A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

578

Participants

Timeline

Start Date

September 19, 2012

Primary Completion Date

January 23, 2019

Study Completion Date

January 23, 2019

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Ibrutinib

Type=exact number, unit=mg, number=420 , form=capsule, route=oral use. Capsule is taken once daily continuously.

DRUG

Bendamustine hydrochloride

Type=exact number, unit=mg, number=70 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Days 2-3 and Cycles 2-6, Days 1-2.

DRUG

Rituximab

Type=exact number, unit=mg, number=375 mg/m2 and 500 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Day 1, and Cycles 2-6, Day 1, respectively.

DRUG

Placebo

Form=capsule, route=oral use. Capsule is taken once daily continuously.

Trial Locations (155)

Unknown

Birmingham

Phoenix

Berkeley

Duarte

Greenbrae

Stamford

Washington D.C.

Boca Raton

Jacksonville

Atlanta

Marietta

Chicago

Springfield

Fort Wayne

Goshen

Indianapolis

Iowa City

Westwood

Louisville

Paducah

Marrero

Baltimore

Worcester

Ann Arbor

Battle Creek

Detroit

Lansing

St Louis

Lincoln

Lebanon

Hackensack

Albuquerque

Dunkirk

Hawthorne

New York

Bismarck

Cleveland

Portland

Charleston

Sioux Falls

Temple

Morgantown

Buenos Aires

Ciudad Autonoma Buenos Aires

Córdoba

Aalst

Bruges

Brussels

Ghent

Leuven

Rio de Janeiro

Salvador

São Paulo

Edmonton

Vancouver

Hamilton

London

Ottawa

Toronto

Montreal

Bogotá

Floridablanca

Brno

Prague

Créteil

Montpellier

Paris

Pessac

Pierre-Bénite

Tours

Villejuif

Aschaffenburg

Augsburg

Cologne

Dresden

Erlangen

Essen

Frankfurt

Frechen

Hamm

Heidelberg

Homburg/Saar

Kassel

Kiel

Koblenz

Kÿln N/a

Lebach

Magdeburg

Mannheim

Marburg

Mutlangen

Ulm

Würzburg

Athens

Thessalonikis

Haifa

Jerusalem

Nahariya

Netanya

Petah Tikva

Ramat Gan

Tel Aviv

México

Monterrey

Oaxaca City

Brzozów

Chorzów

Krakow

Opole

Słupsk

Coimbra

Lisbon

Ponta Delgada

Porto

Arkhangelsk

Dzerzhinsk

Krasnodar

Moscow

Nizhny Novgorod

Obninsk

Perm

Rostov-on-Don

Ryazan

Saint Petersburg

Samara

Sochi

Syktyvkar

Yekaterinburg

Seoul

Barcelona

L'Hospitalet de Llobregat

Madrid

Salamanca

Valencia

Gothenburg

Huddinge

Stockholm

Umeå

Ankara

Istanbul

Izmir

Kayseri

Cherkassy

Dnipro

Donetsk

Khakhiv

Khmelnitskiy

Kiev

Lviv

Vinnitsa

Birmingham

Harrow

Plymouth

Sheffield Yorks

Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY