487
Participants
Start Date
May 1, 2008
Primary Completion Date
January 1, 2014
Study Completion Date
June 17, 2017
Rituximab 375 mg/m^2
Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.
Cyclophosphamide 750 mg/m^2
Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
Doxorubicin 50 mg/m^2
Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
VELCADE 1.3 mg/m^2
Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles
Prednisone 100 mg/m^2
Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles
Vincristine 1.4 mg/m^2
Intravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.
Sinai Hospital, Baltimore
Cancer Outreach Associates, PC, Abingdon
Division of Hematology and Oncology Vanderbilt University, Nashville
Center for Cancer Care at Goshen Hospital, Goshen
Legacy Pharma Research, Bismarck
Capitol Comp. Cancer Center, Jefferson City
Nebraska Cancer Specialists, Omaha
St. Francis Hosptial and Medical Center, Hartford
Hematology-Oncology Associates of Northern NJ, Morristown
St.Johanns Spital/Landeskrankenhaus Salzburg, Salzburg
Allgemeines Krankenhaus der Stadt Wien, Vienna
AZ Stuivenberg Oncologie/ Hematologie, Antwerp
AZ St Jan AV, Bruges
UZ Brussel Department Medical Oncology, Brussels
UZA Hematologie, 1e verdiep, Edegem
Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie, Ghent
UZ Leuven Gasthuisberg Hematologie, Leuven
C.H.R. Citadelle, Liège
Centre Hospitalier Universitaire, Liège
Ucl de Mont-Godinne, Yvoir
Centro de Hematologia E Hemoterapia - Unicamp, Campinas
Fundacao Hospital Amaral Carvalho, Jaú
Hospital Nossa Senhora da Conceicao, Porto Alegre
Hospital Sao Lucas Puc-Rs, Porto Alegre
Inca - Instituto Nacional Do Cancêr, Rio de Janeiro
Centro de Estudos de Hematologia E Oncologia Da Fmabc, São Paulo
Fundacao Pio XII - Hospital de Cancer de Barretos, São Paulo
Hospital Ac Camargo, São Paulo
Hospital Alemao Oswaldo Cruz, São Paulo
Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo
Santa Casa de Misericórida de São Paulo, São Paulo
Cross Cancer Institute, Edmonton
University Health Network, Princess Margaret Hospital, Toronto
Hospital Clinico Universidad Catolica de Chile, Santiago
Hospital Del Salvador, Santiago
Instituto Nacional Del Cancer, Santiago
Sun Yat-sen University Cancer Center, Guangzhou
West China Hospital, Sichuan University, Chengdu
Zhejiang University First Hospital, Hangzhou
Beijing Cancer Hospital, Beijing
Cancer Institute & Cancer Hospital, CAMS&PUMC, Beijing
Peking University Third Hospital, Beijing
Cancer hospital, Fudan University, Shanghai
Ruijin Hospital, Shanghai
Tianjin Medical University Cancer Hospital and Institute, Tianjin
Clinica Reina Sofia, Bogotá
Hospital Pablo Tobon Uribe, Medellín
Hospital Universitario San Vicente de Paul, Medellín
Interni hematoonkoligicka klinika, Brno
Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove, Hradec Králové
Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady, Prague
Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie, Berlin
Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie, Berlin
Städt. Kliniken Frankfurt-Hoechst Med. Klinik II - Hämatologie und Onkologie, Frankfurt
Tumorklinik SANAFONTIS Alpine GmbH, Freiburg im Breisgau
Wilhelm-Anton-Hospital Goch gGmbH Klinik für Hämatologie und internistische Onkologie, Goch
Klinikum Lippe-Lemgo Med. Klinik II - Hämatologie und Onkologie, Lemgo
Johannes-Gutenberg-Universität Mainz III. Med. Klinik, Mainz
Mutterhaus der Borromäerinnen Med. Klinik I, Trier
Schwarzwald-Baar-Kliniken Innere Med. II, Villingen
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika, Debrecen
Petz Aladár Kórház, II. Belgyógyászat, Győr
Kaposi Mor Megyei Korhaz, Belgyogyaszat, Kaposvár
Apollo Hospital and Research Foundation, Apollo Hospitals, Hyderabad 500033
Kidwai Memorial Institute of Oncology, Bangalore 560 029
Regional Cancer Centre, Medical Oncology, Thiruvananthapuram
Jehangir Hospital, Pune-411002
Sir Ganga Ram Hospital, New Delhi- 110060
Apollo Speciality Hospital, Chennai, Chennai-600035
Netaji Subash Chanda Bose Cancer Research Institute, Kolkata- 700016
Rambam Medical Center-Hematology department, Haifa
Hadassah Medical Center - Hematology department, Jerusalem
Rabin Medical Center, Beilinson Campus, Petach Tiqva
Sheba Medical Center, Ramat Gan
