Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00312845
Other study ID # 26866138-LYM-3001
Secondary ID
Status Completed
Phase Phase 3
First received April 7, 2006
Last updated June 19, 2012
Start date March 2006
Est. completion date July 2010

Study information

Verified date June 2012
Source Millennium Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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).

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

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, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Completed NCT04152148 - A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients Phase 1
Recruiting NCT05096234 - 18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma Phase 2
Recruiting NCT05191225 - Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study Phase 4
Recruiting NCT05623982 - Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03664635 - MB-CART20.1 Lymphoma Phase 1/Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Terminated NCT01699581 - Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant Phase 2
Completed NCT01763398 - Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study N/A
Completed NCT01205503 - Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release Phase 2
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00969462 - Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma Phase 4
Completed NCT00659425 - CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Phase 1
Completed NCT00608907 - An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) Phase 1
Terminated NCT00475332 - Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar Phase 2
Withdrawn NCT00577161 - Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL Phase 3
Completed NCT00533728 - Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma Phase 1
Completed NCT00430352 - MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma. Phase 4
Completed NCT00581646 - Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance N/A