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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00549185
First received: October 24, 2007
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Non-Hodgkin
Drug: SAR3419
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence of Dose Limiting Toxicity(ies) at each tested dose level [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SAR3419
    Intravenous infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549185

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00549185     History of Changes
Obsolete Identifiers: NCT00539682
Other Study ID Numbers: TED6828
Study First Received: October 24, 2007
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014