Lymphoma, Mucosa-Associated Lymphoid Tissue
Conditions
Brief summary
The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses) of bortezomib in pretreated MALT lymphomas with more than one prior systemic therapy regimen
Interventions
Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles
Sponsors
International Extranodal Lymphoma Study Group (IELSG)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) 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 9. for primary gastric localized H. pylori-positive disease at diagnosis: 1. persistent disease 1 year after documented H. pylori infection eradication 2. 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 11. no corticosteroids during the last 4 weeks, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms 12. adequate renal function (calculated or measured creatinine clearance \>30 mL/minute), liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal) and bone marrow function 13. no evidence of active opportunistic infections 14. no known HIV infection 15. no active HBV and/or HCV infection 16. no serious medical illness likely to interfere with participation in this clinical study 17. voluntary written informed consent before performance of any study-related procedure 18. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study
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 beta-human chorionic gonadotropin (beta-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 |
|---|---|
| Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses | During treatment and one month after treatment completion |
Secondary
| Measure | Time frame |
|---|---|
| Safety, as acute and long-term toxicity | 18 months after treatment completion |
| Response duration (RD) (time to relapse or progression) in responders | 18 months after treatment completion |
| Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients | 18 months after study completion |
Countries
Switzerland
Outcome results
None listed