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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04384484 | Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 440 | — | — | Sep 16, 2020 | Jun 30, 2028 | Apr 28, 2026 | 144 | United States, Argentina +19 |
| Arm | Type | Description |
|---|---|---|
| Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R) | EXPERIMENTAL | Part 1 consists of a non-randomized safety run-in period evaluating the study drug for the first 20 participants. Participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m\^2 Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m\^2 Q3W for up to 6 additional cycles. |
| Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R) | EXPERIMENTAL | Randomized participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m\^2 every Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m\^2 Q3W for up to 6 additional cycles. |
| Part 2: Standard Immunochemotherapy (R-GemOx) | ACTIVE_COMPARATOR | Randomized participants will receive R-GemOx consisting of rituximab, gemcitabine and oxaliplatin as a standard immunochemotherapy treatment on Day 1 or Day 2 of each cycle for up to 8 cycles, where 1 Cycle is 2 weeks. R-GemOx will be administered via an intravenous infusion of rituximab 375 mg/m\^2 + gemcitabine 1000 mg/m\^2 + oxaliplatin 100 mg/m\^2 every 2 weeks (Q2W) for up to 8 cycles. |
| Name | Type | Description |
|---|---|---|
| Loncastuximab Tesirine | DRUG | Intravenous Infusion |
| Rituximab | DRUG | Intravenous Infusion |
| Gemcitabine | DRUG | Intravenous Infusion |
| Oxaliplatin | DRUG | Intravenous Infusion |
Inclusion Criteria: * Male or female participant aged 18 years or older * Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization classification (including participants with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma, with MYC and BCL2 and/or BC...