A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

838

Participants

Timeline

Start Date

September 3, 2013

Primary Completion Date

February 26, 2018

Study Completion Date

April 5, 2019

Conditions
Lymphoma
Interventions
DRUG

Ibrutinib

560 mg capsules administered by mouth once daily (21-day cycles)

DRUG

Placebo

4 matched capsules administered by mouth once daily (21-day cycles)

DRUG

Rituximab

375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Cyclophosphamide

750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Doxorubicin

50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Vincristine

1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Prednisone (or equivalent)

100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Trial Locations (201)

Unknown

Tucson

Greenbrae

La Jolla

Los Angeles

Salinas

Stanford

Danbury

Hartford

Washington D.C.

Atlanta

Marietta

Peoria

Fort Wayne

Goshen

Indianapolis

Topeka

Louisville

Baton Rouge

New Orleans

Baltimore

Bethesda

Boston

Ann Arbor

St Louis

Omaha

Hackensack

New Brunswick

Fresh Meadows

Johnson City

Mineola

New York

Rochester

The Bronx

Charlotte

Greenville

Hickory

Columbus

Portland

North Charleston

Nashville

Houston

Temple

Burlington

Seattle

Buenos Aires

Ciudad de Buenos Aires

Adelaide

Concord

Darlinghurst

Hobart

Melbourne

Nedlands

Perth

Randwick

South Brisbane

Woolloongabba

Antwerp

Bruges

Brussels

Ghent

Haine Saint Paul La Louviere

Kortrijk

Leuven

Porto Alegre

Rio de Janeiro

São Paulo

Edmonton

Vancouver

Halifax

Toronto

Lévis

Montreal

Beijing

Changchun

Chengdu

Guangzhou

Hangzhou

Harbin

Jinan

Nanjing

Shanghai

Tianjin

Brno

Hradec Králové

Ostrava

Prague

Aarhus N

Copenhagen

Roskilde

Vejle

Helsinki

Jyväskylä

Oulu

Turku

Grenoble

Limoges

Paris

Pessac

Pierre-Bénite

Rouen

Tours

Villejuif

Augsburg

Bamberg

Berlin

Dresden

Essen

Frankfurt

Jena

München

Münster

Villingen-Schwenningen

Budapest

Debrecen

Gyula

Szombathely

Veszprém

Beersheba

Hadera

Haifa

Petah Tikva

Ramat Gan

Tel Aviv

Fukuoka

Hiroshima

Isehara

Kobe

Kumamoto

Kyoto

Nagano

Nagoya

Narita

Osaka

Ōsaka-sayama

Sapporo

Sendai

Suita

Tachikawa

Tokyo

Tsukuba

México

Monterrey

San Luis Potosí City

Amsterdam-Zuidoost

Arnhem

Dordrecht

Groningen

Leiden

Nieuwegein

Rotterdam

Oslo

Tromsø

Brzozów

Chorzów

Krakow

Lodz

Olsztyn

Poznan

Warsaw

Wroclaw

Moscow

Nizhny Novgorod

Rostov-on-Don

Saint Petersburg

Sochi

Volgograd

Yekaterinburg

Busan

Goyang-si

Seoul

Barcelona

Madrid

Salamanca

Seville

Linköping

Luleå

Lund

Uppsala

Taichung

Tainan City

Taoyuan

Adana

Ankara

Istanbul

Izmir

Kayseri

Samsun

Cherkassy

Khmelnitskiy

Kiev

Lviv

Makiivka

Glasgow

Liverpool

London

Maidstone

Manchester

Nottingham

Oxford

Romford

Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY