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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01205737 | A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects | PHASE1 | COMPLETED | 186 | — | — | Sep 1, 2010 | Sep 1, 2013 | Oct 22, 2013 | 41 | Bulgaria, Estonia +8 |
| Arm | Type | Description |
|---|---|---|
| TL011 | EXPERIMENTAL | - |
| MabThera® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TL011 | BIOLOGICAL | 375 mg/m2 iv every 3 weeks for 8 cycles |
| Rituximab | BIOLOGICAL | 375 mg/m2 iv every 3 weeks for 8 cycles |
Inclusion Criteria: * Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification. 2.CD20+ lymphoma cells at screening * 18-80 (inclusive) years of age at screening * Ann Arbor St...