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[M20-621] Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

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

Satomi Natsuko

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

Feb. 09, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Diffuse Large B-Cell Lymphoma (DLBCL)

Participants will receive epcoritamab combined with R-CHOP or R-CHOP in 21-day cycles.

PFS

EFS, CR, OS, MRD

Jan. 11, 2023

Yes

Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ URL: https://vivli.org/ourmember/abbvie/

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