemonte, Italy, 12100
- Azienda Ospedaliera S. Croce e Carle Cuneo
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Forli-Cesena/Emilia-Rom
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Meldola, Forli-Cesena/Emilia-Rom, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milano/Lombardia
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Milano, Milano/Lombardia, Italy, 20132
- IRCCS Ospedale S. Raffaele di Milano
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Milano, Milano/Lombardia, Italy, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Pavia/Lombardia
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Pavia, Pavia/Lombardia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Torino/Piemonte
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Torino, Torino/Piemonte, Italy, 10126
- Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino
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Udine/Friuli-Venezia Giulia
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Udine, Udine/Friuli-Venezia Giulia, Italy, 33010
- Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Groningen, Netherlands, 9713 GZ
- Universitair Medisch Centrum Groningen
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Hoofddorp, Netherlands, 2134 TM
- Spaarne Gasthuis
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Leiden, Netherlands, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Netherlands, 3015 CE
- Erasmus MC
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Schiedam, Netherlands, 3118 JH
- Franciscus Vlietland
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz
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Chorzów, Poland, 41-500
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny
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Kraków, Poland, 30-510Komisja Bioctyczn
- Malopolskie Centrum Medyczne s c
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Warszawa, Poland, 02-776
- Instytut Hematologii I Transfuzjologii
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Wrocław, Poland, 50-367
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ
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Łódź, Poland, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi
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Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Spain, 28040
- Fundación Jiménez Díaz
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Madrid, Spain, 28034
- Hospital Universitario Ramón y Cajal
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Asturias
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Gijón, Asturias, Spain, 33203
- Hospital Universitario de Cabueñes
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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L'Hospitalet De Llobregat, Barcelona, Spain, 08907
- ICO l'Hospitalet- Hospital Duran i Reynals
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
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Ankara, Turkey, 06500
- Gazi Universitesi Tip Fakultesi, Besevler
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Tekirdağ, Turkey, 59030
- Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi
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İzmir, Turkey
- Dokuz Eylul Universitesi Tip Fakultesi
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Samsun
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Kurupelit, Samsun, Turkey, 55139
- Ondokuz Mayiz universitesi Tip Fakultesi
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Cherkasy, Ukraine, 18009
- Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center
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Kharkiv, Ukraine, 61070
- Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology
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Kyiv, Ukraine, 03022
- 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
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Kyiv, Ukraine, 03115
- SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit
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Uzhgorod, Ukraine, 88018
- Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology
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Zhytomyr, Ukraine, 10002
- Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy
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London, United Kingdom, NW1 2PG
- University College London Hospitals NHS Foundation Trust
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Greater London
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London, Greater London, United Kingdom, EC1A 7BE
- Barts Health NHS Trust
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Nottingham university hospitals NHS trust
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7LE
- The Churchill Hospital
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS9 7TF
- St James University Hospital
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Arizona
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Tucson, Arizona, United States, 85719
- The University of Arizona Cancer Centre-North Campus
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California
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Duarte, California, United States, 91010
- City of Hope
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Los Angeles, California, United States, 90095
- UCLA Department of Medicine-Hematology/Oncology
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Florida
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Orlando, Florida, United States, 32806
- Orlando Health Inc.
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Kansas
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Westwood, Kansas, United States, 66205
- The University of Kansas Cancer Center and Medical Pavilion
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 11794
- Stony Brook University
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Tennessee Oncology
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98194
- Swedish Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Relapsed/Refractory Arm
Inclusion Criteria:
- Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
- At least 1 measurable site of disease on cross-sectional imaging (CT/PET).
- At least 1, but no more than 5, prior treatment regimens for MCL.
- Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
- Subjects must have adequate fresh or paraffin embedded tissue.
- Adequate hematologic, hepatic and renal function.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.
Exclusion Criteria:
- History or current evidence of central nervous system lymphoma.
- Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors.
- Prior treatment with venetoclax or other BCL2 inhibitors.
- Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents 21 days prior to receiving the first dose of study drug.
- Treatment with any of the following within 7 days prior to the first dose of study drug: moderate or strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers.
Treatment Naïve Arm
Inclusion Criteria:
- Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
- Men and women ≥18 years of age with a TP53 mutation.
- At least 1 measurable site of disease.
- Must have adequate fresh or paraffin-embedded tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
- Adequate hematologic, hepatic, and renal function.
Exclusion Criteria:
- Blastoid variant of MCL
- History or current evidence of CNS lymphoma.
- Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors.
- Prior treatment with venetoclax or other BCL2 inhibitors.
- Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
- Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug.
- Any uncontrolled active systemic infection.
- Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of HIV or active HCV or HBV.
- Major surgery within 4 weeks of the first dose of study drug.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk.
- Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
- Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers.
- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS.
- Chronic liver disease with hepatic impairment Child-Pugh class B or C.
- Unwilling or unable to participate in all required study evaluations and procedures.
- Known hypersensitivity to the active ingredient or other components of one or more study drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Safety Run-in Period
Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax. Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018. |
Administered orally once daily
Administered orally once daily
|
Experimental: Phase 3: Ibrutinb + Venetoclax
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
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Administered orally once daily
Administered orally once daily
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Placebo Comparator: Phase 3: Ibrutinib + Placebo
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
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Administered orally once daily
Administered orally once daily
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Experimental: Treatment-naive
This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL. Approximately 75 subjects (of which ~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax. |
Administered orally once daily
Administered orally once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Tumor Lysis Syndrome (TLS) (Safety Run-in Period)
Time Frame: Approximately 3 months after last subject enrolled into safety run-in portion
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To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
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Approximately 3 months after last subject enrolled into safety run-in portion
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Occurrence of Dose Limiting Toxicities (DLT) (Safety Run-in Period)
Time Frame: Approximately 3 months after last subject enrolled into safety run-in portion
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To evaluate the occurrence of DLTs with the concurrent administration of ibrutinib and venetoclax.
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Approximately 3 months after last subject enrolled into safety run-in portion
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Number of Participants With Adverse Events (AEs) (Safety Run-in Period)
Time Frame: Up to approximately 5 years
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
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Up to approximately 5 years
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Overall response rate (ORR) (Safety Run-in Period)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Duration of Response (DOR) (Safety Run-in Period)
Time Frame: Up to approximately 5 years
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DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
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Up to approximately 5 years
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Progression-free Survival (PFS) (Safety Run-in Period)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Overall Survival (OS) (Safety Run-in Period)
Time Frame: Up to approximately 5 years
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OS is defined as the time from the date of the first dose of study treatment to death from any cause.
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Up to approximately 5 years
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Progression-free Survival (PFS) (Randomization Period)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Complete Response (CR) (Treatment-Naive Arm)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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To evaluate the complete response (CR) rate with the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) (Randomization Period)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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approximately 1 year after last subject has stopped treatment with study drug(s)
|
Overall response rate (ORR) (Randomization Period and Treatment-Naive Arm)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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MRD-negative remission rate in participants who achieve CR per investigator assessment (Randomization Period and Treatment-Naive Arm)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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MRD-negative remission is defined as undetectable MRD at documented CR in subjects who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Overall Survival (OS) (Randomization Period and Treatment-Naive Arm)
Time Frame: Up to approximately 5 years
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OS is defined as the time from the date of the first dose of study treatment to death from any cause.
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Up to approximately 5 years
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Duration of Response (DOR) (Randomization Period and Treatment-Naive Arm)
Time Frame: Up to approximately 5 years
|
DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
|
Up to approximately 5 years
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Time to Next Treatment (TTNT) (Randomization Period and Treatment-Naive Arm)
Time Frame: Up to approximately 5 years
|
TTNT is defined as the duration from the date of randomization to the start date of any anti-lymphoma treatment subsequent to study treatment.
|
Up to approximately 5 years
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Percentage of participants experiencing Adverse Events (Randomization Period)
Time Frame: Up to approximately 5 years
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Up to approximately 5 years
|
Occurrence of Tumor Lysis Syndrome (TLS) (Randomization Period)
Time Frame: Approximately 3 months after last subject enrolled into safety run-in portion
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To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
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Approximately 3 months after last subject enrolled into safety run-in portion
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Cmax if Ibrutinib (Randomization Period)
Time Frame: Week 6
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Cmax if Ibrutinib.
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Week 6
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Tmax if Ibrutinib (Randomization Period)
Time Frame: Week 6
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Tmax if Ibrutinib.
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Week 6
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AUClast if Ibrutinib (Randomization Period)
Time Frame: Week 6
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AUClast if Ibrutinib.
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Week 6
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Half-Life (T1/2) if Ibrutinib (Randomization Period)
Time Frame: Week 6
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Half-Life (T1/2) if Ibrutinib.
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Week 6
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Cmax of Venetoclax (Randomization Period)
Time Frame: Week 6
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Cmax of Venetoclax.
|
Week 6
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Tmax of Venetoclax (Randomization Period)
Time Frame: Week 6
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Tmax of Venetoclax.
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Week 6
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AUC of Venetoclax (Randomization Period)
Time Frame: Week 6
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AUC of Venetoclax.
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Week 6
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Time to worsening in FACT-Lym subscale of the health-related quality of life (Randomization Period) questionnaire (FACT-Lym)
Time Frame: Week 6
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Time to worsening in FACT-Lym subscale of the health-related quality of life questionnaire (FACT-Lym) will be compared between treatment arms.
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Week 6
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Duration of CR (Treatment-Naive Arm Period)
Time Frame: Up to approximately 5 years
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Duration of CR, defined for subjects who achieve CR as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
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Up to approximately 5 years
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Progression-free Survival (PFS) (Treatment-Naive Arm Period)
Time Frame: approximately 1 year after last subject has stopped treatment with study drug(s)
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCYC-1143-CA
- 2017-000129-12 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mantle-Cell Lymphoma
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Northwestern UniversityNational Cancer Institute (NCI); Janssen Scientific Affairs, LLCActive, not recruitingStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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National Cancer Institute (NCI)CompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Stage I Mantle Cell Lymphoma | Stage II Contiguous Mantle Cell Lymphoma | Stage II Non-Contiguous Mantle Cell LymphomaUnited States
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University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma | Ann Arbor Stage I Mantle Cell Lymphoma | Ann Arbor Stage II Mantle Cell Lymphoma | Ann Arbor Stage III Mantle Cell Lymphoma | Ann Arbor Stage IV Mantle Cell LymphomaUnited States
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Burzynski Research InstituteWithdrawnRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell LymphomaUnited States
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BeiGeneRecruitingMantle Cell Lymphoma | Relapsed Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma (MCL)United States, China, Israel, Belgium, Poland, Spain, Turkey, Brazil, Italy, Canada, United Kingdom, France, Germany, Argentina
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BeiGeneCompletedRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMantle Cell Lymphoma | Blastoid Variant Mantle Cell Lymphoma | Pleomorphic Variant Mantle Cell LymphomaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Mantle Cell Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Refractory Mantle Cell Lymphoma | Central Nervous System Lymphoma | Gastric Mantle Cell Lymphoma | Splenic Mantle Cell LymphomaUnited States
Clinical Trials on Ibrutinib
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Christian BuskeAmgen; Janssen, LPRecruitingWaldenstrom MacroglobulinemiaAustria, Germany, Greece
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TG Therapeutics, Inc.CompletedMantle Cell Lymphoma | Chronic Lymphocytic LeukemiaUnited States
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Johnson & Johnson Private LimitedCompletedLymphoma, Mantle-Cell | Leukemia, Lymphocytic, Chronic, B-CellIndia
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Janssen Research & Development, LLCCompleted
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Janssen Research & Development, LLCCompleted
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Oncternal Therapeutics, IncUniversity of California, San Diego; Pharmacyclics LLC.; California Institute...Active, not recruitingMantle Cell Lymphoma | Marginal Zone Lymphoma | B-cell Chronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
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The Lymphoma Academic Research OrganisationJanssen Pharmaceutica N.V., BelgiumTerminatedB-cell LymphomaFrance, Belgium
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Pharmacyclics Switzerland GmbHJanssen Biotech, Inc., including Johnson & JohnsonEnrolling by invitationLymphoma, B-Cell | Lymphoma, Non-Hodgkin | Solid Tumor | Leukemia, B-cell | Graft Vs Host DiseaseUnited States, Spain, Taiwan, United Kingdom, Australia, Italy, Russian Federation, Canada, New Zealand, Korea, Republic of, France, Turkey, Czechia, Hungary, Poland, Sweden
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Janssen-Cilag Ltd.CompletedLymphoma, Mantle-Cell | Leukemia, Lymphocytic, Chronic, B-CellFrance
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The Lymphoma Academic Research OrganisationCompletedIntraocular Lymphoma | Primary Central Nervous LymphomaFrance