SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

The screening period = up to 4 weeks prior to SAR3419 administration

The treatment period = from the day of first administration of SAR3419 until the
End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease
progression, unacceptable toxicity or other reasons for therapy discontinuation - After
therapy discontinuation all patients will enter a safety follow-up period of 42 days starting
from the day of administration of the last dose of SAR3419 and ending with the End Of
Treatment visit.

All patients, regardless whether they have progressed or not, will be followed until death or
end of study to evaluate survival for at least 18 months.

Inclusion criteria:

- Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed)
expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity),
based on recent (less than 6 months) or new biopsy.

- At least 1 prior specific therapeutic regimen, one of which should have included
rituximab (patients previously eligible for transplantation: the salvage treatment
followed by intensification and Autologous Stem Cell Transplant (ASCT) will be
considered one regimen).

- Relapsed disease after standard 1st line therapy for aggressive lymphoma - not
eligible for high dose chemotherapy with stem cell support. Relapsed or refractory
disease after two lines of therapy one of which could have included Autologous Stem
Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease
free interval of at least 6 months after completion of last therapy. Refractory is
defined as progression of disease during prior therapy or within 6 months from its
completion.

- Available paraffin-embedded tissue should have been collected no longer than 6 months
prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If
archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.

Exclusion criteria:

- Primary refractory patients

- Patients with primary mediastinal DLBCL

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.