E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsed or progressed Follicular non Hodgkin's Lymphoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061170 |
E.1.2 | Term | Follicle centre lymphoma, follicular grade I, II, III |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- the antitumor activity in terms of clinical and molecular overall response rate (ORR) after the completion of the treatment |
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E.2.2 | Secondary objectives of the trial |
Clinical secondary objectives are to define - the antitumor activity in terms of clinical and molecular overall response rate after the first two cycles of therapy with VELCADE alone - event free survival (EFS) - safety Biological secondary objectives are to define - molecular mechanisms/biological effects of VELCADE |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. diagnosis of relapsed or progressed disease pretreated with no more than three prior chemotherapy regimen and/or immunochemotherapy; 2. age > 18 years; 3. Karnofsky Performance Status >=50 4. no evidence of transformation to a high grade lymphoma; 5. active disease requiring treatment; 6. two dimensionally measurable disease in at least one site or evaluable disease; 7. VELCADE naïve; 8. life expectancy >6 months; 9. no prior chemotherapy, immunotherapy or radiotherapy in the last 8 weeks; 10. adequate renal function (calculated or measured creatinine clearance > 30 mL/minute), liver function (ASAT/ALAT < 3.0 x upper normal, total bilirubin < 2,5 x upper normal), unless due to lymphoma involvement; 11. LVEF > 50%; 12. no evidence of active opportunistic infections; 13. HbsAg, HCV e HIV negativity. Positive serology for HBV and HCV admitted only upon negativity of HBV-DNA and HCV-RNA tests; 14. no serious medical illness likely to interfere with participation in this clinically study; 15. voluntary Written Informed Consent before performance of any study-related procedures; |
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E.4 | Principal exclusion criteria |
1. prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer; 2. refractory disease (non responding patient to previous treatment); 3. other investigational drug within 28 days before enrollment; 4. evidence of symptomatic central nervous system (CNS) disease; 5. severe impairment of bone marrow function (ANC < 1.5 x 109/L, PLT < 50 x 109/L within 14 days before enrollment), unless due to lymphoma involvement; 6. evidence of >= grade 2 neuropathy within 14 days before enrollment; 7. known hypersensitivity to bortezomib, boron or mannitol; 8. known hypersensitivity or anaphylactic reactions to murine antibodies or proteins; 9.uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 7, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; 10. pregnant or lactating status, confirmation that the subject is no pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post menopausal or surgically sterilized women; |
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E.5 End points |
E.5.1 | Primary end point(s) |
- clinical and molecular overall response rate |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |