323
Participants
Start Date
September 28, 2016
Primary Completion Date
November 12, 2020
Study Completion Date
March 27, 2024
ibrutinib
ibrutinib administered orally once daily (three 140 mg capsules)
venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.
Placebo
placebo capsules to match ibrutinib administered orally once daily
Middlemore Hospital /ID# 1142-0662, Otahuhu
St George Hospital /ID# 1142-0654, Kogarah
Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633, East Melbourne
St Vincent's Hospital Melbourne /ID# 1142-0501, Fitzroy
Austin Health /ID# 1142-0170, Heidelberg
Monash Medical Centre /ID# 1142-0556, Clayton
Frankston Hospital /ID# 1142-0715, Frankston
Palmerston North Hospital /ID# 1142-0585, Palmerston North
Flinders Medical Centre /ID# 1142-0163, Bedford Park
Christchurch Hospital /ID# 1142-0589, Christchurch
New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200, New York
Northwell Health/Long Island Jewish Hospital /ID# 1142-0350, New Hyde Park
Ospedale Policlinico San Martino /ID# 1142-0903, Genova
Hospital Universitario Virgen de las Nieves /ID# 1142-1196, Granada
University of Pennsylvania /ID# 1142-0069, Philadelphia
Ospedale San Raffaele IRCCS /ID# 1142-0523, Milan
ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581, Milan
Hospital Universitario Ramon y Cajal /ID# 1142-0874, Madrid
Hospital Universitario 12 de Octubre /ID# 1142-0864, Madrid
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1142-0582, Novara
Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733, Charlotte
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 1142-0536, Majadahonda
Azienda USL di Piacenza - Ospedale Guglielmo da Saliceto /ID# 1142-1182, Piacenza
Complejo Hospitalario de Navarra /ID# 1142-1197, Pamplona
Azienda Ospedaliera di Padova /ID# 1142-1175, Padua
Hospital Clinico Universitario de Salamanca /ID# 1142-0790, Salamanca
Norton Cancer Center /ID# 1142-0071, Louisville
Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524, Modena
Cleveland Clinic Foundation /ID# 1142-0739, Cleveland
MD Anderson Cancer Center /ID# 1142-0032, Houston
City of Hope /ID# 1142-0047, Duarte
Moores Cancer Center at UC San Diego /ID# 1142-0241, La Jolla
Swedish Cancer Institute /ID# 1142-0114, Seattle
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008, Orange
Rutgers Cancer Institute of New Jersey /ID# 1142-1193, New Brunswick
University of Rochester Cancer Center /ID# 1142-0127, Rochester
Tennessee Oncology - Chattanooga /ID# 1142-0123, Chattanooga
North Shore Hospital /ID# 1142-0663, Auckland
Malopolskie Centrum Medyczne /ID# 1142-0364, Krakow
Duplicate_Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 1142-0590, Lublin
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1142-0592, Brzozów
Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1142-0529, Gdansk
Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1142-0531, Lodz
Hospital Duran i Reynals /ID# 1142-0604, L'Hospitalet de Llobregat
Hospital Clinic de Barcelona /ID# 1142-0533, Barcelona
Hospital Santa Creu i Sant Pau /ID# 1142-0535, Barcelona
Lead Sponsor
Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY