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

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

DRUG

Rituximab and Bendamustine

Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

  lead OTHER

Principal Investigators

• Carlos Montalbán, MD · Ramon y Cajal Hospital

• Antonio Salar, MD · Hospital del Mar

• Ana Muntañola, MD · Mutua de Terrassa Hospital

• Mª José Rodríguez, MD · Hospital Universitario de Canarias

• María José Terol, MD · Hospital Clínico de Valencia

• Juan Manuel Sancho, MD · ICO Hospital Germans Trias i Pujol

• Eva Domingo, MD · ICO Hospital Durans i Reynals

• Grande Carlos, MD · 12 de Octubre Hospital

• Carlos Panizo, MD · Clínica Universitaria Navarra

• Miguel Canales, MD · La Paz Hospital

• Raquel Oña, MD · MD Anderson Hospital

• Reyes Arranz, MD · La Princesa Hospital

• Dolores Caballero, MD · Hospital Unisversitario de Salamanca

• José Luis Bello, MD · Complejo Hospitalario Universitario de Santiago

• Joan Bargay, MD · Son Llátzer Hospital

• Luis Palomera, MD · Hospital Clínico de Zaragoza

• Franciaco Javier Peñalver, MD · Fundación Hospital Alcorcón

• Eulogio Conde, MD · Marqués de Valdecilla Hospital

• José Javier Sánchez-Blanco, MD · Morales Meseguer Hospital

• Concepción Nicolás, MD · Central de Asturias Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Spain

Study Locations