Clinical trial NCT00312845: Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: B-cell Non-Hodgkin's Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2006-04-11
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Other outcomes:
Locations:
city: Opelika,
country: United States
facility: East Alabama Medical Center
state: Alabama
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group, Inc
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Mission Hills
country: United States
facility: North Valley Hematology Oncology
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Norwalk
country: United States
facility: Norwalk Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Hematology Oncology PC
state: Connecticut
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Miami
country: United States
facility: Innovative Clinical Research of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Univeersity ,Winship Cancer Institute
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Coeur D Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematolgoy-Oncology Associates
state: Iowa
city: Kansas City
country: United States
facility: Kansas City Cancer Center, LLC
state: Kansas
city: Louisville
country: United States
facility: Louisville Oncology
state: Kentucky
city: Metairie
country: United States
facility: Hematology & Oncology Specialists
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Hattesburg
country: United States
facility: Hattiesburg Clinic
state: Missouri
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Cancer Center, Ltd.
state: Pennsylvania
city: Pittsburg
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Milwaukee
state: Wisconsin
city: La Plata - Buenos Aires
country: Argentina
facility: Higa San Martin
city: La Plata - Buenos Aires
country: Argentina
facility: Hospital Professor Rodolfo Rossi
city: Mendoza
country: Argentina
facility: Centro Oncologico Integracion Regional
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Anderlecht
country: Belgium
facility: ULB Erasme
city: Antwerpen
country: Belgium
facility: AZ Stuivenberg
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Bruxelles
country: Belgium
facility: Institute J. Bordet
city: Charleroi
country: Belgium
facility: Clinique Notre Dame
city: Edegem
country: Belgium
facility: UZ Antwerpen - Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: UZ Gent - Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis, Dienst Hematologie
city: Liege
country: Belgium
facility: CHR La Citadelle
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Roeselare
country: Belgium
facility: Heilig Hart Roeselare
city: Porto Alegre
country: Brazil
facility: Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Sao Paulo
country: Brazil
facility: Hospital Brigadeiro
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina do ABC
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
city: Chengdu
country: China
facility: West China Hospital of Sichuan
state: Sichuan
city: Beijing
country: China
facility: Cancer Hospital (Institute), CAMS&PUMC
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Affiliated Hospital of the Academy of Military Medical Sciences
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-Sen University
city: Haidian District Beijing
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: RuiJin Hospital
city: Shanghai
country: China
facility: Cancer Hospital - FuDan University
city: Nikosia
country: Cyprus
facility: Bank of Cyprus Oncology Centre
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Vseobecna Fakultni Nemocnice
city: Lahti
country: Finland
facility: Paijat - Hameen Keskussairaala
city: Pori
country: Finland
facility: Satakunnan Keskussairaala
city: Bordeaux
country: France
facility: Institut Bergonie
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Pessac
country: France
facility: Service des Maladies due sang - Hopital haut Leveque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Herrsching
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Munster
country: Germany
facility: Universitatsklinikum Munster - Klinik fur Innere Medizin
city: Würzburg
country: Germany
facility: Praxis für Hämetologie und Oncologie
city: Athens
country: Greece
facility: Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
city: Athens
country: Greece
facility: University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
city: Rio Patras
country: Greece
facility: University Hospital of Patras - Department of Internal Medicine - Hematology Division
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
city: Gyor
country: Hungary
facility: Petz Aladar County Hospital
city: Szeged
country: Hungary
facility: SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
city: Bangalore
country: India
facility: Institution Manipal Hospital
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Hyderabaad
country: India
facility: Nizam's Institute of Medical Sciences
city: Jaipur
country: India
facility: SMS Medical College Hospital
city: Jubilee Hills
country: India
facility: Apollo Hospitals, Hyderabad Apollo Hospital Complex
city: Karnataka
country: India
facility: Shirdi Saibaba Cancer Hospital
city: Kerala
country: India
facility: Department of Medical Oncology - Regional Cancer Centre
city: Kerala
country: India
facility: Regional Cancer Centre
city: Mumbai
country: India
facility: Tata Memorial Centre
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Sorraski Tel Aviv Medical Center
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna
city: Perugia
country: Italy
facility: Universita degli Studi di Perugia
city: Roma
country: Italy
facility: Azienda Ospedallera Universitaria Policlinico Tor Vergata
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
city: Gyeonggi-Do
country: Korea, Republic of
facility: Lung Cancer Center - National Cancer Center
city: Ilmon-Dong, Kangnam-Ku, Seoul
country: Korea, Republic of
facility: Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
