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
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: 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 July 26, 2014