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About
The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas.
Primary endpoint:
Secondary endpoints:
Enrollment
Sex
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Volunteers
Inclusion criteria
Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
Any stage (Ann Arbor I-IV)
The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)
No evidence of histologic transformation to a high grade lymphoma
Measurable or evaluable disease
Age >18 and <85
ECOG performance status 0-2
Life expectancy of at least 1 year
Written informed consent given according to national/local regulations
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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