relapsed or progressed Follicular non Hodgkin's Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10061170 Term: Follicle centre lymphoma, follicular grade I, II, III
Conditions
Sponsors
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
Eligibility
Sex/Gender
All
Inclusion criteria
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 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; 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
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 = 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - the antitumor activity in terms of clinical and molecular overall response rate (ORR) after the completion of the treatment;Secondary Objective: 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;Primary end point(s): - clinical and molecular overall response rate | — |
Countries
Italy
Outcome results
None listed