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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00796731
First received: November 21, 2008
Last updated: July 16, 2012
Last verified: July 2012
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 77
Study Start Date: October 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SAR3419
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Sanofi-Aventis Investigational Site Number 250004
Creteil Cedex, France, 94010
Sanofi-Aventis Investigational Site Number 250006
Lille Cedex, France, 59037
Sanofi-Aventis Investigational Site Number 250001
Pierre Benite Cedex, France, 69495
Sanofi-Aventis Investigational Site Number 250005
Rennes, France, 35033
Sanofi-Aventis Investigational Site Number 250003
Rouen Cedex, France, 76038
Sanofi-Aventis Investigational Site Number 250002
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Bertrand COIFFIER, Professor of Hematology Centre Hospitalier Lyon Sud, France
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00796731     History of Changes
Other Study ID Numbers: TED6829, EudraCT 2007-004868-41
Study First Received: November 21, 2008
Last Updated: July 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
B-cell lymphoma
NHL

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014