AzTrials
AzTrials

Non-Hodgkin's LymphomaPhase 3NCT00312845

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

A Phase 3 study testing Bortezomib + Rituximab and Rituximab in people with Non-Hodgkin's Lymphoma, run by Millennium Pharmaceuticals, Inc. at 206 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Bortezomib + Rituximab and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
676 participants
Where
206 sitesin 32 countries
Study dates
Mar 2006to Jul 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

206 sites in 32 countries.

206 sites in 32 countries

United States41 sites

  • Central Hematology Oncology Medical Group, Inc

    Alhambra, California, 91801

  • Emory Univeersity ,Winship Cancer Institute

    Atlanta, Georgia

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Sinai Hospital

    Baltimore, Maryland

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • South Carolina Oncology Associates

    Columbia, South Carolina

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas

  • St. Jude Heritage Medical Group

    Fullerton, California, 92835

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27530

  • Hattiesburg Clinic

    Hattesburg, Missouri

  • Oncology Consultants

    Houston, Texas, 777024

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana

  • Integrated Community Oncology Network

    Jacksonville, Florida

  • Kansas City Cancer Center, LLC

    Kansas City, Kansas, 66210

  • Wilshire Oncology Medical Group, Inc.

    La Verne, California, 91790

  • Lancaster Cancer Center, Ltd.

    Lancaster, Pennsylvania, 17601

  • Suburban Hematology-Oncology Associates

    Lawrenceville, Georgia, 30045

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • University of Southern California

    Los Angeles, California, 90033

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Louisville Oncology

    Louisville, Kentucky

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Hematology & Oncology Specialists

    Metairie, Louisiana

  • Innovative Clinical Research of South Florida

    Miami, Florida

  • Medical College of Wisconsin Milwaukee

    Milwaukee, Wisconsin

  • North Valley Hematology Oncology

    Mission Hills, California, 91345

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Norwalk Medical Group

    Norwalk, Connecticut

  • East Alabama Medical Center

    Opelika, Alabama

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania

  • Oregon Health & Science University

    Portland, Oregon

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • South Texas Oncology and Hematology

    San Antonio, Texas

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Siouxland Hematolgoy-Oncology Associates

    Sioux City, Iowa

  • Hematology Oncology PC

    Stamford, Connecticut

  • Palm Beach Cancer Institute

    West Palm Beach, Florida

Other trials in United States

Russia22 sites

  • Arkhangelsk Region Clinical Hospital

    Arghangelsk, 163045

  • Altay Regional Oncology Dispensary

    Barnaul, 656049

  • Belgorod Regional Oncology Center

    Belgorod, 308010

  • Cheliabinsk Regional Oncology Dispensary

    Chelyabinsk, 454087

  • 1st Republican Clinical Hospital of Udmurtia

    Izhevsk, 426039

  • Cancer Research Center

    Moscow, 115478

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125101

  • Moscow Region Clinical Research Institute

    Moscow, 129110

  • Semashko Central Clinical Hospital #2

    Moscow, 129128

  • City Oncology Hospital #62

    Moscow, 143423

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603129

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087

  • Novosibirsk State Medical University

    Novosibirsk, 630091

  • Medical Scientifical Radiology Center

    Obninsk, 249020

  • Republikan Hospital named after V.A. Baranov

    Petrozavodsk, 185019

  • St. Petersburg Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • Saint Petersburg Pavlov State Medical University

    Saint Petersburg, 197022

  • St. Petersburg City Hospital #31

    Saint Petersburg, 197110

  • Saratov State Medical University

    Saratov, 410028

  • Tomsk Research Oncology Institute

    Tomsk, 634028

  • Republican Clinical Hospital of Bashkorkostan

    Ufa, 450005

  • Ekaterinburg City Clinical Hospital #7

    Yekaterinburg, 620137

Other trials in Russia

Belgium11 sites

  • ULB Erasme

    Anderlecht, 1070

  • AZ Stuivenberg

    Antwerp, 2060

  • AZ Sint Jan

    Bruges, 8000

  • Institute J. Bordet

    Brussels, 1000

  • Clinique Notre Dame

    Charleroi, 6000

  • UZ Antwerpen - Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Gent - Universitair Ziekenhuis Gent

    Ghent, 9000

  • Virga Jesse Ziekenhuis, Dienst Hematologie

    Hasselt, 3500

  • CHR La Citadelle

    Liège, 4000

  • CHU Sart Tilman

    Liège, 4000

  • Heilig Hart Roeselare

    Roeselare, 8800

Other trials in Belgium

India10 sites

  • Institution Manipal Hospital

    Bangalore

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160 012

  • Apollo Speciality Hospital

    Chennai, 6000035

  • Nizam's Institute of Medical Sciences

    Hyderabaad, 500 082

  • SMS Medical College Hospital

    Jaipur, 302 004

  • Apollo Hospitals, Hyderabad Apollo Hospital Complex

    Jubilee Hills

  • Shirdi Saibaba Cancer Hospital

    Karnataka, 576 104

  • Department of Medical Oncology - Regional Cancer Centre

    Kerala

  • Regional Cancer Centre

    Kerala

  • Tata Memorial Centre

    Mumbai, 400 012

Other trials in India

Ukraine10 sites

  • Cherkassy Regional Oncology Dispensary

    Cherkassy, 18009

  • Dnepropetrovsk Regional Clinical Oncology Dispensary

    Dnipro, 46055

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

    Donetsk, 83045

  • Khmelnitskiy Regional Hopsital

    Khmelnitsky, 29000

  • Kiev Center of Marrow Transplantaion

    Kiev, 03115

  • Krivoy Rog Oncology Dispensary

    Kryvyi Rih

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

    Lviv, 79044

  • Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary

    Poltava, 36024

  • Crimean Republic Clinical Oncology Dispensary

    Simferopol

  • Zhitomir Gerbachevsky Regional Clinical Hospital

    Zhytomyr, 10002

Other trials in Ukraine

China9 sites

  • Cancer Hospital (Institute), CAMS&PUMC

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100036

  • Peking University People's Hospital

    Beijing, 100044

  • Affiliated Hospital of the Academy of Military Medical Sciences

    Beijing, 100071

  • West China Hospital of Sichuan

    Chengdu, Sichuan, 610041

  • Cancer Center, Sun Yat-Sen University

    Guangzhou, 510060

  • Peking University Third Hospital

    Haidian District Beijing, 100083

  • RuiJin Hospital

    Shanghai, 200025

  • Cancer Hospital - FuDan University

    Shanghai, 200032

Other trials in China

Poland9 sites

  • Klinika Hematologii Instytut Chorob Wewnetrznych

    Gdansk, 80-952

  • Klinika Hematologii CMUJ

    Krakow, 31-501

  • Klinika Hematologii - Uniwersytetu Medycznego

    Lodz, 93-510

  • Klinika Hematologii i Transplantologii Szpiku AM

    Lublin, 20-081

  • Wojskowy Instytut Medyczny - Klinika Hematologii

    Warsaw, 00-909

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 00-957

  • Klinika Hematologii AM

    Warsaw, 02-097

  • Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781

  • Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

    Wroclaw, 50-367

Other trials in Poland

France7 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Clinique Victor Hugo

    Le Mans, 72015

  • Hopital Claude Huriez

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Hopital Hotel Dieu

    Nantes, 44098

  • Service des Maladies due sang - Hopital haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Peter MacCallum Cancer Institute

    East Melbourne, Victoria, 3002

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Israel6 sites

  • 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 HaShomer

Other trials in Israel

South Korea6 sites

  • Lung Cancer Center - National Cancer Center

    Gyeonggi-do, 411-769

  • Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine

    Ilmon-Dong, Kangnam-Ku, Seoul, 135-710

  • Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center

    Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, 410-769

  • Samsung Medical Center - Department of Internal Medicine

    Ilwon Dong, Kangnam-Ku, Seoul, 135-710

  • Severance Hospital, Yonsei University College of Medicine

    Seoul, 120-752

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

United Kingdom6 sites

  • Aberdeen Royal Infirmary - Department of Haematology

    Aberdeen

  • Addenbrooke's Hospital - Department of Haematology

    Cambridge, CB2 2QQ

  • University Hospital of Wales

    Cardiff, CF14 4XN

  • Guy's & St. Thomas Hospital

    London, SE1 9RT

  • Derriford Hospital - Department of Haematology

    Plymouth, PL6 8DH

  • Taunton & Somerset Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Romania5 sites

  • 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

Other trials in Romania

Brazil4 sites

  • Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-00

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050

  • Hospital Brigadeiro

    São Paulo, 01404-901

  • Faculdade de Medicina do ABC

    São Paulo, 09060-650

Other trials in Brazil

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Vseobecna Fakultni Nemocnice

    Prague, 2

Other trials in Czechia

Italy4 sites

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138

  • Universita degli Studi di Perugia

    Perugia, 06122

  • Azienda Ospedallera Universitaria Policlinico Tor Vergata

    Roma, 00133

  • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

    Torino, 10126

Other trials in Italy

Portugal4 sites

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

    Coimbra, 3000-075

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

    Lisbon, 1099-023

  • Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.

    Lisbon, 1649-035

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

    Porto, 4200-072

Other trials in Portugal

Slovakia4 sites

  • FN F.D. Roosevelt - Oddelenie hematologie

    Banska Bysterica, 97517

  • Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie

    Košice, 040 11

  • Vychodoslovensky Onkologicky Ustave, a.s.

