A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
Inclusion Criteria:
- Diagnosis of B-cell non Hodgkin's lymphoma
- Relapsed or refractory after standard treatments and with no curative option with
conventional therapy (Patients having undergone stem cell transplantation may be
included)
- CD19 positive disease by flow cytometry or immunohistochemistry
Exclusion Criteria:
- Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small
lymphocytic lymphoma may be included)
- Evidence of cerebral or meningeal involvement by lymphoma
- Patients without bi-dimensionally measurable disease
- ECOG performance status > 2
- Life expectancy less than 3 months
- Chemotherapy or radiation therapy or other investigational agents within 4 weeks
prior to entering the study
- Previous radioimmunotherapy within 12 weeks
- Known anaphylaxis to infused proteins
- HIV, HBV and HCV positivity
- Poor kidney, liver and bone marrow functions
- Any serious active disease or co-morbid condition, which, in the opinion of the
principle investigator, will interfere with the safety or the compliance with the
study
- Pregnant or breast-feeding women
- Patients with reproductive potential without effective birth control methods
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.