drugset / Trial / NCT07126236
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
Phase 2
Recruiting
80 enrolled
Spanish Lymphoma Cooperative Group
AbbVie · collabEvidenze CRO · collabIncyte Corporation · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-04
- Primary completion
- 2031-12
- Completion
- 2031-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epcoritamab | Monoclonal antibody | — | — |
| Subject | Lenalidomide | Other / unclassified | — | — |
| Subject | Tafasitamab | Monoclonal antibody | — | — |