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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR3419 | Drug | Intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicity(ies) at each tested dose level | Study period |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response | Study period | |
| Incidence of Adverse Events | Study period |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C569646 | coltuximab ravtansine |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |