SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-Positive B-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00796731

Purpose

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.

Condition	Intervention	Phase
Lymphoma Non-Hodgkin	Drug: SAR3419	Phase I

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Incidence of DLT(s) at each dose level [ Time Frame: during the initial 3-week period of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cumulative DLT(s) [ Time Frame: over the entire period of treatment ] [ Designated as safety issue: Yes ]
Incidence of Adverse Events and laboratory abnormalities [ Time Frame: study period ] [ Designated as safety issue: Yes ]
Tumor response (complete response, partial response) and duration of the response [ Time Frame: study period ] [ Designated as safety issue: No ]
Pharmacokinetics parameters [ Time Frame: Study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

administered by intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of B-cell non Hodgkin's lymphoma
Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
CD19 positive disease by flow cytometry or immunohistochemistry

Exclusion Criteria:

Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
Evidence of cerebral or meningeal involvement by lymphoma
Patients without bi-dimensionally measurable disease
ECOG performance status > 2
Life expectancy less than 3 months
Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Previous radioimmunotherapy within 12 weeks
Known anaphylaxis to infused proteins
HIV, HBV and HCV positivity
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 the compliance with the study
Pregnant or breast-feeding women
Patients 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796731

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

France
Sanofi-Aventis Administrative Office	Recruiting
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Bertrand COIFFIER, Professor of Hematology

Centre Hospitalier Lyon Sud, France

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	TED6829, EudraCT 2007-004868-41
Study First Received:	November 21, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00796731
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

B-cell lymphoma
NHL

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
SARS
B-cell lymphomas

Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009