Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT00549185

Run by

Sanofi

People needed

39

Starts

2007-10-01

Expected to finish

2012-01-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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