Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

Status Completed

Clinical Trial Summary

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

• Progression Free Survival

• Overall Survival

• Response Duration

Clinical Trial Description

• The screening period = up to 4 weeks prior to the first administration of combined therapy

• The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.

• The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT01470456
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Completion date: September 2014