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: * Event-free-survival (EFS) (failure or death from any cause) for all patients. Secondary endpoints: * Complete and partial remission rates for all patients * Response duration (time to relapse or progression) for responder patients * Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients * Overall survival for all patients * Acute and long-term toxicity
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2
ICO-Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
ICO-Hospital Durans i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital La Princesa
Madrid, Madrid, Spain
Hospital MD Anderson
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
...and 9 more locations
The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL
Time frame: 2 years follow-up
Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity
Time frame: 2 years follow-up
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