Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.


Criteria:

Inclusion Criteria: - Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy - ECOG performance status 0 to 2 Exclusion Criteria: - Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included) - Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study - Previous radioimmunotherapy within 12 weeks - Known intolerance to infused protein products or maytansinoids - 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 with compliance with the study - Pregnant or breast-feeding women - Patient 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.


NCT ID:

NCT00549185


Primary Contact:

Study Director
Clinical Sciences & Operations
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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