269
Participants
Start Date
March 31, 2013
Primary Completion Date
May 31, 2015
Study Completion Date
May 31, 2015
Ibrutinib
Ibrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit.
Chlorambucil
Chlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle. The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.
Site Reference ID/Investigator #572, Dublin
Site Reference ID/Investigator #570, Dublin
Site Reference ID/Investigator #591, Chorzów
Site Reference ID/Investigator #184, Brussells
Site Reference ID/Investigator #588, Auckland
Site Reference ID/Investigator #164, Brussels
Site Reference ID/Investigator #561, Antwerp
Site Reference ID/Investigator #654, Kogarah
Site Reference ID/Investigator #559, Leuven
Site Reference ID/Investigator #501, Fitzroy
Site Reference ID/Investigator #170, Heidelberg
Site Reference ID/Investigator #193, Box Hill
Site Reference ID/Investigator #556, Clayton
Site Reference ID/Investigator #715, Frankston
Site Reference ID/Investigator #558, Geelong
Site Reference ID/Investigator #586, Hamilton
Site Reference ID/Investigator #503, Woolloongabba
Site Reference ID/Investigator #163, Bedford Park
Site Reference ID/Investigator #727, Yvoir
Site Reference ID/Investigator #587, Wellington
Site Reference ID/Investigator #555, Hobart
Site Reference ID/Investigator #628, Bruges
Site Reference ID/Investigator #589, Christchurch
Site Reference ID/Investigator #560, Ghent
Site Reference ID/Investigator #724, Zhytomyr
Site Reference ID/Investigator #350, New Hyde Park
Site Reference ID/Investigator #127, Rochester
Site Reference ID/Investigator #050, Pittsburgh
Site Reference ID/Investigator #597, Cherkasy
Site Reference ID/Investigator #522, Rozzano
Site Reference ID/Investigator #584, Milan
Site Reference ID/Investigator #523, Milan
Site Reference ID/Investigator #581, Milan
Site Reference ID/Investigator #595, Vinnytsia
Site Reference ID/Investigator #578, Nahariya
Site Reference ID/Investigator #656, Goldsboro
Site Reference ID/Investigator #537, Madrid
Site Reference ID/Investigator #582, Novara
Site Reference ID/Investigator #536, Majadahonda
Site Reference ID/Investigator #125, Atlanta
Site Reference ID/Investigator #675, Hangzhou
Site Reference ID/Investigator #573, Haifa
Site Reference ID/Investigator #576, Haifa
Site Reference ID/Investigator #599, Istanbul
Site Reference ID/Investigator #714, Izmir
Site Reference ID/Investigator #527, Padua
Site Reference ID/Investigator #601, Izmir
Site Reference ID/Investigator #602, Kayseri
Site Reference ID/Investigator #580, Bologna
Site Reference ID/Investigator #071, Louisville
Site Reference ID/Investigator #524, Modena
Site Reference ID/Investigator #734, Columbus
Site Reference ID/Investigator #387, Ann Arbor
Site Reference ID/Investigator #575, Petah Tikva
Site Reference ID/Investigator #594, Dnipropetrovsk
Site Reference ID/Investigator #574, Ramat Gan
Site Reference ID/Investigator #126, Chicago
Site Reference ID/Investigator #725, Kharkiv
Site Reference ID/Investigator #221, St Louis
Site Reference ID/Investigator #032, Houston
Site Reference ID/Investigator #381, Laredo
Site Reference ID/Investigator #653, San Antonio
Site Reference ID/Investigator #596, Lviv
Site Reference ID/Investigator #712, Las Vegas
Site Reference ID/Investigator #047, Duarte
Site Reference ID/Investigator #577, Jerusalem
Site Reference ID/Investigator #408, La Jolla
Site Reference ID/Investigator #038, Stanford
Site Reference ID/Investigator #598, Simferopol
Site Reference ID/Investigator #720, Santa Rosa
Site Reference ID/Investigator #677, Portland
Site Reference ID/Investigator #404, Seattle
Site Reference ID/Investigator #731, Walla Walla
Site Reference ID/Investigator #670, Beijing
Site Reference ID/Investigator #673, Beijing
Site Reference ID/Investigator #304, Yaroslavl
Site Reference ID/Investigator #671, Nanjing
Site Reference ID/Investigator #707, Ryazan
Site Reference ID/Investigator #674, Guangzhou
Site Reference ID/Investigator #307, Worcester
Site Reference ID/Investigator #157, Calgary
Site Reference ID/Investigator #018, Edmonton
Site Reference ID/Investigator #159, Ottawa
Site Reference ID/Investigator #564, Hradec Králové
Site Reference ID/Investigator #562, Brno
Site Reference ID/Investigator #566, Plzen-Lochotin
Site Reference ID/Investigator #571, Galway
Site Reference ID/Investigator #583, Rome
Site Reference ID/Investigator #663, Auckland
Site Reference ID/Investigator #590, Lublin
Site Reference ID/Investigator #592, Brzozowie
Site Reference ID/Investigator #529, Gdansk
Site Reference ID/Investigator #531, Lodz
Site Reference ID/Investigator #534, Barcelona
Site Reference ID/Investigator #533, Barcelona
Site Reference ID/Investigator #535, Barcelona
Site Reference ID/Investigator #604, Barcelona
Site Reference ID/Investigator #608, Ankara
Site Reference ID/Investigator #606, Ankara
Site Reference ID/Investigator #551, Bournemouth
Site Reference ID/Investigator #544, London
Site Reference ID/Investigator #668, Oxford
Site Reference ID/Investigator #549, Colchester
Site Reference ID/Investigator #607, Cardiff
Site Reference ID/Investigator #550, Leeds
Site Reference ID/Investigator #721, Birmingham
Site Reference ID/Investigator #548, Nottingham
Site Reference ID/Investigator #367, Southampton
Lead Sponsor
Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY