NIPH Clinical Trials Search

JRCT ID: jRCT2021220043

Registered date:09/02/2023

A Phase 3 study of Epcoritamab in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedDiffuse Large B-Cell Lymphoma (DLBCL)
Date of first enrollment03/03/2023
Target sample size900
Countries of recruitmentUnited States,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Croatia,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan
Study typeInterventional
Intervention(s)Participants will receive epcoritamab combined with R-CHOP or R-CHOP in 21-day cycles.


Primary OutcomePFS
Secondary OutcomeEFS, CR, OS, MRD

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 80age old
Include criteriaPlanned to receive treatment with 6 cycles of standard 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 be capped at 35% 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 MRI. AND Positron emission tomography (PET)-positive on PET-CT scan. Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening. Laboratory values meeting the criteria laid out in the protocol.
Exclude criteriaHistory 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.

Related Information


Public contact
Name Patients and HCP Contact
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
Affiliation AbbVie GK
Scientific contact
Name Natsuko Satomi
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
Affiliation AbbVie GK