- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05733650
Programa de Acceso Ampliado para Epcoritamab
Programa de acceso ampliado (EAP) para proporcionar epcoritamab (GEN3013) a pacientes elegibles con linfoma de células B grandes en recaída o refractario
The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons.
Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.
Tipo de estudio
Tipo de acceso ampliado
- Tratamiento IND/Protocolo
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must be 18 years of age or older
- R/R CD20+ mature B-cell neoplasm
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
- ≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-CD20 monoclonal antibody (mAb)
- Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials.
- Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States.
- Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program.
Exclusion Criteria:
- Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
- Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
- Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed.
- Active hepatitis B or hepatitis C
- Known clinically significant cardiac disease
- Pregnancy or breastfeeding
- Known hypersensitivity to allopurinol or rasburicase
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GCT3013-101
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