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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00312845




Registration number
NCT00312845
Ethics application status
Date submitted
7/04/2006
Date registered
11/04/2006
Date last updated
25/06/2012

Titles & IDs
Public title
Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Scientific 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
Secondary ID [1] 0 0
26866138-LYM-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bortezomib + Rituximab
Treatment: Drugs - Rituximab

Experimental: Bortezomib + Rituximab -

Active Comparator: Rituximab -


Treatment: Drugs: 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.

Treatment: Drugs: 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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
676
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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Louisiana
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United States of America
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Maryland
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United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
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La Plata - Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Mendoza
Country [23] 0 0
Belgium
State/province [23] 0 0
Anderlecht
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Liege
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Belgium
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Roeselare
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Brazil
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Rio Grande do Sul
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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Hamilton
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China
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Sichuan
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China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
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Guangzhou
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China
State/province [41] 0 0
Haidian District Beijing
Country [42] 0 0
China
State/province [42] 0 0
Shanghai
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Cyprus
State/province [43] 0 0
Nikosia
Country [44] 0 0
Czech Republic
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Brno
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Czech Republic
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Hradec Kralove
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Olomouc
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Czech Republic
State/province [47] 0 0
Praha
Country [48] 0 0
Finland
State/province [48] 0 0
Lahti
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Finland
State/province [49] 0 0
Pori
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France
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Bordeaux
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France
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Le Mans
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France
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Lille
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France
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Lyon
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France
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Nantes
Country [55] 0 0
France
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Pessac
Country [56] 0 0
France
State/province [56] 0 0
Pierre Benite
Country [57] 0 0
Germany
State/province [57] 0 0
Herrsching
Country [58] 0 0
Germany
State/province [58] 0 0
Munster
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Germany
State/province [59] 0 0
Würzburg
Country [60] 0 0
Greece
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Athens
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Greece
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Rio Patras
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Szeged
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India
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Bangalore
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India
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Chandigarh
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India
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Chennai
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India
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Hyderabaad
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India
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Jaipur
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India
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Jubilee Hills
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India
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Karnataka
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India
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Kerala
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India
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Mumbai
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Israel
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Tel HaShomer
Country [80] 0 0
Italy
State/province [80] 0 0
Bologna
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Italy
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Perugia
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Italy
State/province [82] 0 0
Roma
Country [83] 0 0
Italy
State/province [83] 0 0
Torino
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Korea, Republic of
State/province [84] 0 0
Gyeonggi-Do
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Ilmon-Dong, Kangnam-Ku, Seoul
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Ilwon dong, Kangnam-Ku, Seoul
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Seoul
Country [89] 0 0
Mexico
State/province [89] 0 0
Delagacion Tlalpan
Country [90] 0 0
Mexico
State/province [90] 0 0
Monterrey, Nuevo leon
Country [91] 0 0
New Zealand
State/province [91] 0 0
Christchurch
Country [92] 0 0
Poland
State/province [92] 0 0
Gdansk
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Poland
State/province [93] 0 0
Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
State/province [96] 0 0
Warsawa
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Poland
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Warszawa
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Poland
State/province [98] 0 0
Wroclaw
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Portugal
State/province [99] 0 0
Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Puerto Rico
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San Juan
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Romania
State/province [103] 0 0
Brasov
Country [104] 0 0
Romania
State/province [104] 0 0
Bucuresti
Country [105] 0 0
Romania
State/province [105] 0 0
Iasi
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Romania
State/province [106] 0 0
Targu Mures
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Arghangelsk
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Barnaul
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Russian Federation
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Belgorod
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Russian Federation
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Cheliabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Obninsk
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Russian Federation
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Petrozavodsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
State/province [121] 0 0
Tomsk
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Russian Federation
State/province [122] 0 0
Ufa
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Slovakia
State/province [123] 0 0
Banska Bysterica
Country [124] 0 0
Slovakia
State/province [124] 0 0
Kosice
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Slovakia
State/province [125] 0 0
Martin
Country [126] 0 0
South Africa
State/province [126] 0 0
Cape Town
Country [127] 0 0
South Africa
State/province [127] 0 0
Groenkloof, Pretoria
Country [128] 0 0
South Africa
State/province [128] 0 0
Johannesburg
Country [129] 0 0
South Africa
State/province [129] 0 0
Port Elizabeth
Country [130] 0 0
Spain
State/province [130] 0 0
Barcelona
Country [131] 0 0
Spain
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Madrid
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Spain
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Salamanca
Country [133] 0 0
Sweden
State/province [133] 0 0
Lund
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Sweden
State/province [134] 0 0
Stockholm
Country [135] 0 0
Thailand
State/province [135] 0 0
Bangkok
Country [136] 0 0
Thailand
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Chiang Mai
Country [137] 0 0
Ukraine
State/province [137] 0 0
Cherkassy
Country [138] 0 0
Ukraine
State/province [138] 0 0
Dnepropetrovsk
Country [139] 0 0
Ukraine
State/province [139] 0 0
Donetsk
Country [140] 0 0
Ukraine
State/province [140] 0 0
Khmelnitsky
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Ukraine
State/province [141] 0 0
Kiev
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Ukraine
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Krivoy Rog
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Ukraine
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Lviv
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Ukraine
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Poltava
Country [145] 0 0
Ukraine
State/province [145] 0 0
Simferopol
Country [146] 0 0
Ukraine
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Zhitomir
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Aberdeen
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambridge
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United Kingdom
State/province [149] 0 0
Cardiff
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United Kingdom
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London
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United Kingdom
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Plymouth
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United Kingdom
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Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Millennium Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00312845
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Millennium Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00312845