RecruitingPhase 2NCT07126236

Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma

Response-adaptive to Epcoritamab In First Relapse: A Phase II, Response-adaptive, Open-Label, Multicenter Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma


Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Enrollment

80 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing epcoritamab (a bispecific antibody — a drug that targets cancer cells and activates the immune system to destroy them) in people with large B-cell lymphoma (an aggressive blood cancer) that has relapsed (come back) after one prior treatment. **You may be eligible if...** - You are over 18 years old - You have relapsed or refractory large B-cell lymphoma, including DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or grade 3B follicular lymphoma - Your lymphoma returned after or did not respond to one prior line of therapy - You are in adequate overall health **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have had more than one prior line of treatment (for some cohorts) - You have active autoimmune conditions or recent major infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpcoritamab

Patients will receive 12 cycles of Epcoritamab monotherapy.

DRUGEpcoritamab, tafasitamab and lenalidomide

Patients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide.


Locations(15)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

ICO Badalona

Badalona, Catalonia, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Catalonia, Spain

Hospital San Pedro de Alcántara

Cáceres, Extremadura, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Costa del Sol

Marbella, Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

View Full Details on ClinicalTrials.gov

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NCT07126236


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