Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

676

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

July 31, 2010

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Bortezomib + Rituximab

VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.

DRUG

Rituximab

rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).

Trial Locations (206)

2

Vseobecna Fakultni Nemocnice, Prague

1000

Institute J. Bordet, Brussels

1070

ULB Erasme, Anderlecht

2006

Bank of Cyprus Oncology Centre, Nicosia

2060

AZ Stuivenberg, Antwerp

2650

UZ Antwerpen - Universitair Ziekenhuis Antwerpen, Edegem

3002

Peter MacCallum Cancer Institute, East Melbourne

3004

Alfred Hospital, Melbourne

3050

Royal Melbourne Hospital, Parkville

3500

Virga Jesse Ziekenhuis, Dienst Hematologie, Hasselt

4000

CHR La Citadelle, Liège

CHU Sart Tilman, Liège

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

6000

Clinique Notre Dame, Charleroi

6160

Fremantle Hospital, Fremantle

8000

AZ Sint Jan, Bruges

8800

Heilig Hart Roeselare, Roeselare

9000

UZ Gent - Universitair Ziekenhuis Gent, Ghent

9024

Petz Aladar County Hospital, Győr

10002

Zhitomir Gerbachevsky Regional Clinical Hospital, Zhytomyr

10126

Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, Torino

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10700

Siriraj Hospital, Mahidol University, Bangkok

11527

Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department, Athens

12462

University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute, Athens

14000

Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran, Delagacion Tlalpan

14080

Instituto Nacional De Cancerologia Incan, Delagacion Tlalpan

15850

Paijat - Hameen Keskussairaala, Lahti

17601

Lancaster Cancer Center, Ltd., Lancaster

18009

Cherkassy Regional Oncology Dispensary, Cherkassy

26500

University Hospital of Patras - Department of Internal Medicine - Hematology Division, Rio Patras

