lymphoma of MALT
Conditions
Sponsors
International Extranodal Lymphoma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the antitumor activity, in terms of sum of complete and partial responses (ORR);Secondary Objective: • 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.;Primary end point(s): the antitumor activity Response duration (RD) Progression-free survival (PFS) | — |
Countries
Italy, Spain
Outcome results
None listed