E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 sum of complete and partial responses (ORR) |
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E.2.2 | Secondary objectives of the trial |
• Safety, as acute and long term toxicity • Response duration (RD) (time to relapse or progression) in responders • Progression-free survival (PFS) (time to disease progression or death from lymphoma): in all patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at any extranodal site 2. any stage (Ann Arbor I-IV) (see Appendix B) 3. relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or anti- CD20 immunotherapy 4. no evidence of histologic transformation to a high grade lymphoma 5. measurable or evaluable disease 6. age > 18 years 7. full recovery from previous therapy, with life expectancy of at least 6 months 8. ECOG performance status 0-2 (see Appendix C) 9. for primary gastric localized H. pylori-positive disease at diagnosis: a. persistent disease 1 year after documented H. pylori infection eradication b. clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication 10. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks |
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E.4 | Principal exclusion criteria |
1. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer 2. other investigational drugs with 14 days before enrollment 3. evidence of symptomatic central nervous system (CNS) disease 4. severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement 5. evidence of grade 2 peripheral neuropathy within 14 days before enrollment 6. known hypersensitivity to bortezomib, boron or mannitol 7. pregnant or lactating status, confirmation that the subject is not 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 8. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
the antitumor activity Response duration (RD) Progression-free survival (PFS) |
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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 | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |