Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptor
phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) u
| Condition(s) | Large B Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) until cycle 15. Patients will be followed up to 5 years. |
| Who can participate | 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), High-grade B-cell lymphoma (HGBCL); and grade 3B Follicular Lymphoma. Relapsed disease is defined as complete remission to first line therapy followed by a recurrence of the disease after a minimum of 6 months of completion of first-line therapy. A biopsy at the time of relapse is recommended but not mandatory. Refractory disease is defined as no objective response to first line therapy (biopsy not mandatory if diagnostic sample available). Four groups of patients are eligible: * PD as best re |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
| Locations | Zaragoza, Aragon, Spain; Burgos, Castille and León, Spain; Badalona, Catalonia, Spain; Barcelona, Catalonia, Spain; Cáceres, Extremadura, Spain; Madrid, Madrid, Spain (+9 more sites) |
| Start date | 2025-08-04 |
| NCT ID | NCT07126236 |
| Official listing | https://clinicaltrials.gov/study/NCT07126236 |