VELCADE in MALT Lymphoma Pretreated With More Than One Prior Systemic Therapy

Study Overview
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Brief Summary
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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

Official Title
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Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-Cell Lymphoma of MALT-Type Pretreated With More Than One Prior Systemic Therapy Regimen (X05142)

Conditions
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Lymphoma, Mucosa-Associated Lymphoid Tissue

Intervention / Treatment
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* Drug: Bortezomib (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at any extranodal site any stage (Ann Arbor I-IV) relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or anti-CD20 immunotherapy no evidence of histologic transformation to a high grade lymphoma measurable or evaluable disease age > 18 years full recovery from previous therapy, with life expectancy of at least 6 months ECOG performance status 0-2 for primary gastric localized H. pylori-positive disease at diagnosis: persistent disease 1 year after documented H. pylori infection eradication clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks 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 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 no evidence of active opportunistic infections no known HIV infection no active HBV and/or HCV infection no serious medical illness likely to interfere with participation in this clinical study voluntary written informed consent before performance of any study-related procedure 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: prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1. (CIN1) or localized non-melanomatous skin cancer other investigational drugs with 14 days before enrollment evidence of symptomatic central nervous system (CNS) disease severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment known hypersensitivity to bortezomib, boron or mannitol 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bortezomib (drug)|Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |