NCT01015248

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

Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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

Conditions

• MALT LYMPHOMA

Interventions

Type	Name	Description
DRUG	Rituximab and Bendamustine	Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-11-18
• Last updated: 2016-09-07

Locations

19 sites across 1 country: Spain