Previously untreated and symptomatic patients with histologically proven CD20-positive marginal zone B-cell lymphoma (MZL) in need of systemic treatment
Conditions
Brief summary
a) Complete Response (CR) rate at 12 months b) PFS at 5 years assessed by the investigators, according to revised response criteria for malignant lymphomas, from study entry to death from any cause or PD
Detailed description
Acute and long-term safety evaluated by assessment of laboratory parameters and adverse events coded with NCI Common Toxicity Criteria, version 4.0, Complete Response rate at 24 months, Overal Response Rate (ORR) at 12 and 24 months, Overall Survival
Interventions
DRUGMabThera 500 mg concentrate for solution for infusion
Sponsors
Association International Extranodal Lymphoma Study Group (IELSG)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Complete Response (CR) rate at 12 months b) PFS at 5 years assessed by the investigators, according to revised response criteria for malignant lymphomas, from study entry to death from any cause or PD | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute and long-term safety evaluated by assessment of laboratory parameters and adverse events coded with NCI Common Toxicity Criteria, version 4.0, Complete Response rate at 24 months, Overal Response Rate (ORR) at 12 and 24 months, Overall Survival | — |
Countries
Belgium, France, Italy, Portugal
Outcome results
None listed