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Clinical Trials in the USA / NCT05578976
Active, not recruiting Phase 3

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)

NCT05578976 · tracked via the Priya Life Science USA tracker
Sponsor
Genmab
Phase
Phase 3
Started
2023-02-08
Last updated
2026-09-11

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

EpcoritamabCyclophosphamideRituximabVincristineDoxorubicinPrednisone

Epcoritamab: Subcutaneous Injection (SC)

Cyclophosphamide: Intravenous (IV) Injection

Rituximab: IV Infusion

Vincristine: IV Infusion

Doxorubicin: IV Infusion

Prednisone: Oral; Tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
79 Years
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.

Primary outcome measure(s)

Trial sites (331)

FacilityCityRegionStatus
Duplicate_University of Arizona Cancer Center - North Campus /ID# 227463 Tucson Arizona
Yuma Regional Medical Center Cancer Center /ID# 261527 Yuma Arizona
University of Arkansas for Medical Sciences /ID# 225703 Little Rock Arkansas
CBCC Global Research, Inc. /ID# 262037 Bakersfield California
Alta Bates Summit Medical Center for Research /ID# 229427 Berkeley California
Orange Coast Memorial Medical Center /ID# 229632 Fountain Valley California
Providence - St. Jude Medical Center /ID# 262042 Fullerton California
Saddleback Memorial Medical Center /ID# 229631 Laguna Hills California
Long Beach Memorial Medical Ct /ID# 228996 Long Beach California
Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032 Los Alamitos California
University of Southern California /ID# 225443 Los Angeles California
University of California, Los Angeles /ID# 226887 Los Angeles California
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 Aurora Colorado
Duplicate_Cancer Specialists of North Florida /ID# 226826 Jacksonville Florida
Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785 Ocala Florida
Orlando Health Cancer Institute /ID# 232626 Orlando Florida
Straub Medical Center /ID# 229464 Honolulu Hawaii
University of Illinois at Chicago /ID# 226889 Chicago Illinois
Southern IL Univ School of Med /ID# 228999 Springfield Illinois
Springfield Clinic Main Campus /ID# 262584 Springfield Illinois
Carle Cancer Institute /ID# 228338 Urbana Illinois
Parkview Comprehensive Cancer Center /ID# 227026 Fort Wayne Indiana
Goshen Center for Cancer Care /ID# 225534 Goshen Indiana
University of Iowa Health Care /ID# 261945 Des Moines Iowa
Cancer Center of Kansas /ID# 261983 Wichita Kansas
Norton Cancer Institute - St. Matthews /ID# 225420 Louisville Kentucky
University of Maryland, Baltimore /ID# 225421 Baltimore Maryland
Johns Hopkins Hospital /ID# 225369 Baltimore Maryland
American Oncology Partners of Maryland /ID# 226859 Bethesda Maryland
UMass Memorial Medical Center /ID# 226939 Worcester Massachusetts
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462 Ann Arbor Michigan
Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206 Ypsilanti Michigan
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680 Saint Louis Park Minnesota
University of Mississippi Medical Center /ID# 228045 Jackson Mississippi
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014 Billings Montana
NHO Revive Research Institute, LLC /ID# 261113 Lincoln Nebraska
MDACC Cooper /ID# 260320 Camden New Jersey
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654 East Brunswick New Jersey
Morristown Medical Center /ID# 239457 Morristown New Jersey
University of New Mexico /ID# 227332 Albuquerque New Mexico

+ 291 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Genmab trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05578976 on ClinicalTrials.gov ↗ ← All trials in the USA