Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT00312845
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 676
Subjects must satisfy the following criteria to be enrolled in the study:
- Man or woman and age 18 years or older
- Diagnosis of follicular B-NHL of the following subtypes (World Health Organization [WHO] classification 1997): follicular lymphoma (FL) (Grades 1 and 2).
- Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy.
If any prior regimen included rituximab, the subject must have responded (complete response [CR], unconfirmed complete response [CRu], partial response [PR]), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.
- At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation
- In the opinion of the investigator the decision to initiate treatment is justified to manage the subject's lymphoma
- No active central nervous system lymphoma
- Eastern Cooperative Oncology Group [ECOG] status ≤ 2
- Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for pharmacogenomics testing, but optional for serum protein testing and future testing.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
-
Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
-
Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.
-
History of disallowed therapies:
- Prior treatment with VELCADE
- Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- Nitrosoureas within 6 weeks before randomization
- Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- Stem cell transplant within 6 months before randomization
- Major surgery within 2 weeks before randomization
-
Residual toxic effects of previous therapy or surgery of Grade 3 or worse
-
Peripheral neuropathy or neuropathic pain of Grade 2 or worse
-
Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
-
History of allergic reaction attributable to compounds containing boron or mannitol
-
Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
-
Concurrent treatment with another investigational agent
-
Female subject who is pregnant or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bortezomib + Rituximab Bortezomib + Rituximab - Rituximab Rituximab -
- Primary Outcome Measures
Name Time Method Progression Free Survival Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Overall Response Rate Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.
Trial Locations
- Locations (206)
Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St. Jude Heritage Medical Group
🇺🇸Fullerton, California, United States
Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Central Hematology Oncology Medical Group, Inc
🇺🇸Alhambra, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Siouxland Hematolgoy-Oncology Associates
🇺🇸Sioux City, Iowa, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
University Health Network - Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Heilig Hart Roeselare
🇧🇪Roeselare, Belgium
Crimean Republic Clinical Oncology Dispensary
🇺🇦Simferopol, Ukraine
Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
🇺🇦Poltava, Ukraine
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Cancer Hospital (Institute), CAMS&PUMC
🇨🇳Beijing, China
Regional Cancer Centre
🇮🇳Kerala, India
Institutul Clinic Fundeni Clinica de Hematologie
🇷🇴Bucuresti, Romania
University of Southern California
🇺🇸Los Angeles, California, United States
Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
🇭🇺Debrecen, Hungary
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Satakunnan Keskussairaala
🇫🇮Pori, Finland
SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
🇭🇺Szeged, Hungary
Institution Manipal Hospital
🇮🇳Bangalore, India
Wojskowy Instytut Medyczny - Klinika Hematologii
🇵🇱Warsawa, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
🇵🇹Lisboa, Portugal
Petz Aladar County Hospital
🇭🇺Gyor, Hungary
Klinika Hematologii Instytut Chorob Wewnetrznych
🇵🇱Gdansk, Poland
Spitalul clinic de urgenta
🇷🇴Brasov, Romania
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
🇹🇭Chiang Mai, Thailand
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
South Texas Oncology and Hematology
🇺🇸San Antonio, Texas, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
Clinique Victor Hugo
🇫🇷Le Mans, France
Department of Medical Oncology - Regional Cancer Centre
🇮🇳Kerala, India
East Alabama Medical Center
🇺🇸Opelika,, Alabama, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸La Verne, California, United States
North Valley Hematology Oncology
🇺🇸Mission Hills, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Cancer Care Associates Medical Group, Inc.
🇺🇸Redondo Beach, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Norwalk Medical Group
🇺🇸Norwalk, Connecticut, United States
Hematology Oncology PC
🇺🇸Stamford, Connecticut, United States
Innovative Clinical Research of South Florida
🇺🇸Miami, Florida, United States
Hematology & Oncology Specialists
🇺🇸Metairie, Louisiana, United States
Hattiesburg Clinic
🇺🇸Hattesburg, Missouri, United States
Lancaster Cancer Center, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
The Western Pennsylvania Hospital
🇺🇸Pittsburg, Pennsylvania, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Institute J. Bordet
🇧🇪Bruxelles, Belgium
UZ Antwerpen - Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Clinique Notre Dame
🇧🇪Charleroi, Belgium
AZ Sint Jan
🇧🇪Brugge, Belgium
UZ Gent - Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Beijing Cancer Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Affiliated Hospital of the Academy of Military Medical Sciences
🇨🇳Beijing, China
Cancer Center, Sun Yat-Sen University
🇨🇳Guangzhou, China
Paijat - Hameen Keskussairaala
🇫🇮Lahti, Finland
Hopital Claude Huriez
🇫🇷Lille, France
Centre Léon Bérard
🇫🇷Lyon, France
Onkologische Schwerpunktpraxis
🇩🇪Herrsching, Germany
Nizam's Institute of Medical Sciences
🇮🇳Hyderabaad, India
Apollo Speciality Hospital
🇮🇳Chennai, India
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
SMS Medical College Hospital
🇮🇳Jaipur, India
Apollo Hospitals, Hyderabad Apollo Hospital Complex
🇮🇳Jubilee Hills, India
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Lung Cancer Center - National Cancer Center
🇰🇷Gyeonggi-Do, Korea, Republic of
Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
🇲🇽Delagacion Tlalpan, Mexico
Samsung Medical Center - Department of Internal Medicine
🇰🇷Ilwon dong, Kangnam-Ku, Seoul, Korea, Republic of
Klinika Hematologii - Uniwersytetu Medycznego
🇵🇱Lodz, Poland
Klinika Hematologii i Transplantologii Szpiku AM
🇵🇱Lublin, Poland
Instytut Hematologii i Transfuzjologii
🇵🇱Warszawa, Poland
Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
🇵🇱Wroclaw, Poland
Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE
🇵🇹Porto, Portugal
San Juan VA Medical Center
🇵🇷San Juan, Puerto Rico
City Oncology Hospital #62
🇷🇺Moscow, Russian Federation
Medical Scientifical Radiology Center
🇷🇺Obninsk, Russian Federation
Arkhangelsk Region Clinical Hospital
🇷🇺Arghangelsk, Russian Federation
Republikan Hospital named after V.A. Baranov
🇷🇺Petrozavodsk, Russian Federation
Spitalul Universitar de Urgenta Hematologie
🇷🇴Bucuresti, Romania
Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie
🇷🇴Iasi, Romania
Spitalul Clinic judetean de urgenta Mures
🇷🇴Targu Mures, Romania
Semashko Central Clinical Hospital #2
🇷🇺Moscow, Russian Federation
Altay Regional Oncology Dispensary
🇷🇺Barnaul, Russian Federation
Cancer Research Center
🇷🇺Moscow, Russian Federation
Cheliabinsk Regional Oncology Dispensary
🇷🇺Cheliabinsk, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
🇷🇺Moscow, Russian Federation
Moscow Region Clinical Research Institute
🇷🇺Moscow, Russian Federation
Belgorod Regional Oncology Center
🇷🇺Belgorod, Russian Federation
St. Petersburg City Hospital #31
🇷🇺St. Petersburg, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
🇷🇺Nizhniy Novgorod, Russian Federation
FN F.D. Roosevelt - Oddelenie hematologie
🇸🇰Banska Bysterica, Slovakia
East Cape Oncology Centre - St. Georges Hospital
🇿🇦Port Elizabeth, South Africa
Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
🇸🇰Kosice, Slovakia
Vychodoslovensky Onkologicky Ustave, a.s.
🇸🇰Kosice, Slovakia
Novosibirsk State Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Republican Clinical Hospital of Bashkorkostan
🇷🇺Ufa, Russian Federation
St. Petersburg Clinical Research Institute of Hematology and Transfusiology
🇷🇺St. Petersburg, Russian Federation
Saratov State Medical University
🇷🇺Saratov, Russian Federation
GVI Oncology Clinical Trial Unit
🇿🇦Panorama, Cape Town, South Africa
Martinska FN, Klinika hematologie a transfuziologie
🇸🇰Martin, Slovakia
Hospital Germans Trias i Pujol Institut Catala d'Oncologia
🇪🇸Barcelona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Onkologiska kliniken Universitetssjukhuset
🇸🇪Lund, Sweden
Centrum for Hematologi Karolinska University Hospital
🇸🇪Stockholm, Sweden
Hematologiska kliniken M54 Karolinska University Hospital
🇸🇪Stockholm, Sweden
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Ramathibodi Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Guy's & St. Thomas Hospital
🇬🇧London, United Kingdom
Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
🇺🇦Donetsk, Ukraine
Zhitomir Gerbachevsky Regional Clinical Hospital
🇺🇦Zhitomir, Ukraine
Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Cherkassy Regional Oncology Dispensary
🇺🇦Cherkassy, Ukraine
Khmelnitskiy Regional Hopsital
🇺🇦Khmelnitsky, Ukraine
Dnepropetrovsk Regional Clinical Oncology Dispensary
🇺🇦Dnepropetrovsk, Ukraine
Kiev Center of Marrow Transplantaion
🇺🇦Kiev, Ukraine
Krivoy Rog Oncology Dispensary
🇺🇦Krivoy Rog, Ukraine
Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
🇺🇦Lviv, Ukraine
Taunton & Somerset Hospital
🇬🇧Taunton, United Kingdom
Addenbrooke's Hospital - Department of Haematology
🇬🇧Cambridge, United Kingdom
Derriford Hospital - Department of Haematology
🇬🇧Plymouth, United Kingdom
Aberdeen Royal Infirmary - Department of Haematology
🇬🇧Aberdeen, United Kingdom
Medical College of Wisconsin Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Ekaterinburg City Clinical Hospital #7
🇷🇺Ekaterinburg, Russian Federation
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Saint Petersburg Pavlov State Medical University
🇷🇺Saint Petersburg, Russian Federation
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Northwest Georgia Oncology Centers, P.C.
🇺🇸Marietta, Georgia, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Suburban Hematology-Oncology Associates
🇺🇸Lawrenceville, Georgia, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Emory Univeersity ,Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Kansas City Cancer Center, LLC
🇺🇸Kansas City, Kansas, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
North Idaho Cancer Center
🇺🇸Coeur D Alene, Idaho, United States
Centro Oncologico Integracion Regional
🇦🇷Mendoza, Argentina
Higa San Martin
🇦🇷La Plata - Buenos Aires, Argentina
Hospital Professor Rodolfo Rossi
🇦🇷La Plata - Buenos Aires, Argentina
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
CHR La Citadelle
🇧🇪Liege, Belgium
ULB Erasme
🇧🇪Anderlecht, Belgium
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
AZ Stuivenberg
🇧🇪Antwerpen, Belgium
Virga Jesse Ziekenhuis, Dienst Hematologie
🇧🇪Hasselt, Belgium
CHU Sart Tilman
🇧🇪Liege, Belgium
Instituto Nacional de Cancer
🇧🇷Rio de Janeiro, Brazil
Faculdade de Medicina do ABC
🇧🇷Sao Paulo, Brazil
Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Hospital Brigadeiro
🇧🇷Sao Paulo, Brazil
West China Hospital of Sichuan
🇨🇳Chengdu, Sichuan, China
Juravinski Cancer Centre
🇨🇦Hamilton, Canada
Peking University Third Hospital
🇨🇳Haidian District Beijing, China
RuiJin Hospital
🇨🇳Shanghai, China
Cancer Hospital - FuDan University
🇨🇳Shanghai, China
Fakultni nemocnice Brno
🇨🇿Brno, Czech Republic
Bank of Cyprus Oncology Centre
🇨🇾Nikosia, Cyprus
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Institut Bergonie
🇫🇷Bordeaux, France
Vseobecna Fakultni Nemocnice
🇨🇿Praha, Czech Republic
Hopital Hotel Dieu
🇫🇷Nantes, France
Service des Maladies due sang - Hopital haut Leveque
🇫🇷Pessac, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
🇬🇷Athens, Greece
Praxis für Hämetologie und Oncologie
🇩🇪Würzburg, Germany
Universitatsklinikum Munster - Klinik fur Innere Medizin
🇩🇪Munster, Germany
University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
🇬🇷Athens, Greece
University Hospital of Patras - Department of Internal Medicine - Hematology Division
🇬🇷Rio Patras, Greece
Shirdi Saibaba Cancer Hospital
🇮🇳Karnataka, India
Rambam Medical Center
🇮🇱Haifa, Israel
Soroka Medical Center
🇮🇱Beer Sheva, Israel
Tata Memorial Centre
🇮🇳Mumbai, India
Azienda Ospedaliero Universitaria di Bologna
🇮🇹Bologna, Italy
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Sorraski Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Universita degli Studi di Perugia
🇮🇹Perugia, Italy
Azienda Ospedallera Universitaria Policlinico Tor Vergata
🇮🇹Roma, Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
🇮🇹Torino, Italy
Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
🇰🇷Ilmon-Dong, Kangnam-Ku, Seoul, Korea, Republic of
Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
🇰🇷Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
🇲🇽Monterrey, Nuevo leon, Mexico
Instituto Nacional De Cancerologia Incan
🇲🇽Delagacion Tlalpan, Mexico
Canterbury Health Laboratories
🇳🇿Christchurch, New Zealand
Klinika Hematologii CMUJ
🇵🇱Krakow, Poland
Klinika Hematologii AM
🇵🇱Warszawa, Poland
Klinika Nowotworow Ukladu Chlonnego
🇵🇱Warszawa, Poland
Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
🇵🇹Lisboa, Portugal
Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
1st Republican Clinical Hospital of Udmurtia
🇷🇺Izhevsk, Russian Federation
Tomsk Research Oncology Institute
🇷🇺Tomsk, Russian Federation
Chris Hani Baragwanath Hospital
🇿🇦Johannesburg, South Africa
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Mary Potter Oncology Centre - Little Company of Mary Hospital
🇿🇦Groenkloof, Pretoria, South Africa
Hospital Durans I Reynals - Institut Catala d'Oncologia
🇪🇸Barcelona, Spain
Louisville Oncology
🇺🇸Louisville, Kentucky, United States