Kaplan Medical Center - Hematology Institute, Rehovot
"Azienda Ospedaliera Universitaria di Bologna Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche L. e A. Seragnoli", Bologna
Spedali Civili di Brescia, Brescia
Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia, Modena
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA DIPARTIMENTO DI MEDICINA U.O.C. Ematologia, Roma
"Azienda Ospedaliera San Giovanni Battista Molinette Struttura Complessa Ematologia 2", Torino
University Malaya Medical Centre, Kuala Lumpur
Gleneagles Medical Centre, Pulau Pinang
Hopital Du 20 Aout 1953, Casablanca
Centre D'oncologie Al Azhar, Rabat
Institut National D'oncologie, Rabat
National Kidney and Transplant Institute, Quezon City
St Lukes Medical Center, Quezon City
Szpital Morski im. PCK w Gdyni Gdynskie Centrum Onkologii Oddzial Chemioterapii, Gdynia
Klinika Hematologii Uniwersytetu Medycznego w Lodzi, Lodz
"Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego", Poznan
Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu, Wroclaw
Hospital Sao Marcos, Braga
Hospitais da Universidade de Coimbra, Coimbra
Hospital de Santa Maria, Lisbon
Instituto Portugues de Oncologia, Porto
"Spitalul Judetean de Urgenta Dr. Constantin Opris, Hematologie", Baia Mare
Institutul Clinic Fundeni, Hematologie, Bucharest
Spitalul Clinic Coltea, Clinica Hematologie, Bucharest
Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie, Bucharest
"Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Oncologie Medicala", Iași
Arkhangelsk Regional Clinical Hospital, Arkhangelsk
Belgorod Regional Oncology Center, Belgorod
Chelyabinsk Regional Oncology Center, Chelyabinsk
1st Republican Clinical Hospital of Udmurtia, Izhevsk
Cancer Research Center RAMS - N.N. Blokhin - Academy of Medical Science, Moscow
Hematology Scientific Center, Moscow
Moscow Regional Clinical Research Institute, Moscow
S.P. Botkin Moscow City Clinical Hospital, Moscow
Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod
Medical Scientific Radiology - Center, Obninsk
Omsk Regional Oncology Dispensary, Omsk
Medical Sanitary Unit # 1, Perm
Republikan Hospital named after V.A/ Baranov, Petrozavodsk
Rostov Research Institute of Oncology, Rostov-on-Don
Central Res. Inst. of Roentgen-Radiology, Saint Petersburg
City Clinical Oncology Dispensary, Saint Petersburg
Leningrad Region Clinical Hospital, Saint Petersburg
Pavlov State Medical Univercity, Saint Petersburg
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg
Sverdlovsk Regional Oncology Dispensary, Yekaterinburg
National Cancer Centre, Singapore
Singapore General Hospital - Hematology, Singapore
Chris Hani Baragwanath Hospital, Johannesburg
Medical Oncology Center of Rosebank, Johannesburg
University of the Witwatersrand Oncology, Johannesburg
Pretoria Academic Hospital-Dr. Savage Road, 3rd Floor Radiotherapy Building, Prinshof, Pretoria
Dr AI Pirjol & Dr WM Szpak Inc., Durban
Hospital Universitario Germans Trias i Pujol, Badalona
Hospital Clinic I Provincial de Barcelona, Barcelona
Hospital de la Princesa, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Clinico Universitario Salamanca, Salamanca
Chang Gung Memorial Hospital, Linkou, Taoyuan District
King Chulalongkorn Memorial Hospital, Bangkok
Ramathibodi Hospital, Bangkok
Siriraj Hospital-Hematology Unit, Bangkok
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine, Chiang Mai
Hôpital Farhat Hached, Sousse
Centre National de Greffe de Moelle osseuse, Tunis
Hôpital Aziza Othmana, Tunis
Institut Salah Azaiz, Tunis
Hacettepe University Medical Faculty, Ankara
Dokuz Eylul University Med. Fac., Izmir
Cherkassy Regional Oncology Center, Dept. of Hematology, Cherkassy
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center, Dnipro
Institute of Urgent and Recovery Surgery named after V.K.Gusaka of AMS of Ukraine, Haematology Dept., Donetsk
Khmelnitskiy Regional Hospital, Hematology Department, Khmelnitsky
National Cancer Institute, Department of chemotherapy of hemoblastosis, Kiev
Institute of Blood Pathology and Transfusion Medicine, Lviv Clinical Hospital #5, Hematology Dept., Lviv
Crimean Republic Clinical Oncology Dispensary, Haematology Department, Simferopol
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Millennium Pharmaceuticals, Inc.
INDUSTRY