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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796731
• Other study ID #: TED6829
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2008
• Last updated: July 16, 2012
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin

Intervention

Drug:
• SAR3419
administered by intravenous infusion

Locations

Country	Name	City	State
France	Sanofi-Aventis Investigational Site Number 250004	Creteil Cedex
France	Sanofi-Aventis Investigational Site Number 250006	Lille Cedex
France	Sanofi-Aventis Investigational Site Number 250001	Pierre Benite Cedex
France	Sanofi-Aventis Investigational Site Number 250005	Rennes
France	Sanofi-Aventis Investigational Site Number 250003	Rouen Cedex
France	Sanofi-Aventis Investigational Site Number 250002	Villejuif Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLT(s) at each dose level		during the initial 3-week period of treatment	Yes
Secondary	Cumulative DLT(s)		over the entire period of treatment	Yes
Secondary	Incidence of Adverse Events and laboratory abnormalities		study period	Yes
Secondary	Tumor response (complete response, partial response) and duration of the response		study period	No
Secondary	Pharmacokinetics parameters		Study period	No