Last updated 26 days ago
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
500 patients around the world
Available in Argentina, Brazil
AbbVie
14Research sites
500Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Follicular lymphoma
Lymphoma
Non-Hodgkin lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.Participant has:Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND>= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)Eligible to receive R2 per investigator determination.Estimated Creatinine Clearance (CrCl) >= 50 mL/min.
- Documented refractoriness to lenalidomide.Have lenalidomide exposure within 12 months prior to randomization.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Centro de Internación e Investigación Clínica FUNDALEU
Hospital Privado de Córdoba
Clínica de Nefrología Urología y Enfermedades Cardiovasculares - Santa Fe
Beneficência Portuguesa de São Paulo
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Recruiting
Hospital De Clínicas Da Universidade Federal Do Paraná
Recruiting
StudyEPCORE FL-1
SponsorAbbVie
Study typeInterventional
Conditions
Follicular lymphomaNon-Hodgkin lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05409066
