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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00539682 |
Primary Objective:
-To determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as single agent every 3 weeks in patients with relapsed or refractory B-cell NHL.
Secondary Objectives:
Condition | Intervention | Phase |
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Lymphoma |
Drug: SAR3419 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Multi-Dose-Escalation, Safety and Pharmacokinetic Study of SAR3419 Administered As a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
SAR3419
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Drug: SAR3419
10 mg/m^2 IV Every 3 Weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anas Younes, MD | 713-792-2860 |
United States, New York | |
Memorial Sloan-Kettering | Recruiting |
New York, New York, United States, 10065 | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Anas Younes, MD |
Principal Investigator: | Anas Younes, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anas Younes, MD/Professor ) |
Study ID Numbers: | 2006-1092 |
Study First Received: | October 2, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00539682 |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma Lymphoma B-Cell NHL SAR3419 CD19 |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders SARS B-cell lymphomas |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |