Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

PHASE3CompletedINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

June 19, 2017

Primary Completion Date

June 26, 2024

Study Completion Date

June 27, 2024

Conditions
Mantle-Cell Lymphoma
Interventions
DRUG

Ibrutinib

Administered orally once daily

DRUG

Venetoclax

Administered orally once daily

DRUG

Placebo Oral tablet to match Venetoclax

Administered orally once daily

Trial Locations (120)

1000

Institut Jules Bordet, Brussels

1122

Orszagos Onkologiai Intezet, Budapest

1125

Semmelweis Egyetem, Budapest

2060

ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg, Antwerp

2605

The Canberra Hospital, Canberra

2640

Border Medical Oncology Research Unit, Albury

3000

Peter MacCallum Cancer, Melbourne

3065

St.Vincent's Hospital, Melbourne

3084

Austin Health, Heidelberg

4032

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Debrecen

4101

Icon Cancer Care, Auchenflower

5530

CHU UCL Namur asbl- Mont Godinne, Yvoir

6009

Sir Charles Gairdner Hospital, Nedlands

6725

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

8000

AZ Sint-Jan Brugge-Oostende AV, Bruges

9024

Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia, Győr

9700

Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly, Szombathely

10002

Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy, Zhytomyr

10065

Memorial Sloan Kettering Cancer Center, New York

10126

Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino, Torino

10967

Vivantes Klinikum Am Urban, Berlin

11525

251 Air Force General Hospital, Athens

11527

General Hospital of Athens Laiko, Athens

11528

"General Hospital of Athens Alexandra", Athens

11794

Stony Brook University, New York

12100

Azienda Ospedaliera S. Croce e Carle Cuneo, Cuneo

12200

Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin, Berlin

13009

Institut Paoli Calmettes, Service Hematologie, Marseille

14033

CHU CAEN-Hôpital de la Côte de Nacre, Caen

15121

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria

18009

Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center, Cherkasy

20132

IRCCS Ospedale S. Raffaele di Milano, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda, Milan

21427

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

21565

Gachon University Gil Medical Center, Incheon

25123

ASST degli Spedali Civili di Brescia, Brescia

26504

University Hospital of Patras, Pátrai

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28204

Levine Cancer Institute, Charlotte

31008

Clinica Universidad de Navarra, Pamplona

32806

Orlando Health Inc., Orlando

33010

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine

33076

Institut Bergonié, Bordeaux

33203

Hospital Universitario de Cabuenes, Gijón

37044

CHU de Tours, Tours

37404

Tennessee Oncology, Chattanooga

37920

University of Tennessee medical Center, Knoxville

40138

Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi, Bologna

40207

Norton Cancer Institute, Louisville

41110

University General Hospital of Larissa, Larissa

45147

Universitatsklinikum Essen, Klinik fur Hamatologie, Essen

45500

University General Hospital of Ioannina, Ioannina

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

48201

Barbara Ann Karmanos Cancer institute, Detroit

50937

Universitatsklinikum Koln, Kerpen

55131

Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1, Langen

55139

Ondokuz Mayiz universitesi Tip Fakultesi, Kurupelit

59030

Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi, Tekirdağ

61070

Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology, Kharkiv

63003

CHU Clermont Ferrand - Hôpital d'Estaing, Clermont-Ferrand

66205

The University of Kansas Cancer Center and Medical Pavilion, Westwood

66421

Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I, Homburg/Saar

68100

University Hospital of Alexandroupolis, Alexandroupoli

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

73557

Kliniken Ostalb Stauferklinikum Schwab. Gmund, Mutlangen

75010

Hôpital Saint-Louis, Paris

77030

University of Texas MD Anderson Cancer Center, Houston

77900

FN Olomouc, Olomouc

81377

Klinikum der Universitaet Muenchen Campus Grosshadern, Munich

85719

The University of Arizona Cancer Centre-North Campus, Tucson

88018

Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology, Uzhhorod

89081

Universitaetsklinikum Ulm, Ulm

90095

UCLA Department of Medicine-Hematology/Oncology, Los Angeles

91010

City of Hope, Duarte

98194

Swedish Cancer Institute, Seattle

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1 Z2

Cross Cancer Institute, Edmonton

V5Z 4E6

BC Cancer-Vancouver Centre, Vancouver

B3H 2Y9

Queen Elizabeth II Health Science Centre, Halifax

K1H 8L6

The Ottawa Hospital, Ottawa

H3T 1E2

Jewish General Hospital, Montreal

625 00

FN Brno, Interni hematologicka a onkologicka klinika, Brno

500 05

Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika, Hradec Králové

708 52

FN Ostrava, Ostrava-Poruba

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie, Prague

06189

Centre Antoine Lacassagne, Nice

01307

Gemeinschaftpraxis Haematologie und Onkologie, Dresden

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

2134 TM

Spaarne Gasthuis, Hoofddorp

2333 ZA

Leiden University Medical Center, Leiden

3015 CE

Erasmus MC, Rotterdam

3118 JH

Franciscus Vlietland, Schiedam

85-168

Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz, Bydgoszcz

41-500

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny, Chorzów

30-510Komisja Bioctyczn

Malopolskie Centrum Medyczne s c, Krakow

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi, Lodz

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ, Wroclaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08916

Hospital Universitari Germans Trias I Pujol, Badalona

08907

ICO l'Hospitalet- Hospital Duran i Reynals, L'Hospitalet de Llobregat

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

06500

Gazi Universitesi Tip Fakultesi, Besevler, Ankara

Unknown

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

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, Kyiv

03115

SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit, Kyiv

EC1A 7BE

Barts Health NHS Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

OX3 7LE

The Churchill Hospital, Oxford

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

LS9 7TF

St James University Hospital, Leeds

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY