Last updated 17 days ago
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
900 patients around the world
Available in United States, Brazil
AbbVie
6Research sites
900Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Large B-cell lymphoma
Requirements for the patient
To 79 Years
All Gender
Medical requirements
- Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:DLBCL, Not Otherwise Specified (NOS).High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.T-cell/histiocyte-rich large B-cell lymphoma.Epstein Barr virus-positive DLBCL, NOS.Follicular lymphoma Grade 3b.Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.Has at least one target lesion defined as:>= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). ANDPositron emission tomography (PET)-positive on PET-CT scan.Laboratory values meeting the criteria laid out in the protocol.Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
- History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.Clinically significant cardiovascular disease as per the protocol.
Sites
AC Camargo Cancer Center
Recruiting
Beneficência Portuguesa de São Paulo
Recruiting
Hospital Alemão Oswaldo Cruz
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Hospital Amaral Carvalho
Recruiting
Fundação Antônio Prudente - CAPEC - Centro de Apoio à Pesquisa Clínica
Recruiting
StudyEPCORE DLBCL-2
SponsorAbbVie
Study typeInterventional
Conditions
Large B-cell lymphoma
Requirements
To 79 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05578976
