| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07126236 | Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma | PHASE2 | RECRUITING | 80 | — | — | Aug 4, 2025 | Dec 1, 2031 | Aug 17, 2025 | 15 | Spain |
The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR at any moment since initiation. The CRR will be assessed by PET-CT according to Lugano Classification and is defined as the proportion of patients who achieve a best response of complete response (CR) at any moment since initiation of Epcoritamab first administration.
| Arm | Type | Description |
|---|---|---|
| EPCO monotherapy | EXPERIMENTAL | Epcoritamab in monotherapy will be administred until cycle 12. |
| Combination therapy | EXPERIMENTAL | 3 cycles of Epcoritamab in monotherapy will be administred and then Epcoritamab will be administred with Tafasitamab and Lenalidomide from cycle 4 until cycle 15. |
| Name | Type | Description |
|---|---|---|
| Epcoritamab | DRUG | Patients will receive 12 cycles of Epcoritamab monotherapy. |
| Epcoritamab, tafasitamab and lenalidomide | DRUG | Patients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide. |
Inclusion Criteria: 1. Written informed consent must be obtained before any study-specific assessment is performed. 2. Age \>18 years 3. Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL...