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

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

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

• Progression Free Survival
• Overall Survival
• Response Duration

• 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.

Inclusion criteria:

• Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
• Relapsed or refractory after at least one standard treatment including rituximab
• CD19 and CD20 positive disease

Exclusion criteria:

• No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm)
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.