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 (REPIFIR)

NCT07126236 Phase 2 RECRUITING

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.

Details

Lead sponsor	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Phase	Phase 2
Status	RECRUITING
Enrolment	80
Start date	2025-08-04
Completion	2031-12

Conditions

• Large B Cell Lymphoma

Interventions

• Epcoritamab
• Epcoritamab, tafasitamab and lenalidomide

Primary outcomes

• Efficacy of Epcoritamab monotherapy — Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.
  The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR at any moment since initiation. The CRR will be assessed by PET-CT according to Lugano Classification and is defined as the proportion of patients who achieve a best response of complete response (CR) at any moment since initiation of Epcoritamab first administration.

Countries

Spain