drugset / Trial / NCT01015248

Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

NCT01015248 ↗

Phase 2 Completed 60 enrolled Spanish Lymphoma Cooperative Group
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2009-05
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications