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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 April 2012 |
Main ID: |
EUCTR2005-005777-30-FI |
Date of registration:
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11/01/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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 - VELCADE with Rituximab vs. Rituximab alone in NHL
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Scientific title:
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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 - VELCADE with Rituximab vs. Rituximab alone in NHL |
Date of first enrolment:
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03/03/2006 |
Target sample size:
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670 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005777-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Finland
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Germany
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Greece
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Italy
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Slovakia
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Man or woman and age 18 years or older
2. Diagnosis of follicular B-NHL of the following subtypes (WHO classification 1997): FL (Grades 1 and 2).
3. 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 (CR, CRu, PR), and the TTP from the first dose of rituximab must have been 6 months or more.
4. 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
5. No active central nervous system lymphoma
6. Eastern Cooperative Oncology Group status equal or smaller than 2
7.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. 8. 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 testing described in Section 9.5, but optional for serum protein testing and future testing.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. 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. 2. Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL. 3. History of disallowed therapies: 4. Prior treatment with VELCADE 5. Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization 6. Nitrosoureas within 6 weeks before randomization 7. Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization 8. Stem cell transplant within 6 months before randomization 9. Major surgery within 2 weeks before randomization 10. Residual toxic effects of previous therapy or surgery of Grade 3 or worse 11. Peripheral neuropathy or neuropathic pain of Grade 2 or worse 12. Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment. 13. History of allergic reaction attributable to compounds containing boron or mannitol 14. Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate 15. Concurrent treatment with another investigational agent 16. Female subject who is pregnant or breast-feeding
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma MedDRA version: 8.1
Classification code 10025320
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Intervention(s)
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Trade Name: MabThera Product Name: MabThera | rituximab 100 mg (10 mg/mL) Pharmaceutical Form:
Trade Name: MabThera Product Name: MabThera | rituximab 500 mg (10 mg/ml) Pharmaceutical Form: Concentrate and solvent for solution for injection
Trade Name: VELCADE Product Name: VELCADE 3.5 mg powder for solution for injection Product Code: PS-341, 26866138-AAA-PB-001 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: bortezomib CAS Number: 179324-69-7 Current Sponsor code: 26866138 Other descriptive name: Boronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl)amino]propyl]amino]butyl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3.5-
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Primary Outcome(s)
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Secondary Objective: Secondary objectives are to determine the: -ORR (CR + CR unconfirmed [CRu] + PR) to VELCADE in combination with rituximab according to modified criteria developed by the International Workshop to Standardize Response Criteria for NHL (IWRC) -Overall CR rate (CR + CRu) -Duration of response -TTP -Overall survival (OS) rate -One-year survival rate. The safety objective is to evaluate the safety and tolerability of VELCADE in combination with rituximab
Exploratory objectives are mentioned in the protocol.
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Primary end point(s): The primary endpoint is Progression Free survival is defined as the interval between the date of randomization and the date of PD or death, whichever is first reported in the intent-to-treat (ITT) population. Subjects who withdraw from the study (i.e., withdrawal of consent, lost to follow-up) or change therapy without documented progression will be censored at the time of the last adequate disease assessment. Subjects who complete the study, have not progressed, and are still alive at the cut-off date of the final analysis will be censored at the last adequate disease assessment. Secondary Endpoints: please refer to the protocol.
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Main Objective: The primary objective of this study is to determine whether VELCADE with rituximab provides benefit to subjects with relapsed or refractory, rituximab naive or sensitive follicular B-NHL relative to treatment with rituximab alone, as assessed by prolongation of PFS
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Secondary ID(s)
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2005-005777-30-GB
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26866138-LYM-3001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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