patients with MALT-lymphoma
Conditions
Interventions
Trade Name: VELCADE
Product Name: VELCADE
Product Code: F297
Pharmaceutical Form: Powder for injection*
Sponsors
AKH Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically verified diagnosis of MALT lymphoma of any localization • Disseminated disease upon diagnosis or first or greater relapse after local therapy (including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP-eradication. In addition, also patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study. • Measurable disease • Ann Arbor Stage I-IV • ECOG performance status of 0,1 or 2 (see Appendix ) • Age between 19 and 80 years • Life expectancy of at least 3 months • Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Lymphoma histology other than MALT lymphoma or MALT lymphoma tranforming to diffuse large cell lymphoma (“high grade lymphoma”) • Use of any investigational agent in the month prior to inclusion • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years • Major surgery, other than diagnostic surgery, within the last 4 weeks • Evidence of CNS involvement • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months • Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) <1.0 x 109/L • Patients with active opportunistic infections • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective To evaluate the capacity of bortezomib (Velcade®) to induce objective responses in patients with disseminated MALT lymphoma or at relapse after surgery, radiation and chemotherapy. In addition, also patients with disease refractory to HP-eradication after a minimum follow-up of 12 months will be enrolled.;Secondary Objective: Secondary objectives •To evaluate the safety of bortezomib in this patient population •to evaluate the impact of bortezomib on progression free survival ;Primary end point(s): • Clinical response measured according to standard criteria • Progression free survival • clinical adverse events • laboratory parameters | — |
Countries
Austria
Outcome results
None listed