Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

December 10, 2012

Primary Completion Date

June 5, 2015

Study Completion Date

December 15, 2016

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Ibrutinib

560 mg once daily continuous (without interruption) by mouth for 21-day cycles

DRUG

Temsirolimus

175 mg once daily intravenous infusion on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each 21-day cycle

Trial Locations (92)

Unknown

Antwerp

Bruges

Brussels

Edegem

Ghent

Leuven

Wilrijk

Goiânia

Porto Alegre

Ribeirão Preto

Rio de Janeiro

São Paulo

Edmonton

Ottawa

Montreal

Temuco

Bogotá

Medellín

Brno

Prague

Mulhouse

Paris

Pessac

Villejuif

Berlin

Cologne

Essen

Heidelberg

Homburg

Kiel

Mainz

München

Ulm

Budapest

Debrecen

Pécs

Szeged

Dublin

Monterrey

Oaxaca City

Querétaro

Amsterdam

Rotterdam

Brzozów

Chorzów

Gdansk

Krakow

Opole

Słupsk

Wroclaw

Coimbra

Lisbon

Porto

Chelyabinsk

Krasnodar

Moscow

Nizhny Novgorod

Obninsk

Rostov-on-Don

Saint Petersburg

Sochi

Syktyvkar

Yekaterinburg

Goyang-si

Seoul

Barcelona

Madrid

Palma de Mallorca

Salamanca

Valencia

Gothenburg

Lund

Stockholm

Umeå

Uppsala

Tainan City

Taipei

Taoyuan District

Cherkassy

Dnipro

Donetsk

Khmelnitskiy

Kiev

Lviv

Birmingham

Harrow

Leeds

Liverpool

London

Manchester

Plymouth

Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY