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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Non-Hodgkin; Lymphoma

Treatments: Drug: SAR3419

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549185

TED6828

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)