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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: SAR3419


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAR3419|administered by intravenous infusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of DLT(s) at each dose level |  | during the initial 3-week period of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell lymphoma, NHL