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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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26866138-LYM-3001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Outcomes
Primary outcome [1]
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Progression Free Survival
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Assessment method [1]
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Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
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Timepoint [1]
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Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
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Secondary outcome [1]
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Overall Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
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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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2010
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Sample size
Target
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Accrual to date
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Final
676
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Peter MacCallum Cancer Institute - East Melbourne
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Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Fremantle Hospital - Fremantle
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4102 - Woolloongabba
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5000 - Adelaide
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3002 - East Melbourne
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3004 - Melbourne
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3050 - Parkville
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6160 - Fremantle
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Tomsk
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Russian Federation
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Ufa
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Slovakia
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Banska Bysterica
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Slovakia
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Kosice
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Slovakia
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Martin
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South Africa
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Cape Town
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South Africa
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Groenkloof, Pretoria
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Port Elizabeth
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Lund
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Sweden
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Stockholm
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Thailand
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Chiang Mai
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Ukraine
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Cherkassy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Khmelnitsky
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Ukraine
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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
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Ukraine
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Simferopol
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Ukraine
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Zhitomir
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United Kingdom
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Aberdeen
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United Kingdom
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Cambridge
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United Kingdom
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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
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Millennium Pharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00312845
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
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Medical Monitor
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Millennium Pharmaceuticals, Inc.
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00312845
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