city: Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do
country: Korea, Republic of
facility: Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
city: Ilwon dong, Kangnam-Ku, Seoul
country: Korea, Republic of
facility: Samsung Medical Center - Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Delagacion Tlalpan
country: Mexico
facility: Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
city: Delagacion Tlalpan
country: Mexico
facility: Instituto Nacional De Cancerologia Incan
city: Monterrey, Nuevo leon
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
city: Christchurch
country: New Zealand
facility: Canterbury Health Laboratories
city: Gdansk
country: Poland
facility: Klinika Hematologii Instytut Chorob Wewnetrznych
city: Krakow
country: Poland
facility: Klinika Hematologii CMUJ
city: Lodz
country: Poland
facility: Klinika Hematologii - Uniwersytetu Medycznego
city: Lublin
country: Poland
facility: Klinika Hematologii i Transplantologii Szpiku AM
city: Warsawa
country: Poland
facility: Wojskowy Instytut Medyczny - Klinika Hematologii
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Klinika Hematologii AM
city: Warszawa
country: Poland
facility: Klinika Nowotworow Ukladu Chlonnego
city: Wroclaw
country: Poland
facility: Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
city: Coimbra
country: Portugal
facility: Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
city: Lisboa
country: Portugal
facility: Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
city: Porto
country: Portugal
facility: Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE
city: San Juan
country: Puerto Rico
facility: San Juan VA Medical Center
city: Brasov
country: Romania
facility: Spitalul clinic de urgenta
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni Clinica de Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Hematologie
city: Iasi
country: Romania
facility: Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie
city: Targu Mures
country: Romania
facility: Spitalul Clinic judetean de urgenta Mures
city: Arghangelsk
country: Russian Federation
facility: Arkhangelsk Region Clinical Hospital
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Dispensary
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Oncology Center
city: Cheliabinsk
country: Russian Federation
facility: Cheliabinsk Regional Oncology Dispensary
city: Ekaterinburg
country: Russian Federation
facility: Ekaterinburg City Clinical Hospital #7
city: Izhevsk
country: Russian Federation
facility: 1st Republican Clinical Hospital of Udmurtia
city: Moscow
country: Russian Federation
facility: Cancer Research Center
city: Moscow
country: Russian Federation
facility: S.P. Botkin Moscow City Clinical Hospital
city: Moscow
country: Russian Federation
facility: Moscow Region Clinical Research Institute
city: Moscow
country: Russian Federation
facility: Semashko Central Clinical Hospital #2
city: Moscow
country: Russian Federation
facility: City Oncology Hospital #62
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Obninsk
country: Russian Federation
facility: Medical Scientifical Radiology Center
city: Petrozavodsk
country: Russian Federation
facility: Republikan Hospital named after V.A. Baranov
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Pavlov State Medical University
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Research Institute of Hematology and Transfusiology
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg City Hospital #31
city: Tomsk
country: Russian Federation
facility: Tomsk Research Oncology Institute
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital of Bashkorkostan
city: Banska Bysterica
country: Slovakia
facility: FN F.D. Roosevelt - Oddelenie hematologie
city: Kosice
country: Slovakia
facility: Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
city: Kosice
country: Slovakia
facility: Vychodoslovensky Onkologicky Ustave, a.s.
city: Martin
country: Slovakia
facility: Martinska FN, Klinika hematologie a transfuziologie
city: Panorama
country: South Africa
facility: GVI Oncology Clinical Trial Unit
state: Cape Town
city: Groenkloof, Pretoria
country: South Africa
facility: Mary Potter Oncology Centre - Little Company of Mary Hospital
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Port Elizabeth
country: South Africa
facility: East Cape Oncology Centre - St. Georges Hospital
city: Barcelona
country: Spain
facility: Hospital Durans I Reynals - Institut Catala d'Oncologia
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol Institut Catala d'Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Lund
country: Sweden
facility: Onkologiska kliniken Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Centrum for Hematologi Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Hematologiska kliniken M54 Karolinska University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncology Dispensary
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk Regional Clinical Oncology Dispensary
city: Donetsk
country: Ukraine
facility: Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
city: Khmelnitsky
country: Ukraine
facility: Khmelnitskiy Regional Hopsital
city: Kiev
country: Ukraine
facility: Kiev Center of Marrow Transplantaion
city: Krivoy Rog
country: Ukraine
facility: Krivoy Rog Oncology Dispensary
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
city: Simferopol
country: Ukraine
facility: Crimean Republic Clinical Oncology Dispensary
city: Zhitomir
country: Ukraine
facility: Zhitomir Gerbachevsky Regional Clinical Hospital
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - Department of Haematology
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital - Department of Haematology
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: Guy's & St. Thomas Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital - Department of Haematology
city: Taunton
country: United Kingdom
facility: Taunton & Somerset Hospital
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.