523
Participants
Start Date
May 16, 2013
Primary Completion Date
June 30, 2021
Study Completion Date
June 24, 2024
Bendamustine
90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
Rituximab
375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses
Ibrutinib
560 mg (4 x 140 mg capsules) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end
Placebo
4 capsules administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or the final analysis of progression-free survival
Tucson
Burbank
La Jolla
Stanford
Denver
New Haven
Stamford
Chicago
Maywood
Niles
Springfield
Goshen
Iowa City
Sioux City
Topeka
Westwood
Lexington
Louisville
Metairie
Ann Arbor
Detroit
Jefferson City
Lincoln
Hackensack
New Brunswick
Albuquerque
Albany
Hawthorne
New York
Durham
Greenville
Bismarck
Fargo
Eugene
Portland
Philadelphia
Greenville
Watertown
Nashville
Houston
San Antonio
Burlington
Spokane
Vancouver
Buenos Aires
Córdoba
La Capital
Paraná
Adelaide
Auchenflower
Box Hill
Concord
Douglas
Gosford
Hobart
Prahran
Antwerp
Bruges
Brussels
Ghent
Leuven
Wilrijk
Yvoir
Barretos
Goiânia
Porto Alegre
Ribeirão Preto
Rio de Janeiro
São Paulo
Edmonton
Vancouver
Hamilton
Ottawa
Montreal
Beijing
Chengdu
Guangzhou
Hangzhou
Shanghai
Tianjin
Brno
Hradec Králové
Prague
Créteil
F-75 730 Paris Cedex 15
Grenoble
Nantes
Paris
Pessac
Tours
Berlin
Heidelberg
Jena
Mainz
München
TÿBINGEN
Ulm
Villingen-Schwenningen
Athens
Athens Attica
Thessalonikis
Budapest
Debrecen
Kaposvár
Pécs
Szeged
Dublin
Galway
Afula
Beersheba
Haifa
Jerusalem
Nahariya
Petah Tikva
Ramat Gan
Tel Aviv
Ẕerifin
Fukuoka
Hiroshima
Kyoto
Nagoya
Osaka
Sapporo
Sendai
Suita
Tokyo
Monterrey
Oaxaca City
Amsterdam-Zuidoost
Dordrecht
Groningen
Leiden
Rotterdam
Utrecht
Bydgoszcz
Krakow
Olsztyn
Warsaw
Wroclaw
San Juan
Chelyabinsk
Krasnodar
Moscow
Nizhny Novgorod
Novosibirsk
Petrozavodsk
Rostov-on-Don
Ryazan
Saint Petersburg
Sochi
St.Petersurg
Syktyvkar
Volgograd
Yekaterinburg
Banská Bystrica
Bratislava
Košice
Martin
Prešov
Gyeonggi-do
Jeollanam-do
Seoul
Barcelona
Madrid
Oviedo
Palma de Mallorca
Salamanca
Santiago de Compostela
Linköping
Lund
Stockholm
Umeaa
Uppsala
Changhua
Kaohsiung County
Taichung
Tainan City
Taipei
Taoyuan District
Adana
Ankara
Diyarbakır
Istanbul
Izmir
Kayseri
Mersin
Cherkassy
Donetsk
Khmelnitskiy
Kiev
Lviv
Canterbury
Glasgow
Leeds
Leicester
Liverpool
London
Manchester
Plymouth
Southampton
Sutton
Collaborators (1)
Pharmacyclics LLC.
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY