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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549185
• Other study ID #: TED6828
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2007
• Last updated: February 13, 2012
• Start date: October 2007
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00539682

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, 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
Intravenous infusion

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicity(ies) at each tested dose level		Study period	Yes
Secondary	Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response		Study period	No
Secondary	Incidence of Adverse Events		Study period	Yes