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

No results posted yet for this study

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

  • AbbVie

    collaborator INDUSTRY
  • Incyte Corporation

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126236 on ClinicalTrials.gov