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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00312845
First received: April 7, 2006
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Bortezomib + Rituximab
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ] [ Designated as safety issue: No ]
    Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 676
Study Start Date: March 2006
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib + Rituximab 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.
Active Comparator: Rituximab 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312845

  Hide Study Locations
Locations
United States, Alabama
East Alabama Medical Center
Opelika,, Alabama, United States
United States, California
Central Hematology Oncology Medical Group, Inc
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
St. Jude Heritage Medical Group
Fullerton, California, United States, 92835
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91790
Pacific Shores Medical Group
Long Beach, California, United States, 90813
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of Southern California
Los Angeles, California, United States, 90033
North Valley Hematology Oncology
Mission Hills, California, United States, 91345
University of California, Irvine Medical Center
Orange, California, United States, 92868
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Connecticut
Norwalk Medical Group
Norwalk, Connecticut, United States
Hematology Oncology PC
Stamford, Connecticut, United States
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States
Innovative Clinical Research of South Florida
Miami, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
United States, Georgia
Emory Univeersity ,Winship Cancer Institute
Atlanta, Georgia, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, United States, 30045
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Idaho
North Idaho Cancer Center
Coeur D Alene, Idaho, United States
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
United States, Iowa
Siouxland Hematolgoy-Oncology Associates
Sioux City, Iowa, United States
United States, Kansas
Kansas City Cancer Center, LLC
Kansas City, Kansas, United States, 66210
United States, Kentucky
Louisville Oncology
Louisville, Kentucky, United States
United States, Louisiana
Hematology & Oncology Specialists
Metairie, Louisiana, United States
United States, Maryland
Sinai Hospital
Baltimore, Maryland, United States
United States, Missouri
Hattiesburg Clinic
Hattesburg, Missouri, United States
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27530
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States
United States, Pennsylvania
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, United States, 17601
The Western Pennsylvania Hospital
Pittsburg, Pennsylvania, United States
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Oncology Consultants
Houston, Texas, United States, 777024
South Texas Oncology and Hematology
San Antonio, Texas, United States
United States, Wisconsin
Medical College of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States
Argentina
Hospital Professor Rodolfo Rossi
La Plata - Buenos Aires, Argentina
Higa San Martin
La Plata - Buenos Aires, Argentina
Centro Oncologico Integracion Regional
Mendoza, Argentina
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 3002
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Belgium
ULB Erasme
Anderlecht, Belgium, 1070
AZ Stuivenberg
Antwerpen, Belgium, 2060
AZ Sint Jan
Brugge, Belgium, 8000
Institute J. Bordet
Bruxelles, Belgium, 1000
Clinique Notre Dame
Charleroi, Belgium, 6000
UZ Antwerpen - Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
UZ Gent - Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Virga Jesse Ziekenhuis, Dienst Hematologie
Hasselt, Belgium, 3500
CHU Sart Tilman
Liege, Belgium, 4000
CHR La Citadelle
Liege, Belgium, 4000
Heilig Hart Roeselare
Roeselare, Belgium, 8800
Brazil
Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-00
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Hospital Brigadeiro
Sao Paulo, Brazil, 01404-901
Faculdade de Medicina do ABC
Sao Paulo, Brazil, 09060-650
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada
Canada
Juravinski Cancer Centre
Hamilton, Canada
China, Sichuan
West China Hospital of Sichuan
Chengdu, Sichuan, China, 610041
China
Peking University People's Hospital
Beijing, China, 100044
Affiliated Hospital of the Academy of Military Medical Sciences
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100036
Cancer Hospital (Institute), CAMS&PUMC
Beijing, China, 100021
Cancer Center, Sun Yat-Sen University
Guangzhou, China, 510060
Peking University Third Hospital
Haidian District Beijing, China, 100083
RuiJin Hospital
Shanghai, China, 200025
Cancer Hospital - FuDan University
Shanghai, China, 200032
Cyprus
Bank of Cyprus Oncology Centre
Nikosia, Cyprus, 2006
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 775 20
Vseobecna Fakultni Nemocnice
Praha, Czech Republic, 2
Finland
Paijat - Hameen Keskussairaala
Lahti, Finland, 15850
Satakunnan Keskussairaala
Pori, Finland, 28500
France
Institut Bergonie
Bordeaux, France, 33076
Clinique Victor Hugo
Le Mans, France, 72015
Hopital Claude Huriez
Lille, France, 59037
Centre Léon Bérard
Lyon, France, 69373
Hopital Hotel Dieu
Nantes, France, 44098
Service des Maladies due sang - Hopital haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Germany
Onkologische Schwerpunktpraxis
Herrsching, Germany, 82211
Universitatsklinikum Munster - Klinik fur Innere Medizin
Munster, Germany
Praxis für Hämetologie und Oncologie
Würzburg, Germany, 97070
Greece
Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
Athens, Greece, 11527
University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
Athens, Greece, 12462
University Hospital of Patras - Department of Internal Medicine - Hematology Division
Rio Patras, Greece, 26500
Hungary
Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
Debrecen, Hungary, H-4004
Petz Aladar County Hospital
Gyor, Hungary, 9024
SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
Szeged, Hungary, H-6720
India
Institution Manipal Hospital
Bangalore, India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160 012
Apollo Speciality Hospital
Chennai, India, 6000035
Nizam's Institute of Medical Sciences
Hyderabaad, India, 500 082
SMS Medical College Hospital
Jaipur, India, 302 004
Apollo Hospitals, Hyderabad Apollo Hospital Complex
Jubilee Hills, India
Shirdi Saibaba Cancer Hospital
Karnataka, India, 576 104
Regional Cancer Centre
Kerala, India
Department of Medical Oncology - Regional Cancer Centre
Kerala, India
Tata Memorial Centre
Mumbai, India, 400 012
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, Israel
Italy
Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Universita degli Studi di Perugia
Perugia, Italy, 06122
Azienda Ospedallera Universitaria Policlinico Tor Vergata
Roma, Italy, 00133
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torino, Italy, 10126
Korea, Republic of
Lung Cancer Center - National Cancer Center
Gyeonggi-Do, Korea, Republic of, 411-769
Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
Ilmon-Dong, Kangnam-Ku, Seoul, Korea, Republic of, 135-710
Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, Korea, Republic of, 410-769
Samsung Medical Center - Department of Internal Medicine
Ilwon dong, Kangnam-Ku, Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Mexico
Instituto Nacional De Cancerologia Incan
Delagacion Tlalpan, Mexico, 14080
Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
Delagacion Tlalpan, Mexico, 14000
Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
Monterrey, Nuevo leon, Mexico, 64460
New Zealand
Canterbury Health Laboratories
Christchurch, New Zealand
Poland
Klinika Hematologii Instytut Chorob Wewnetrznych
Gdansk, Poland, 80-952
Klinika Hematologii CMUJ
Krakow, Poland, 31-501
Klinika Hematologii - Uniwersytetu Medycznego
Lodz, Poland, 93-510
Klinika Hematologii i Transplantologii Szpiku AM
Lublin, Poland, 20-081
Wojskowy Instytut Medyczny - Klinika Hematologii
Warsawa, Poland, 00-909
Klinika Nowotworow Ukladu Chlonnego
Warszawa, Poland, 02-781
Instytut Hematologii i Transfuzjologii
Warszawa, Poland, 00-957
Klinika Hematologii AM
Warszawa, Poland, 02-097
Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Wroclaw, Poland, 50-367
Portugal
Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
Lisboa, Portugal, 1649-035
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
Lisboa, Portugal, 1099-023
Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE
Porto, Portugal, 4200-072
Puerto Rico
San Juan VA Medical Center
San Juan, Puerto Rico, 00921
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, Romania
Russian Federation
Arkhangelsk Region Clinical Hospital
Arghangelsk, Russian Federation, 163045
Altay Regional Oncology Dispensary
Barnaul, Russian Federation, 656049
Belgorod Regional Oncology Center
Belgorod, Russian Federation, 308010
Cheliabinsk Regional Oncology Dispensary
Cheliabinsk, Russian Federation, 454087
Ekaterinburg City Clinical Hospital #7
Ekaterinburg, Russian Federation, 620137
1st Republican Clinical Hospital of Udmurtia
Izhevsk, Russian Federation, 426039
S.P. Botkin Moscow City Clinical Hospital
Moscow, Russian Federation, 125101
Semashko Central Clinical Hospital #2
Moscow, Russian Federation, 129128
City Oncology Hospital #62
Moscow, Russian Federation, 143423
Cancer Research Center
Moscow, Russian Federation, 115478
Moscow Region Clinical Research Institute
Moscow, Russian Federation, 129110
Nizhniy Novgorod Region Clinical Hospital
Nizhniy Novgorod, Russian Federation, 603129
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
Medical Scientifical Radiology Center
Obninsk, Russian Federation, 249020
Republikan Hospital named after V.A. Baranov
Petrozavodsk, Russian Federation, 185019
Saint Petersburg Pavlov State Medical University
Saint Petersburg, Russian Federation, 197022
Saratov State Medical University
Saratov, Russian Federation, 410028
St. Petersburg Clinical Research Institute of Hematology and Transfusiology
St. Petersburg, Russian Federation, 191024
St. Petersburg City Hospital #31
St. Petersburg, Russian Federation, 197110
Tomsk Research Oncology Institute
Tomsk, Russian Federation, 634028
Republican Clinical Hospital of Bashkorkostan
Ufa, Russian Federation, 450005
Slovakia
FN F.D. Roosevelt - Oddelenie hematologie
Banska Bysterica, Slovakia, 97517
Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
Kosice, Slovakia, 040 11
Vychodoslovensky Onkologicky Ustave, a.s.
Kosice, Slovakia, 041 90
Martinska FN, Klinika hematologie a transfuziologie
Martin, Slovakia, 036 59
South Africa
GVI Oncology Clinical Trial Unit
Panorama, Cape Town, South Africa
Mary Potter Oncology Centre - Little Company of Mary Hospital
Groenkloof, Pretoria, South Africa, 0181
Chris Hani Baragwanath Hospital
Johannesburg, South Africa
East Cape Oncology Centre - St. Georges Hospital
Port Elizabeth, South Africa
Spain
Hospital Germans Trias i Pujol Institut Catala d'Oncologia
Barcelona, Spain, 08916
Hospital Durans I Reynals - Institut Catala d'Oncologia
Barcelona, Spain, 08907
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Sweden
Onkologiska kliniken Universitetssjukhuset
Lund, Sweden
Hematologiska kliniken M54 Karolinska University Hospital
Stockholm, Sweden
Centrum for Hematologi Karolinska University Hospital
Stockholm, Sweden
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, Thailand, 50200
Ukraine
Cherkassy Regional Oncology Dispensary
Cherkassy, Ukraine, 18009
Dnepropetrovsk Regional Clinical Oncology Dispensary
Dnepropetrovsk, Ukraine, 46055
Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
Donetsk, Ukraine, 83045
Khmelnitskiy Regional Hopsital
Khmelnitsky, Ukraine, 29000
Kiev Center of Marrow Transplantaion
Kiev, Ukraine, 03115
Krivoy Rog Oncology Dispensary
Krivoy Rog, Ukraine
Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
Lviv, Ukraine, 79044
Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
Poltava, Ukraine, 36024
Crimean Republic Clinical Oncology Dispensary
Simferopol, Ukraine
Zhitomir Gerbachevsky Regional Clinical Hospital
Zhitomir, Ukraine, 10002
United Kingdom
Aberdeen Royal Infirmary - Department of Haematology
Aberdeen, United Kingdom
Addenbrooke's Hospital - Department of Haematology
Cambridge, United Kingdom, CB2 2QQ
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XN
Guy's & St. Thomas Hospital
London, United Kingdom, SE1 9RT
Derriford Hospital - Department of Haematology
Plymouth, United Kingdom, PL6 8DH
Taunton & Somerset Hospital
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00312845     History of Changes
Other Study ID Numbers: 26866138-LYM-3001
Study First Received: April 7, 2006
Results First Received: June 29, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
B-cell Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 16, 2014