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SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma

NCT ID: NCT00796731

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Lymphoma Non-Hodgkin

Keywords

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B-cell lymphoma NHL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SAR3419

administered by intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand COIFFIER, Professor of Hematology

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud, France

Locations

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Sanofi-Aventis Investigational Site Number 250004

Créteil, , France

Site Status

Sanofi-Aventis Investigational Site Number 250006

Lille, , France

Site Status

Sanofi-Aventis Investigational Site Number 250001

Pierre-Bénite, , France

Site Status

Sanofi-Aventis Investigational Site Number 250005

Rennes, , France

Site Status

Sanofi-Aventis Investigational Site Number 250003

Rouen, , France

Site Status

Sanofi-Aventis Investigational Site Number 250002

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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EudraCT 2007-004868-41

Identifier Type: -

Identifier Source: secondary_id

TED6829

Identifier Type: -

Identifier Source: org_study_id