Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
NCT07126236 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-08-17
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.
Conditions
- Large B Cell Lymphoma
Interventions
- DRUG
-
Epcoritamab
Patients will receive 12 cycles of Epcoritamab monotherapy.
- DRUG
-
Epcoritamab, tafasitamab and lenalidomide
Patients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide.
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
Evidenze Health España (CRO)
collaborator UNKNOWN -
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
lead OTHER
Principal Investigators
-
Mariana Bastos-Oreiro · Hospital General Universitario Gregorio Marañón
-
Pau Abrisqueta · Hospital Universitari Vall d'Hebrón
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-04
- Primary Completion
- 2031-12-31
- Completion
- 2031-12-31
Countries
- Spain
Study Locations
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