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

Phase 1

Completed

• Conditions: Lymphoma; Non-Hodgkin

• Registration Number: NCT00796731
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of DLT(s) at each dose level	during the initial 3-week period of treatment

Secondary Outcome Measures

Name	Time	Method
Cumulative DLT(s)	over the entire period of treatment
Incidence of Adverse Events and laboratory abnormalities	study period
Tumor response (complete response, partial response) and duration of the response	study period
Pharmacokinetics parameters	Study period

Trial Locations

Locations (6)

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, France