Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Study Overview
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Brief Summary
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Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: Progression Free Survival Overall Survival Response Duration

Detailed Description
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The screening period = up to 4 weeks prior to the first administration of combined therapy The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients. The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.

Official Title
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An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

Conditions
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Diffuse Large B-Cell Lymphoma

Intervention / Treatment
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* Drug: SAR3419
* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) Relapsed or refractory after at least one standard treatment including rituximab CD19 and CD20 positive disease Exclusion criteria: No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm) 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR3419 + Rituximab<br>Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent. | Drug: SAR3419<br>* Pharmaceutical form:solution for infusion Route of administration: Intravenous<br>Drug: rituximab<br>* Pharmaceutical form:solution for infusion Route of administration: intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving an Objective Response Rate |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events |  | Up to 6 months | 
| Response Duration -Time |  | Up to 24 months after the first infusion of the last patient | 
| Progression Free Survival -Time |  | Up to 24 months after the first infusion of the last patient | 
| Overall survival -Time |  | Up to 24 months after the first infusion of the last patient |