27530

Southeastern Medical Oncology Center, Goldsboro

28046

Hospital Universitario La Paz, Madrid

28500

Satakunnan Keskussairaala, Pori

29000

Khmelnitskiy Regional Hopsital, Khmelnitsky

29210

South Carolina Oncology Associates, PA, Columbia

30045

Suburban Hematology-Oncology Associates, Lawrenceville

30060

Northwest Georgia Oncology Centers, P.C., Marietta

33076

Institut Bergonie, Bordeaux

33604

Service des Maladies due sang - Hopital haut Leveque, Pessac

36024

Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary, Poltava

37007

Hospital Universitario de Salamanca, Salamanca

37232

Vanderbilt University, Nashville

40138

Azienda Ospedaliero Universitaria di Bologna, Bologna

44098

Hopital Hotel Dieu, Nantes

46055

Dnepropetrovsk Regional Clinical Oncology Dispensary, Dnipro

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai

59037

Hopital Claude Huriez, Lille

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL, Monterrey, Nuevo Leon

66210

Kansas City Cancer Center, LLC, Kansas City

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72015

Clinique Victor Hugo, Le Mans

79044

Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5, Lviv

82211

Onkologische Schwerpunktpraxis, Herrsching am Ammersee

83045

Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine, Donetsk

90033

University of Southern California, Los Angeles

90095

University of California, Los Angeles, Los Angeles

90277

Cancer Care Associates Medical Group, Inc., Redondo Beach

90813

Pacific Shores Medical Group, Long Beach

91345

North Valley Hematology Oncology, Mission Hills

91505

Providence Saint Joseph Medical Center, Burbank

91790

Wilshire Oncology Medical Group, Inc., La Verne

91801

Central Hematology Oncology Medical Group, Inc, Alhambra

92835

St. Jude Heritage Medical Group, Fullerton

92868

University of California, Irvine Medical Center, Orange

93030

Ventura County Hematology-Oncology Specialists, Oxnard

93309

Comprehensive Blood and Cancer Center, Bakersfield

93454

Central Coast Medical Oncology Corporation, Santa Maria

97070

Praxis für Hämetologie und Oncologie, Würzburg

97517

FN F.D. Roosevelt - Oddelenie hematologie, Banska Bysterica

100021

Cancer Hospital (Institute), CAMS&PUMC, Beijing

100036

Beijing Cancer Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100071

Affiliated Hospital of the Academy of Military Medical Sciences, Beijing

100083

Peking University Third Hospital, Haidian District Beijing

115478

Cancer Research Center, Moscow

125101

S.P. Botkin Moscow City Clinical Hospital, Moscow

129110

Moscow Region Clinical Research Institute, Moscow

129128

Semashko Central Clinical Hospital #2, Moscow

143423

City Oncology Hospital #62, Moscow

163045

Arkhangelsk Region Clinical Hospital, Arghangelsk

185019

Republikan Hospital named after V.A. Baranov, Petrozavodsk

191024

St. Petersburg Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg

197022

Saint Petersburg Pavlov State Medical University, Saint Petersburg

197110

St. Petersburg City Hospital #31, Saint Petersburg

200025

RuiJin Hospital, Shanghai

200032

Cancer Hospital - FuDan University, Shanghai

249020

Medical Scientifical Radiology Center, Obninsk

308010

Belgorod Regional Oncology Center, Belgorod

410028

Saratov State Medical University, Saratov

426039

1st Republican Clinical Hospital of Udmurtia, Izhevsk

450005

Republican Clinical Hospital of Bashkorkostan, Ufa

454087

Cheliabinsk Regional Oncology Dispensary, Chelyabinsk

510060

Cancer Center, Sun Yat-Sen University, Guangzhou

603129

Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod

610041

West China Hospital of Sichuan, Chengdu

620137

Ekaterinburg City Clinical Hospital #7, Yekaterinburg

630087

Novosibirsk State Regional Clinical Hospital, Novosibirsk

630091

Novosibirsk State Medical University, Novosibirsk

634028

Tomsk Research Oncology Institute, Tomsk

656049

Altay Regional Oncology Dispensary, Barnaul

777024

Oncology Consultants, Houston

6000035

Apollo Speciality Hospital, Chennai

Unknown

East Alabama Medical Center, Opelika

Norwalk Medical Group, Norwalk

Hematology Oncology PC, Stamford

Integrated Community Oncology Network, Jacksonville

Innovative Clinical Research of South Florida, Miami

Palm Beach Cancer Institute, West Palm Beach

Emory Univeersity ,Winship Cancer Institute, Atlanta

North Idaho Cancer Center, Coeur d'Alene

Investigative Clinical Research of Indiana, Indianapolis

Siouxland Hematolgoy-Oncology Associates, Sioux City

Louisville Oncology, Louisville

Hematology & Oncology Specialists, Metairie

Sinai Hospital, Baltimore

Hattiesburg Clinic, Hattesburg

Oregon Health & Science University, Portland

The Western Pennsylvania Hospital, Pittsburgh

South Carolina Oncology Associates, Columbia

The Center for Cancer and Blood Disorders, Fort Worth

South Texas Oncology and Hematology, San Antonio

Medical College of Wisconsin Milwaukee, Milwaukee

Higa San Martin, La Plata - Buenos Aires

Hospital Professor Rodolfo Rossi, La Plata - Buenos Aires

Centro Oncologico Integracion Regional, Mendoza

Toronto Sunnybrook Regional Cancer Centre, Toronto

University Health Network - Princess Margaret Hospital, Toronto

Juravinski Cancer Centre, Hamilton

Universitatsklinikum Munster - Klinik fur Innere Medizin, Münster

Institution Manipal Hospital, Bangalore

Apollo Hospitals, Hyderabad Apollo Hospital Complex, Jubilee Hills

Department of Medical Oncology - Regional Cancer Centre, Kerala

Regional Cancer Centre, Kerala

Soroka Medical Center, Beersheba

Rambam Medical Center, Haifa

Hadassah Medical Center, Jerusalem

Rabin Medical Center, Petah Tikva

Sorraski Tel Aviv Medical Center, Tel Aviv

Sheba Medical Center, Tel Litwinsky

Canterbury Health Laboratories, Christchurch

Spitalul clinic de urgenta, Brasov

Institutul Clinic Fundeni Clinica de Hematologie, Bucharest

Spitalul Universitar de Urgenta Hematologie, Bucharest

"Spitalul Clinic judetean de urgenta Sf. Spiridon, Clinica Hematologie", Iași

Spitalul Clinic judetean de urgenta Mures, Târgu Mureş

GVI Oncology Clinical Trial Unit, Panorama

Chris Hani Baragwanath Hospital, Johannesburg

East Cape Oncology Centre - St. Georges Hospital, Port Elizabeth

Onkologiska kliniken Universitetssjukhuset, Lund

Centrum for Hematologi Karolinska University Hospital, Stockholm

Hematologiska kliniken M54 Karolinska University Hospital, Stockholm

Krivoy Rog Oncology Dispensary, Kryvyi Rih

Crimean Republic Clinical Oncology Dispensary, Simferopol

Aberdeen Royal Infirmary - Department of Haematology, Aberdeen

90610-00

Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul, Porto Alegre

20231-050

Instituto Nacional de Cancer, Rio de Janeiro

01404-901

Hospital Brigadeiro, São Paulo

09060-650

Faculdade de Medicina do ABC, São Paulo

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

775 20

Fakultni nemocnice Olomouc, Olomouc

H-4004

Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika, Debrecen

H-6720

SZEgedi Tudomanyegyetem, II Belgyaszati Klinika, Szeged

160 012

Postgraduate Institute of Medical Education and Research, Chandigarh

500 082

Nizam's Institute of Medical Sciences, Hyderabaad

302 004

SMS Medical College Hospital, Jaipur

576 104

Shirdi Saibaba Cancer Hospital, Karnataka

400 012

Tata Memorial Centre, Mumbai

06122

Universita degli Studi di Perugia, Perugia

00133

Azienda Ospedallera Universitaria Policlinico Tor Vergata, Roma

80-952

Klinika Hematologii Instytut Chorob Wewnetrznych, Gdansk

31-501

Klinika Hematologii CMUJ, Krakow

93-510

Klinika Hematologii - Uniwersytetu Medycznego, Lodz

20-081

Klinika Hematologii i Transplantologii Szpiku AM, Lublin

00-909

Wojskowy Instytut Medyczny - Klinika Hematologii, Warsaw

00-957

Instytut Hematologii i Transfuzjologii, Warsaw

02-097

Klinika Hematologii AM, Warsaw

02-781

Klinika Nowotworow Ukladu Chlonnego, Warsaw

50-367

Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku, Wroclaw

3000-075

Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia, Lisbon

1649-035

Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E., Lisbon

4200-072

Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE, Porto

00921

San Juan VA Medical Center, San Juan

040 11

Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie, Košice

041 90

Vychodoslovensky Onkologicky Ustave, a.s., Košice

036 59

Martinska FN, Klinika hematologie a transfuziologie, Martin

0181

Mary Potter Oncology Centre - Little Company of Mary Hospital, Groenkloof, Pretoria

411-769

Lung Cancer Center - National Cancer Center, Gyeonggi-do

135-710

Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine, Ilmon-Dong, Kangnam-Ku, Seoul

Samsung Medical Center - Department of Internal Medicine, Ilwon Dong, Kangnam-Ku, Seoul

410-769

Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center, Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do

120-752

Severance Hospital, Yonsei University College of Medicine, Seoul

138-736

Asan Medical Center, Seoul

08907

Hospital Durans I Reynals - Institut Catala d'Oncologia, Barcelona

08916

Hospital Germans Trias i Pujol Institut Catala d'Oncologia, Barcelona

03115

Kiev Center of Marrow Transplantaion, Kiev

CB2 2QQ

Addenbrooke's Hospital - Department of Haematology, Cambridge

CF14 4XN

University Hospital of Wales, Cardiff

SE1 9RT

Guy's & St. Thomas Hospital, London

PL6 8DH

Derriford Hospital - Department of Haematology, Plymouth

TA1 5DA

Taunton & Somerset Hospital, Taunton

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Millennium Pharmaceuticals, Inc.

INDUSTRY