A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

403

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

May 30, 2022

Study Completion Date

June 21, 2023

Conditions
Lymphoma
Interventions
DRUG

Bendamustine

90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.

DRUG

Rituximab

375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Cyclophosphamide

750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Doxorubicin

50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Vincristine

1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Prednisone

100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.

DRUG

PCI-32765 (Ibrutinib)

560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.

DRUG

Placebo

Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.

Trial Locations (135)

Unknown

Gilbert

Campbell

Duarte

La Jolla

Los Angeles

Orange

Ocala

Chicago

Maywood

Indianapolis

Westwood

Lexington

Lafayette

Scarborough

Baltimore

Bethesda

Boston

Ann Arbor

Battle Creek

Detroit

Saint Louis Park

Denville

New York

Hickory

Pinehurst

Bend

Pittsburgh

Sioux Falls

Houston

Lubbock

Spokane

Green Bay

Buenos Aires

Ciudad Autonoma Buenos Aires

Córdoba

La Capital

Mendoza

Santa Fe

Adelaide

Fitzroy

Heidelberg

South Brisbane

Wahroonga

Westmead

Anderlecht

Edegem

Ghent

Leuven

Namur

Wilrijk

Porto Alegre

Rio de Janeiro

Salvador

São Paulo

Beijing

Chengdu

Guangzhou

Hangzhou

Harbin

Nanjing

Shanghai

Tianjin

Nice

Paris

Pessac

Pierre-Bénite

Rennes

Berlin

Giessen

Göttingen

Ludwigshafen

Magdeburg

Mainz

München

Wiesbaden

Hadera

Haifa

Jerusalem

Nahariya

Netanya

Petah Tikva

Ramat Gan

Chūōku

Hiroshima

Isehara

Kobe

Nagoya

Osaka Sayama Shi

Sapporo

Sendai

Suita-shi

Tokyo

Gdynia

Olsztyn

Warsaw

Bayamón

Ponce

San Juan

Krasnodar

Moscow

Nizny Novgorod

Petrozavodsk

Pyatigorsk

Rostov-on-Don

Saint Petersburg

Syktyvkar

Volgograd

Jeollanam-do

Seoul

Barcelona

Madrid

Pozuelo de Alarcón

Salamanca

Gothenburg

Linköping

Luleå

Uppsala

Ankara

Antalya

Istanbul

Izmir

Kayseri

Cherkasy

Ivano-Frankivsk

Khmelnitskiy

Kiev

Lviv

Uzhhorod

Glasgow

London

Newcastle upon Tyne

Plymouth

Portsmouth

Sutton

Swansea

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT01974440 - A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter