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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002865-39 | |||
| U1111-1120-0315 | Other Identifier | UTN |
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Primary Objective:
Participants Achieving an Objective Response Rate (Cheson 2007)
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR3419 + Rituximab | Experimental | Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR3419 | Drug | Pharmaceutical form:solution for infusion Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving an Objective Response Rate | 18 weeks |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 040002 | Graz | 8036 | Austria | |||
| Investigational Site Number 250004 |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C569646 | coltuximab ravtansine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| rituximab | Drug | Pharmaceutical form:solution for infusion Route of administration: intravenous |
|
| 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 |
| Créteil |
| 94010 |
| France |
| Investigational Site Number 250009 | Dijon | 21000 | France |
| Investigational Site Number 250006 | Lille | 59037 | France |
| Investigational Site Number 250011 | Marseille | 13273 | France |
| Investigational Site Number 250010 | Montpellier | 34295 | France |
| Investigational Site Number 250008 | Nantes | 44093 | France |
| Investigational Site Number 250007 | Paris | 75475 | France |
| Investigational Site Number 250001 | Pierre-Bénite | 69495 | France |
| Investigational Site Number 250005 | Rennes | 35033 | France |
| Investigational Site Number 250003 | Rouen | 76038 | France |
| Investigational Site Number 250002 | Villejuif | 94805 | France |
| Investigational Site Number 578001 | Oslo | 0440 | Norway |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |