Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

NCT ID: NCT00549185

Last Updated: 2012-02-14

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma Non-Hodgkin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SAR3419

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.
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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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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TED6828

Identifier Type: -

Identifier Source: org_study_id

NCT00539682

Identifier Type: -

Identifier Source: nct_alias

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