    Košice, 041 90

  • Martinska FN, Klinika hematologie a transfuziologie

    Martin, 036 59

Other trials in Slovakia

South Africa4 sites

  • Mary Potter Oncology Centre - Little Company of Mary Hospital

    Groenkloof, Pretoria, 0181

  • Chris Hani Baragwanath Hospital

    Johannesburg

  • GVI Oncology Clinical Trial Unit

    Panorama, Cape Town

  • East Cape Oncology Centre - St. Georges Hospital

    Port Elizabeth

Other trials in South Africa

Spain4 sites

  • Hospital Durans I Reynals - Institut Catala d'Oncologia

    Barcelona, 08907

  • Hospital Germans Trias i Pujol Institut Catala d'Oncologia

    Barcelona, 08916

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Thailand4 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Argentina3 sites

  • Higa San Martin

    La Plata - Buenos Aires

  • Hospital Professor Rodolfo Rossi

    La Plata - Buenos Aires

  • Centro Oncologico Integracion Regional

    Mendoza

Other trials in Argentina

Canada3 sites

  • Juravinski Cancer Centre

    Hamilton

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario

Other trials in Canada

Germany3 sites

  • Onkologische Schwerpunktpraxis

    Herrsching am Ammersee, 82211

  • Universitatsklinikum Munster - Klinik fur Innere Medizin

    Münster

  • Praxis für Hämetologie und Oncologie

    Würzburg, 97070

Other trials in Germany

Greece3 sites

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

    Athens, 11527

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

    Athens, 12462

  • University Hospital of Patras - Department of Internal Medicine - Hematology Division

    Rio Patras, 26500

Other trials in Greece

Hungary3 sites

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

    Debrecen, H-4004

  • Petz Aladar County Hospital

    Győr, 9024

  • SZEgedi Tudomanyegyetem, II Belgyaszati Klinika

    Szeged, H-6720

Other trials in Hungary

Mexico3 sites

  • Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran

    Delagacion Tlalpan, 14000

  • Instituto Nacional De Cancerologia Incan

    Delagacion Tlalpan, 14080

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL

    Monterrey, Nuevo Leon, 64460

Other trials in Mexico

Sweden3 sites

  • Onkologiska kliniken Universitetssjukhuset

    Lund

  • Centrum for Hematologi Karolinska University Hospital

    Stockholm

  • Hematologiska kliniken M54 Karolinska University Hospital

    Stockholm

Other trials in Sweden

Finland2 sites

  • Paijat - Hameen Keskussairaala

    Lahti, 15850

  • Satakunnan Keskussairaala

    Pori, 28500

Other trials in Finland

Cyprus1 site

  • Bank of Cyprus Oncology Centre

    Nicosia, 2006

Other trials in Cyprus

New Zealand1 site

  • Canterbury Health Laboratories

    Christchurch

Other trials in New Zealand

Puerto Rico1 site

  • San Juan VA Medical Center

    San Juan, 00921

Other trials in Puerto Rico

About this study

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.

Being tested
Bortezomib + Rituximab, Rituximab
Keywords
B-cell Non-Hodgkin's Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bortezomib + RituximabDrug

    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.

  • RituximabDrug

    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).

Study groups in NCT00312845
Study groupRoleWhat they receive
Bortezomib + RituximabExperimentalNot described
Receives: Drug: Bortezomib + Rituximab
RituximabActive comparatorNot described
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.

    Measured: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Secondary outcomes (1)

  1. 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.

    Measured: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJun 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00312845
Sponsor's protocol ID
26866138-LYM-3001
Status last verified
Jun 2012
First submitted
7 Apr 2006
Last updated
25 Jun 2012

Publications

  • Zinzani PL, Khuageva NK, Wang H, Garicochea B, Walewski J, Van Hoof A, Soubeyran P, Caballero D, Buckstein R, Esseltine DL, Theocharous P, Enny C, Zhu E, Elsayed YA, Coiffier B. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naive or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. J Hematol Oncol. 2012 Oct 22;5:67. doi: 10.1186/1756-8722-5-67.

    PubMed 23088650

  • Coiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F, Rule S, Teixeira A, Walewski J, de Vos S, Crump M, Shpilberg O, Esseltine DL, Zhu E, Enny C, Theocharous P, van de Velde H, Elsayed YA, Zinzani PL; LYM-3001 study investigators. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. Lancet Oncol. 2011 Aug;12(8):773-84. doi: 10.1016/S1470-2045(11)70150-4. Epub 2011 Jul 1.

    PubMed 21724462

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib + Rituximab and Rituximab in people with Non-Hodgkin's Lymphoma, run by Millennium Pharmaceuticals, Inc. at 206 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in United States, Russia, Belgium, India, Ukraine and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00312845, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2012.

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