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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SAR3419
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring B-cell lymphoma, NHL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 250004
  • Sanofi-Aventis Investigational Site Number 250006
  • Sanofi-Aventis Investigational Site Number 250001
  • Sanofi-Aventis Investigational Site Number 250005
  • Sanofi-Aventis Investigational Site Number 250003
  • Sanofi-Aventis Investigational Site Number 250002

Outcomes

Primary Outcome Measures

Incidence of DLT(s) at each dose level

Secondary Outcome Measures

Cumulative DLT(s)
Incidence of Adverse Events and laboratory abnormalities
Tumor response (complete response, partial response) and duration of the response
Pharmacokinetics parameters

Full Information

First Posted
November 21, 2008
Last Updated
July 16, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00796731
Brief Title
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
B-cell lymphoma, NHL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SAR3419
Intervention Description
administered by intravenous infusion
Primary Outcome Measure Information:
Title
Incidence of DLT(s) at each dose level
Time Frame
during the initial 3-week period of treatment
Secondary Outcome Measure Information:
Title
Cumulative DLT(s)
Time Frame
over the entire period of treatment
Title
Incidence of Adverse Events and laboratory abnormalities
Time Frame
study period
Title
Tumor response (complete response, partial response) and duration of the response
Time Frame
study period
Title
Pharmacokinetics parameters
Time Frame
Study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand COIFFIER, Professor of Hematology
Organizational Affiliation
Centre Hospitalier Lyon Sud, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 250004
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250006
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250001
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250005
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250003
City
Rouen Cedex
ZIP/Postal Code
76038
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250002
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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