Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma
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.
Status | Completed |
Enrollment | 676 |
Est. completion date | July 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 (ß-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. Exclusion Criteria: 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Higa San Martin | La Plata - Buenos Aires | |
Argentina | Hospital Professor Rodolfo Rossi | La Plata - Buenos Aires | |
Argentina | Centro Oncologico Integracion Regional | Mendoza | |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Peter MacCallum Cancer Institute | East Melbourne | Victoria |
Australia | Fremantle Hospital | Fremantle | Western Australia |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Belgium | ULB Erasme | Anderlecht | |
Belgium | AZ Stuivenberg | Antwerpen | |
Belgium | AZ Sint Jan | Brugge | |
Belgium | Institute J. Bordet | Bruxelles | |
Belgium | Clinique Notre Dame | Charleroi | |
Belgium | UZ Antwerpen - Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | UZ Gent - Universitair Ziekenhuis Gent | Gent | |
Belgium | Virga Jesse Ziekenhuis, Dienst Hematologie | Hasselt | |
Belgium | CHR La Citadelle | Liege | |
Belgium | CHU Sart Tilman | Liege | |
Belgium | Heilig Hart Roeselare | Roeselare | |
Brazil | Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul | Porto Alegre | Rio Grande do Sul |
Brazil | Instituto Nacional de Cancer | Rio de Janeiro | |
Brazil | Faculdade de Medicina do ABC | Sao Paulo | |
Brazil | Hospital Brigadeiro | Sao Paulo | |
Canada | Juravinski Cancer Centre | Hamilton | |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Canada | University Health Network - Princess Margaret Hospital | Toronto | Ontario |
China | Affiliated Hospital of the Academy of Military Medical Sciences | Beijing | |
China | Beijing Cancer Hospital | Beijing | |
China | Cancer Hospital (Institute), CAMS&PUMC | Beijing | |
China | Peking University People's Hospital | Beijing | |
China | West China Hospital of Sichuan | Chengdu | Sichuan |
China | Cancer Center, Sun Yat-Sen University | Guangzhou | |
China | Peking University Third Hospital | Haidian District Beijing | |
China | Cancer Hospital - FuDan University | Shanghai | |
China | RuiJin Hospital | Shanghai | |
Cyprus | Bank of Cyprus Oncology Centre | Nikosia | |
Czech Republic | Fakultni nemocnice Brno | Brno | |
Czech Republic | Fakultni nemocnice Hradec Kralove | Hradec Kralove | |
Czech Republic | Fakultni nemocnice Olomouc | Olomouc | |
Czech Republic | Vseobecna Fakultni Nemocnice | Praha | |
Finland | Paijat - Hameen Keskussairaala | Lahti | |
Finland | Satakunnan Keskussairaala | Pori | |
France | Institut Bergonie | Bordeaux | |
France | Clinique Victor Hugo | Le Mans | |
France | Hopital Claude Huriez | Lille | |
France | Centre Léon Bérard | Lyon | |
France | Hopital Hotel Dieu | Nantes | |
France | Service des Maladies due sang - Hopital haut Leveque | Pessac | |
France | Centre Hospitalier Lyon Sud | Pierre Benite | |
Germany | Onkologische Schwerpunktpraxis | Herrsching | |
Germany | Universitatsklinikum Munster - Klinik fur Innere Medizin | Munster | |
Germany | Praxis für Hämetologie und Oncologie | Würzburg | |
Greece | Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department | Athens | |
Greece | 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 | |
Hungary | Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika | Debrecen | |
Hungary | Petz Aladar County Hospital | Gyor | |
Hungary | SZEgedi Tudomanyegyetem, II Belgyaszati Klinika | Szeged | |
India | Institution Manipal Hospital | Bangalore | |
India | Postgraduate Institute of Medical Education and Research | Chandigarh | |
India | Apollo Speciality Hospital | Chennai | |
India | Nizam's Institute of Medical Sciences | Hyderabaad | |
India | SMS Medical College Hospital | Jaipur | |
India | Apollo Hospitals, Hyderabad Apollo Hospital Complex | Jubilee Hills | |
India | Shirdi Saibaba Cancer Hospital | Karnataka | |
India | Department of Medical Oncology - Regional Cancer Centre | Kerala | |
India | Regional Cancer Centre | Kerala | |
India | Tata Memorial Centre | Mumbai | |
Israel | Soroka Medical Center | Beer Sheva | |
Israel | Rambam Medical Center | Haifa | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petah Tikva | |
Israel | Sorraski Tel Aviv Medical Center | Tel Aviv | |
Israel | Sheba Medical Center | Tel HaShomer | |
Italy | Azienda Ospedaliero Universitaria di Bologna | Bologna | |
Italy | Universita degli Studi di Perugia | Perugia | |
Italy | Azienda Ospedallera Universitaria Policlinico Tor Vergata | Roma | |
Italy | Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista | Torino | |
Korea, Republic of | Lung Cancer Center - National Cancer Center | Gyeonggi-Do | |
Korea, Republic of | 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 | Samsung Medical Center - Department of Internal Medicine | Ilwon dong, Kangnam-Ku, Seoul | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University College of Medicine | Seoul | |
Mexico | Instituto Nacional De Cancerologia Incan | Delagacion Tlalpan | |
Mexico | Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran | Delagacion Tlalpan | |
Mexico | Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL | Monterrey, Nuevo leon | |
New Zealand | Canterbury Health Laboratories | Christchurch | |
Poland | Klinika Hematologii Instytut Chorob Wewnetrznych | Gdansk | |
Poland | Klinika Hematologii CMUJ | Krakow | |
Poland | Klinika Hematologii - Uniwersytetu Medycznego | Lodz | |
Poland | Klinika Hematologii i Transplantologii Szpiku AM | Lublin | |
Poland | Wojskowy Instytut Medyczny - Klinika Hematologii | Warsawa | |
Poland | Instytut Hematologii i Transfuzjologii | Warszawa | |
Poland | Klinika Hematologii AM | Warszawa | |
Poland | Klinika Nowotworow Ukladu Chlonnego | Warszawa | |
Poland | Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku | Wroclaw | |
Portugal | Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra | Coimbra | |
Portugal | Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E. | Lisboa | |
Portugal | Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia | Lisboa | |
Portugal | Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE | Porto | |
Puerto Rico | San Juan VA Medical Center | San Juan | |
Romania | Spitalul clinic de urgenta | Brasov | |
Romania | Institutul Clinic Fundeni Clinica de Hematologie | Bucuresti | |
Romania | 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 | |
Russian Federation | Arkhangelsk Region Clinical Hospital | Arghangelsk | |
Russian Federation | Altay Regional Oncology Dispensary | Barnaul | |
Russian Federation | Belgorod Regional Oncology Center | Belgorod | |
Russian Federation | Cheliabinsk Regional Oncology Dispensary | Cheliabinsk | |
Russian Federation | Ekaterinburg City Clinical Hospital #7 | Ekaterinburg | |
Russian Federation | 1st Republican Clinical Hospital of Udmurtia | Izhevsk | |
Russian Federation | Cancer Research Center | Moscow | |
Russian Federation | City Oncology Hospital #62 | Moscow | |
Russian Federation | Moscow Region Clinical Research Institute | Moscow | |
Russian Federation | S.P. Botkin Moscow City Clinical Hospital | Moscow | |
Russian Federation | Semashko Central Clinical Hospital #2 | Moscow | |
Russian Federation | Nizhniy Novgorod Region Clinical Hospital | Nizhniy Novgorod | |
Russian Federation | Novosibirsk State Medical University | Novosibirsk | |
Russian Federation | Novosibirsk State Regional Clinical Hospital | Novosibirsk | |
Russian Federation | Medical Scientifical Radiology Center | Obninsk | |
Russian Federation | Republikan Hospital named after V.A. Baranov | Petrozavodsk | |
Russian Federation | Saint Petersburg Pavlov State Medical University | Saint Petersburg | |
Russian Federation | Saratov State Medical University | Saratov | |
Russian Federation | St. Petersburg City Hospital #31 | St. Petersburg | |
Russian Federation | St. Petersburg Clinical Research Institute of Hematology and Transfusiology | St. Petersburg | |
Russian Federation | Tomsk Research Oncology Institute | Tomsk | |
Russian Federation | Republican Clinical Hospital of Bashkorkostan | Ufa | |
Slovakia | FN F.D. Roosevelt - Oddelenie hematologie | Banska Bysterica | |
Slovakia | Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie | Kosice | |
Slovakia | Vychodoslovensky Onkologicky Ustave, a.s. | Kosice | |
Slovakia | Martinska FN, Klinika hematologie a transfuziologie | Martin | |
South Africa | Mary Potter Oncology Centre - Little Company of Mary Hospital | Groenkloof, Pretoria | |
South Africa | Chris Hani Baragwanath Hospital | Johannesburg | |
South Africa | GVI Oncology Clinical Trial Unit | Panorama | Cape Town |
South Africa | East Cape Oncology Centre - St. Georges Hospital | Port Elizabeth | |
Spain | Hospital Durans I Reynals - Institut Catala d'Oncologia | Barcelona | |
Spain | Hospital Germans Trias i Pujol Institut Catala d'Oncologia | Barcelona | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Sweden | Onkologiska kliniken Universitetssjukhuset | Lund | |
Sweden | Centrum for Hematologi Karolinska University Hospital | Stockholm | |
Sweden | Hematologiska kliniken M54 Karolinska University Hospital | Stockholm | |
Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
Thailand | Ramathibodi Hospital, Mahidol University | Bangkok | |
Thailand | Siriraj Hospital, Mahidol University | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University | Chiang Mai | |
Ukraine | Cherkassy Regional Oncology Dispensary | Cherkassy | |
Ukraine | Dnepropetrovsk Regional Clinical Oncology Dispensary | Dnepropetrovsk | |
Ukraine | Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine | Donetsk | |
Ukraine | Khmelnitskiy Regional Hopsital | Khmelnitsky | |
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 | Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary | Poltava | |
Ukraine | Crimean Republic Clinical Oncology Dispensary | Simferopol | |
Ukraine | Zhitomir Gerbachevsky Regional Clinical Hospital | Zhitomir | |
United Kingdom | Aberdeen Royal Infirmary - Department of Haematology | Aberdeen | |
United Kingdom | Addenbrooke's Hospital - Department of Haematology | Cambridge | |
United Kingdom | University Hospital of Wales | Cardiff | |
United Kingdom | Guy's & St. Thomas Hospital | London | |
United Kingdom | Derriford Hospital - Department of Haematology | Plymouth | |
United Kingdom | Taunton & Somerset Hospital | Taunton | |
United States | Central Hematology Oncology Medical Group, Inc | Alhambra | California |
United States | Emory Univeersity ,Winship Cancer Institute | Atlanta | Georgia |
United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
United States | Sinai Hospital | Baltimore | Maryland |
United States | Providence Saint Joseph Medical Center | Burbank | California |
United States | North Idaho Cancer Center | Coeur D Alene | Idaho |
United States | South Carolina Oncology Associates | Columbia | South Carolina |
United States | South Carolina Oncology Associates, PA | Columbia | South Carolina |
United States | The Center for Cancer and Blood Disorders | Fort Worth | Texas |
United States | St. Jude Heritage Medical Group | Fullerton | California |
United States | Southeastern Medical Oncology Center | Goldsboro | North Carolina |
United States | Hattiesburg Clinic | Hattesburg | Missouri |
United States | Oncology Consultants | Houston | Texas |
United States | Investigative Clinical Research of Indiana | Indianapolis | Indiana |
United States | Integrated Community Oncology Network | Jacksonville | Florida |
United States | Kansas City Cancer Center, LLC | Kansas City | Kansas |
United States | Wilshire Oncology Medical Group, Inc. | La Verne | California |
United States | Lancaster Cancer Center, Ltd. | Lancaster | Pennsylvania |
United States | Suburban Hematology-Oncology Associates | Lawrenceville | Georgia |
United States | Pacific Shores Medical Group | Long Beach | California |
United States | University of California, Los Angeles | Los Angeles | California |
United States | University of Southern California | Los Angeles | California |
United States | Louisville Oncology | Louisville | Kentucky |
United States | Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia |
United States | Hematology & Oncology Specialists | Metairie | Louisiana |
United States | Innovative Clinical Research of South Florida | Miami | Florida |
United States | Medical College of Wisconsin Milwaukee | Milwaukee | Wisconsin |
United States | North Valley Hematology Oncology | Mission Hills | California |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Norwalk Medical Group | Norwalk | Connecticut |
United States | East Alabama Medical Center | Opelika, | Alabama |
United States | University of California, Irvine Medical Center | Orange | California |
United States | Ventura County Hematology-Oncology Specialists | Oxnard | California |
United States | The Western Pennsylvania Hospital | Pittsburg | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Cancer Care Associates Medical Group, Inc. | Redondo Beach | California |
United States | South Texas Oncology and Hematology | San Antonio | Texas |
United States | Central Coast Medical Oncology Corporation | Santa Maria | California |
United States | Siouxland Hematolgoy-Oncology Associates | Sioux City | Iowa |
United States | Hematology Oncology PC | Stamford | Connecticut |
United States | Palm Beach Cancer Institute | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Millennium Pharmaceuticals, Inc. | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Thailand, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first. | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | No |
Secondary | Overall Response Rate | 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. | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | No |
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