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Completed

NCT Number: NCT00549185

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR3419

Drug

Intravenous infusion

Primary outcomes

  1. Incidence of Dose Limiting Toxicity(ies) at each tested dose level

    Time frame: Study period

Secondary outcomes

  1. Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response

    Time frame: Study period

  2. Incidence of Adverse Events

    Time frame: Study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2007
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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