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.
Written informed consent must be obtained before any study-specific assessment is performed.
Age >18 years
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.
PD as best response to first line therapy.
Patients who received more than one prior line of systemic therapy
Patients with detectable Central Nervous System (CNS) lymphoma
creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml/min
direct bilirubin level < 2 x ULN (except in patients with Gilbert's syndrome),
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead sponsor
AbbVie
Collaborator
Incyte Corporation
Collaborator
Evidenze CRO
Collaborator