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 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

  • 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

ArmDescriptionAssigned Intervention
Experimental
Epcoritamab and R-CHOP 		Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral 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 rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (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

Yuma Regional Medical Center /ID# 261527
Yuma, Arizona 85364

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

CBCC Global Research, Inc. /ID# 262037
Bakersfield, California 93309

Alta Bates Summit Medical Center for Research /ID# 229427
Berkeley, California 94705

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

Providence - St. Jude Medical Center /ID# 262042
Fullerton, California 92835

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

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

Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032
Los Alamitos, California 90720-3309

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

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

Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618
Aurora, Colorado 80014

Cancer Specialists of North Florida /ID# 226826
Jacksonville, Florida 32256

Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785
Ocala, Florida 34474-4445
Contact:
Site Coordinator
352-732-4032

UF Health Cancer Center at Orlando Health /ID# 232626
Orlando, Florida 32806

Straub Medical Center /ID# 229464
Honolulu, Hawaii 96813-3097

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

Springfield Clinic Main Campus /ID# 262584
Springfield, Illinois 62703-2403
Contact:
Site Coordinator
217-528-7541

Carle Cancer Institute /ID# 228338
Urbana, Illinois 61801-1645

Parkview Comprehensive Cancer Center /ID# 227026
Fort Wayne, Indiana 46845

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

Cancer Center of Kansas /ID# 261983
Wichita, Kansas 67214

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

University of Maryland Medical Center /ID# 225421
Baltimore, Maryland 21201

Johns Hopkins Hospital /ID# 225369
Baltimore, Maryland 21287

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

UMass Memorial Medical Center /ID# 226939
Worcester, Massachusetts 01605

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

University of Mississippi Medical Center /ID# 228045
Jackson, Mississippi 39216-4500

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

NHO Revive Research Institute, LLC /ID# 261113
Lincoln, Nebraska 68506

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

University of New Mexico /ID# 227332
Albuquerque, New Mexico 87102-4517
Contact:
Site Coordinator
(505) 272-5490

Presbyterian Kaseman Hospital /ID# 262084
Albuquerque, New Mexico 87110
Contact:
Site Coordinator
(505) 272-5490

Presbyterian Rust Medical Center /ID# 262068
Rio Rancho, New Mexico 87124
Contact:
Site Coordinator
(505) 272-5490

New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396
Bronx, New York 10469

Roswell Park Cancer Institute /ID# 239127
Buffalo, New York 14263

NYU Langone Hospital - Long Island /ID# 262412
Mineola, New York 11501

New York Cancer and Blood Specialists- New Hyde Park /ID# 265392
New Hyde Park, New York 11042

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

New York Cancer and Blood Specialists- Manhattan /ID# 265391
New York, New York 10028

Icahn School of Medicine at Mount Sinai /ID# 225370
New York, New York 10029
Contact:
Site Coordinator
646-745-6092

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

New York Cancer and Blood Specialists /ID# 261114
Port Jefferson Station, New York 11776-8060

Novant Health Presbyterian Medical Center /ID# 227753
Charlotte, North Carolina 28204

East Carolina University - Brody School of Medicine /ID# 225992
Greenville, North Carolina 27834

Novant Health Forsyth Medical Center /ID# 228339
Winston-Salem, North Carolina 27103

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

Joe Arrington Cancer Research /ID# 227217
Lubbock, Texas 79410

Baylor Scott & White Medical Center- Temple /ID# 225935
Temple, Texas 76508-0001

Intermountain Medical Center /ID# 231184
Murray, Utah 84107-5701

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 & Innovation /ID# 225432
Tacoma, Washington 98405

MultiCare Regional Cancer Center - Tacoma /ID# 265285
Tacoma, Washington 98405

Hospital Erasto Gaertner /ID# 262593
Curitiba, Puerto Rico 81520-060

Hematology and Oncology Institute /ID# 230054
Manati, Puerto Rico 00674

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

More Details

NCT ID
NCT05578976
Status
Recruiting
Sponsor
Genmab

Study Contact

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