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Completed

NCT Number: NCT00796731

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin 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 Investigational Site Number 250004, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SAR3419

Drug

administered by intravenous infusion

Primary outcomes

  1. Incidence of DLT(s) at each dose level

    Time frame: during the initial 3-week period of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 24, 2008
Registry last updated
Jul 17, 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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