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

JRCT ID: jRCT2021220043

Registered date:09/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Diffuse Large B-Cell Lymphoma (DLBCL)
• Date of first enrollment: 03/03/2023
• Target sample size: 900
• Countries of recruitment: United 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 type: Interventional
• Intervention(s): Participants will receive epcoritamab combined with R-CHOP or R-CHOP in 21-day cycles.

Outcome(s)

• Primary Outcome: PFS
• Secondary Outcome: EFS, CR, OS, MRD

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Planned 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 criteria

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.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary ID(s): NCT05578976