Spots Global Cancer Trial Database for SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
Official Title: 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)
Study ID: NCT00796731
Interventions
Study Description
Brief Summary: The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Secondary objectives are: * to characterize the global safety profile * to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule * to assess preliminary evidence of anti-lymphoma activity.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Investigational Site Number 250004, Creteil Cedex, , France
Sanofi-Aventis Investigational Site Number 250006, Lille Cedex, , France
Sanofi-Aventis Investigational Site Number 250001, Pierre Benite Cedex, , France
Sanofi-Aventis Investigational Site Number 250005, Rennes, , France
Sanofi-Aventis Investigational Site Number 250003, Rouen Cedex, , France
Sanofi-Aventis Investigational Site Number 250002, Villejuif Cedex, , France
Contact Details
Name: Bertrand COIFFIER, Professor of Hematology
Affiliation: Centre Hospitalier Lyon Sud, France
Role: PRINCIPAL_INVESTIGATOR
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