Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01472887 | SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients | PHASE2 | COMPLETED | 61 | — | — | Jan 1, 2012 | Sep 1, 2016 | Jan 25, 2018 | 28 | United States, Belgium +7 |
| NCT01470456 | Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma | PHASE2 | COMPLETED | 50 | — | — | Nov 1, 2011 | Sep 1, 2014 | Nov 13, 2014 | 13 | Austria, France +1 |
| Arm | Type | Description |
|---|---|---|
| SAR3419 | EXPERIMENTAL | All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation |
| 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 |
|---|---|---|
| SAR3419 | DRUG | Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous |
| rituximab | DRUG | Pharmaceutical form:solution for infusion Route of administration: intravenous |
Inclusion criteria: * Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (\>30% positivity), based on recent (less than 6 months) or new biopsy. * At least 1 prior specific therapeutic regimen, one of w...