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

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT01015248
Phase
PHASE2
Status
Completed

Conditions

  • MALT LYMPHOMA

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 31, 2009
Status verified
Sep 2016
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab and Bendamustine

Primary Outcome Measure

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 ]

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