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Clinical Trials List

Protocol NumberM20-621
NCT Number(ClinicalTrials.gov Identfier)NCT05578976
Active

2023-02-01 - 2030-01-31

Phase III

Recruiting4

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉鴻霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator ZHENG-WEI ZHOU Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Diffuse Large B-Cell Lymphoma

Objectives

The primary objective of this trial is to evaluate the addition of epcoritamab compared with 6 cycles of standard R-CHOP alone followed by 2 cycles of rituximab in subjects with newly diagnosed DLBCL and an IPI of 2-5. Whether 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab prolongs progression-free survival (PFS).

Test Drug

Epcoritamab

Active Ingredient

Epcoritamab
Epcoritamab

Dosage Form

Concentrate for Solution for Injection
Concentrate for Solution for Injection

Dosage

N/A
N/A

Endpoints

The primary trial outcome was PFS, defined as the duration from the date of randomization to the date of disease progression or death as determined by the Independent Review Committee (IRC) using Lugano criteria. The main analysis group is the subgroup of subjects whose ethnic group is IPI 3-5.

Inclution Criteria

Inclusion Criteria:

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 fresh or paraffin embedded tissue at Screening.
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). AND
Positron 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.

Exclusion Criteria

Exclusion 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.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    900 participants

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