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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00796731
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma Non-Hodgkin Drug: SAR3419 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Intervention Details:
  • Drug: SAR3419
    administered by intravenous infusion

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of DLT(s) at each dose level [ Time Frame: during the initial 3-week period of treatment ]

Secondary Outcome Measures :
  1. Cumulative DLT(s) [ Time Frame: over the entire period of treatment ]
  2. Incidence of Adverse Events and laboratory abnormalities [ Time Frame: study period ]
  3. Tumor response (complete response, partial response) and duration of the response [ Time Frame: study period ]
  4. Pharmacokinetics parameters [ Time Frame: Study period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796731


Locations
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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
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Principal Investigator: Bertrand COIFFIER, Professor of Hematology Centre Hospitalier Lyon Sud, France
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00796731    
Other Study ID Numbers: TED6829
EudraCT 2007-004868-41
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Sanofi:
B-cell lymphoma
NHL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases