Clareo Health | A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genmab
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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.
