Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Multi-Dose-Escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-Cell Non Hodgkin's Lymphoma

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Treatment Active 18 and over Pharmaceutical / Industry TED6828
NCT00549185

Trial Description

Summary

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

ICD CSD

Study Director

Public Registry ICD
		Email: GV-Contact-us@sanofi-aventis.com

Trial Sites

U.S.A.

New Jersey

Bridgewater

Sanofi-Aventis - US - Bridgewater

Contact Person

Email: GV-Contact-us@sanofi-aventis.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00549185
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.