UAMS - Translational Research Institute

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)

Purpose

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Condition

Diffuse Large B-Cell Lymphoma

Eligibility

Eligible Ages: Between 18 Years and 79 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 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 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Epcoritamab and R-CHOP	Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.	Drug: Epcoritamab Subcutaneous Injection (SC) Other names: ABBV-GMAB-3013 Drug: Cyclophosphamide Intravenous (IV) Injection Drug: Rituximab IV Infusion Drug: Vincristine IV Infusion Drug: Doxorubicin IV Infusion Drug: Prednisone Oral; Tablet
Experimental R-CHOP and Rituximab	Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.	Drug: Cyclophosphamide Intravenous (IV) Injection Drug: Rituximab IV Infusion Drug: Vincristine IV Infusion Drug: Doxorubicin IV Infusion Drug: Prednisone Oral; Tablet

Recruiting Locations

University of Arizona Cancer Center - North Campus /ID# 227463
Tucson, Arizona 85719-1478

University of Arkansas for Medical Sciences /ID# 225703
Little Rock, Arkansas 72205

Orange Coast Memorial Medical Center /ID# 229632
Fountain Valley, California 92708

Saddleback Memorial Medical Center /ID# 229631
Laguna Hills, California 92653-3689

Long Beach Memorial Medical Ct /ID# 228996
Long Beach, California 90806-1701

University of Southern California /ID# 225443
Los Angeles, California 90033

University of California, Los Angeles /ID# 226887
Los Angeles, California 90095

Orlando Health /ID# 232626
Orlando, Florida 32806-2134

Southern IL Univ School of Med /ID# 228999
Springfield, Illinois 62702

Parkview Cancer Institute /ID# 227026
Fort Wayne, Indiana 46845-1739

Goshen Center for Cancer Care /ID# 225534
Goshen, Indiana 46526

Mission Cancer and Blood /ID# 261945
Des Moines, Iowa 50314-3017

Norton Cancer Institute - St Matthews /ID# 225420
Louisville, Kentucky 40207

American Oncology Partners of Maryland, PA /ID# 226859
Bethesda, Maryland 20817

Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206
Ypsilanti, Michigan 48197-1051

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680
Saint Louis Park, Minnesota 55416

Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014
Billings, Montana 59102

Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654
East Brunswick, New Jersey 08816

Perlmutter Cancer Center at NYU Langone /ID# 262412
Mineola, New York 11501-4064

NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141
New York, New York 10016-4744

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379
New York, New York 10065-6007

University of Cincinnati /ID# 225374
Cincinnati, Ohio 45267

Kaiser Permanente - Northwest /ID# 225488
Portland, Oregon 97227

Millennium Research & Clinical Development /ID# 228284
Kingwood, Texas 77339-6008

University of Virginia Cancer Center - West Complex /ID# 225433
Charlottesville, Virginia 22903-3363

Vista Oncology - East Olympia /ID# 229375
Olympia, Washington 98506-5028

Multicare Institute for Research and Innovation /ID# 225432
Tacoma, Washington 98405

Pan American Center for Oncology Trials, LLC /ID# 230052
Rio Piedras, Puerto Rico 00935

More Details

NCT ID: NCT05578976
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.