Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring B-cell Non-Hodgkin's Lymphoma
Eligibility Criteria
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 (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. 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
Sites / Locations
- East Alabama Medical Center
- Central Hematology Oncology Medical Group, Inc
- Comprehensive Blood and Cancer Center
- Providence Saint Joseph Medical Center
- St. Jude Heritage Medical Group
- Wilshire Oncology Medical Group, Inc.
- Pacific Shores Medical Group
- University of Southern California
- University of California, Los Angeles
- North Valley Hematology Oncology
- University of California, Irvine Medical Center
- Ventura County Hematology-Oncology Specialists
- Cancer Care Associates Medical Group, Inc.
- Central Coast Medical Oncology Corporation
- Norwalk Medical Group
- Hematology Oncology PC
- Integrated Community Oncology Network
- Innovative Clinical Research of South Florida
- Palm Beach Cancer Institute
- Emory Univeersity ,Winship Cancer Institute
- Suburban Hematology-Oncology Associates
- Northwest Georgia Oncology Centers, P.C.
- North Idaho Cancer Center
- Investigative Clinical Research of Indiana
- Siouxland Hematolgoy-Oncology Associates
- Kansas City Cancer Center, LLC
- Louisville Oncology
- Hematology & Oncology Specialists
- Sinai Hospital
- Hattiesburg Clinic
- Southeastern Medical Oncology Center
- Oregon Health & Science University
- Lancaster Cancer Center, Ltd.
- The Western Pennsylvania Hospital
- South Carolina Oncology Associates, PA
- South Carolina Oncology Associates
- Vanderbilt University
- The Center for Cancer and Blood Disorders
- Oncology Consultants
- South Texas Oncology and Hematology
- Medical College of Wisconsin Milwaukee
- Higa San Martin
- Hospital Professor Rodolfo Rossi
- Centro Oncologico Integracion Regional
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Peter MacCallum Cancer Institute
- Alfred Hospital
- Royal Melbourne Hospital
- Fremantle Hospital
- ULB Erasme
- AZ Stuivenberg
- AZ Sint Jan
- Institute J. Bordet
- Clinique Notre Dame
- UZ Antwerpen - Universitair Ziekenhuis Antwerpen
- UZ Gent - Universitair Ziekenhuis Gent
- Virga Jesse Ziekenhuis, Dienst Hematologie
- CHR La Citadelle
- CHU Sart Tilman
- Heilig Hart Roeselare
- Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
- Instituto Nacional de Cancer
- Hospital Brigadeiro
- Faculdade de Medicina do ABC
- Toronto Sunnybrook Regional Cancer Centre
- University Health Network - Princess Margaret Hospital
- Juravinski Cancer Centre
- West China Hospital of Sichuan
- Cancer Hospital (Institute), CAMS&PUMC
- Beijing Cancer Hospital
- Peking University People's Hospital
- Affiliated Hospital of the Academy of Military Medical Sciences
- Cancer Center, Sun Yat-Sen University
- Peking University Third Hospital
- RuiJin Hospital
- Cancer Hospital - FuDan University
- Bank of Cyprus Oncology Centre
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- Fakultni nemocnice Olomouc
- Vseobecna Fakultni Nemocnice
- Paijat - Hameen Keskussairaala
- Satakunnan Keskussairaala
- Institut Bergonie
- Clinique Victor Hugo
- Hopital Claude Huriez
- Centre Léon Bérard
- Hopital Hotel Dieu
- Service des Maladies due sang - Hopital haut Leveque
- Centre Hospitalier Lyon Sud
- Onkologische Schwerpunktpraxis
- Universitatsklinikum Munster - Klinik fur Innere Medizin
- Praxis für Hämetologie und Oncologie
- Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
- University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
- University Hospital of Patras - Department of Internal Medicine - Hematology Division
- Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
- Petz Aladar County Hospital
- SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
- Institution Manipal Hospital
- Postgraduate Institute of Medical Education and Research
- Apollo Speciality Hospital
- Nizam's Institute of Medical Sciences
- SMS Medical College Hospital
- Apollo Hospitals, Hyderabad Apollo Hospital Complex
- Shirdi Saibaba Cancer Hospital
- Department of Medical Oncology - Regional Cancer Centre
- Regional Cancer Centre
- Tata Memorial Centre
- Soroka Medical Center
- Rambam Medical Center
- Hadassah Medical Center
- Rabin Medical Center
- Sorraski Tel Aviv Medical Center
- Sheba Medical Center
- Azienda Ospedaliero Universitaria di Bologna
- Universita degli Studi di Perugia
- Azienda Ospedallera Universitaria Policlinico Tor Vergata
- Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
- Lung Cancer Center - National Cancer Center
- Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
- Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
- Samsung Medical Center - Department of Internal Medicine
- Severance Hospital, Yonsei University College of Medicine
- Asan Medical Center
- Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
- Instituto Nacional De Cancerologia Incan
- Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
- Canterbury Health Laboratories
- Klinika Hematologii Instytut Chorob Wewnetrznych
- Klinika Hematologii CMUJ
- Klinika Hematologii - Uniwersytetu Medycznego
- Klinika Hematologii i Transplantologii Szpiku AM
- Wojskowy Instytut Medyczny - Klinika Hematologii
- Instytut Hematologii i Transfuzjologii
- Klinika Hematologii AM
- Klinika Nowotworow Ukladu Chlonnego
- Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
- Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
- Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
- Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE
- San Juan VA Medical Center
- Spitalul clinic de urgenta
- Institutul Clinic Fundeni Clinica de Hematologie
- Spitalul Universitar de Urgenta Hematologie
- Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie
- Spitalul Clinic judetean de urgenta Mures
- Arkhangelsk Region Clinical Hospital
- Altay Regional Oncology Dispensary
- Belgorod Regional Oncology Center
- Cheliabinsk Regional Oncology Dispensary
- Ekaterinburg City Clinical Hospital #7
- 1st Republican Clinical Hospital of Udmurtia
- Cancer Research Center
- S.P. Botkin Moscow City Clinical Hospital
- Moscow Region Clinical Research Institute
- Semashko Central Clinical Hospital #2
- City Oncology Hospital #62
- Nizhniy Novgorod Region Clinical Hospital
- Novosibirsk State Regional Clinical Hospital
- Novosibirsk State Medical University
- Medical Scientifical Radiology Center
- Republikan Hospital named after V.A. Baranov
- Saint Petersburg Pavlov State Medical University
- Saratov State Medical University
- St. Petersburg Clinical Research Institute of Hematology and Transfusiology
- St. Petersburg City Hospital #31
- Tomsk Research Oncology Institute
- Republican Clinical Hospital of Bashkorkostan
- FN F.D. Roosevelt - Oddelenie hematologie
- Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
- Vychodoslovensky Onkologicky Ustave, a.s.
- Martinska FN, Klinika hematologie a transfuziologie
- GVI Oncology Clinical Trial Unit
- Mary Potter Oncology Centre - Little Company of Mary Hospital
- Chris Hani Baragwanath Hospital
- East Cape Oncology Centre - St. Georges Hospital
- Hospital Durans I Reynals - Institut Catala d'Oncologia
- Hospital Germans Trias i Pujol Institut Catala d'Oncologia
- Hospital Universitario La Paz
- Hospital Universitario de Salamanca
- Onkologiska kliniken Universitetssjukhuset
- Centrum for Hematologi Karolinska University Hospital
- Hematologiska kliniken M54 Karolinska University Hospital
- King Chulalongkorn Memorial Hospital
- Ramathibodi Hospital, Mahidol University
- Siriraj Hospital, Mahidol University
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
- Cherkassy Regional Oncology Dispensary
- Dnepropetrovsk Regional Clinical Oncology Dispensary
- Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
- Khmelnitskiy Regional Hopsital
- Kiev Center of Marrow Transplantaion
- Krivoy Rog Oncology Dispensary
- Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
- Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
- Crimean Republic Clinical Oncology Dispensary
- Zhitomir Gerbachevsky Regional Clinical Hospital
- Aberdeen Royal Infirmary - Department of Haematology
- Addenbrooke's Hospital - Department of Haematology
- University Hospital of Wales
- Guy's & St. Thomas Hospital
- Derriford Hospital - Department of Haematology
- Taunton & Somerset Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bortezomib + Rituximab
Rituximab