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Closed (no longer recruiting)Last updated: 24 May 2024

EPCORE DLBCL-2: This study is comparing the safety and effectiveness of two treatment regimens that both involve targeted therapies and chemotherapy in people with newly diagnosed Diffuse Large B-Cell LymphomaA 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)

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm 1, participants will receive a new targeted therapy (called epcoritamab) combined with R-CHOP treatment. R-CHOP involves targeted therapy (called rituximab) plus chemotherapy (cyclophosphamide, vincristine and doxorubicin) and a steroid (called prednisone). This will then be followed by further epcoritamab.

In Arm 2, participants will receive R-CHOP followed by further rituximab. Epcoritamab will be administered via subcutaneous injection. Cyclophosphamide, rituximab, vincristine and doxorubicin will be administered via intravenous (IV) infusion. Prednisone will be administered as an oral tablet.

Conditions

This trial is treating patients with newly diagnosed diffuse large B-cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18 - 79

Phase

III

Trial Acronym

EPCORE DLBCL-2

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

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)

Eligibility

Inclusion

  • 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). 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

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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