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

July 16, 2012 updated by: Sanofi

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil Cedex, France, 94010
        • Sanofi-Aventis Investigational Site Number 250004
      • Lille Cedex, France, 59037
        • Sanofi-Aventis Investigational Site Number 250006
      • Pierre Benite Cedex, France, 69495
        • Sanofi-Aventis Investigational Site Number 250001
      • Rennes, France, 35033
        • Sanofi-Aventis Investigational Site Number 250005
      • Rouen Cedex, France, 76038
        • Sanofi-Aventis Investigational Site Number 250003
      • Villejuif Cedex, France, 94805
        • Sanofi-Aventis Investigational Site Number 250002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of DLT(s) at each dose level
Time Frame: during the initial 3-week period of treatment
during the initial 3-week period of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative DLT(s)
Time Frame: over the entire period of treatment
over the entire period of treatment
Incidence of Adverse Events and laboratory abnormalities
Time Frame: study period
study period
Tumor response (complete response, partial response) and duration of the response
Time Frame: study period
study period
Pharmacokinetics parameters
Time Frame: Study period
Study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Bertrand COIFFIER, Professor of Hematology, Centre Hospitalier Lyon Sud, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (ESTIMATE)

November 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TED6829
  • EudraCT 2007-004868-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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