A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

PHASE3CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

October 6, 2014

Primary Completion Date

March 26, 2018

Study Completion Date

September 3, 2019

Conditions
Chronic Lymphocytic LeukemiaSmall-Cell Lymphoma
Interventions
DRUG

Ibrutinib

Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.

DRUG

Obinutuzumab

Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration

DRUG

Chlorambucil

Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration

Trial Locations (71)

Unknown

Site Reference ID/Investigator# 0241, La Jolla

Site Reference ID/Investigator# 0844, Fort Myers

Site Reference ID/Investigator# 0763, West Palm Beach

Site Reference ID/Investigator# 071, Louisville

Site Reference ID/Investigator# 0712, Las Vegas

Site Reference ID/Investigator# 0845, Cincinnati

Site Reference ID/Investigator# 0868, Chattanooga

Site Reference ID/Investigator# 0123, Nashville

Site Reference ID/Investigator #0503, Woolloongabba

Site Reference ID/Investigator# 0650, Adelaide

Site Reference ID/Investigator# 0888, Ballarat

Site Reference ID/Investigator# 0193, Box Hill

Site Reference ID/Investigator# 0633, Fitzroy

Site Reference ID/Investigator# 0170, Heidelberg

Site Reference ID/Investigator# 0352, Linz

Site Reference ID/Investigator# 0869, Salzburg

Site Reference ID/Investigator# 0559, Leuven

Site Reference ID/Investigator# 0850, Turnhout

Site Reference ID/Investigator# 018, Edmonton

Site Reference ID/Investigator# 0564, Hradec Králové

Site Reference ID/Investigator# 0854, Prague

Site Reference ID/Investigator# 0769, Pessac

Site Reference ID/Investigator# 0520, Nantes

Site Reference ID/Investigator# 0775, Vandœuvre-lès-Nancy

Site Reference ID/Investigator# 0855, Bayonne

Site Reference ID/Investigator# 0573, Haifa

Site Reference ID/Investigator# 0577, Jerusalem

Site Reference ID/Investigator# 0579, Jerusalem

Site Reference ID/Investigator# 0575, Petah Tikva

Site Reference ID/Investigator# 0856, Tel Aviv

Site Reference ID/Investigator# 0875, Ẕerifin

Site Reference ID/Investigator# 0860, Florence

Site Reference ID/Investigator# 0523, Milan

Site Reference ID/Investigator# 0581, Milan

Site Reference ID/Investigator# 0584, Milan

Site Reference ID/Investigator# 0524, Modena

Site Reference ID/Investigator# 0582, Novara

Site Reference ID/Investigator# 0732, Roma

Site Reference ID/Investigator# 0859, Siena

Site Reference ID/Investigator# 0663, Auckland

Site Reference ID/Investigator# 662, Auckland

Site Reference ID/Investigator# 0586, Hamilton

Site Reference ID/Investigator# 0592, Brzozów

Site Reference ID/Investigator# 0531, Lodz

Site Reference ID/Investigator# 0708, Nizhny Novgorod

Site Reference ID/Investigator# 0707, Ryazan

Site Reference ID/Investigator# 0881, Saint Petersburg

Site Reference ID/Investigator# 710, Saint Petersburg

Site Reference ID/Investigator# 304, Yaroslavl

Site Reference ID/Investigator# 0604, L'Hospitalet de Llobregat

Site Reference ID/Investigator# 0536, Majadahonda

Site Reference ID/Investigator# 0533, Barcelona

Site Reference ID/Investigator# 0534, Barcelona

Site Reference ID/Investigator# 0535, Barcelona

Site Reference ID/Investigator# 0537, Madrid

Site Reference ID/Investigator# 0864, Madrid

Site Reference ID/Investigator# 0874, Madrid

Site Reference ID/Investigator# 0790, Salamanca

Site Reference ID/Investigator# 0870, Borås

Site Reference ID/Investigator# 0865, Luleå

Site Reference ID/Investigator# 0631, Lund

Site Reference ID/Investigator# 0632, Stockholm

Site Reference ID/Investigator# 0678, Istanbul

Site Reference ID/Investigator# 0608, Ankara

Site Reference ID/Investigator# 606, Ankara

Site Reference ID/Investigator# 0889, Denizli

Site Reference ID/Investigator# 0601, Izmir

Site Reference ID/Investigator# 0866, Samsun

Site Reference ID/Investigator# 0867, Harlow

Site Reference ID/Investigator# 0365, London

Site Reference ID/Investigator# 0543, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY