Last updated 13 days ago
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
360 patients around the world
Available in United States, Mexico, Belgium
Genmab
2Research sites
360Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Diffuse large B-cell lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Eastern Cooperative Oncology Group Performance status score of 0 to 2.Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.Participant must meet at least 1 of the following criteria.Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria.Unable to receive CAR-T therapy due to fitness and/or comorbidity.Lymphocyte apheresis failure.Unwilling to receive CAR-T therapy.Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.Must have measurable disease.Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study.
- Evidencia actual de linfoma primario del sistema nervioso central o compromiso conocido del sistema nervioso central por linfoma, incluida la enfermedad leptomeníngea, al momento de la selección.History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).Documented refractoriness to lenalidomide.
Sites
Centro Oncológico Internacional - COI - Guadalajara
Recruiting
Centro de Investigación Clínica Chapultepec S. A. de C. V. - Morelia
Recruiting
StudyEPCORE DLBCL-4
SponsorGenmab
Study typeInterventional
Conditions
Diffuse large B-cell lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06508658
