Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients

NCT07714421 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 26-0384NCI-2026-04728
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and/or effective in treating DLBCL in elderly or unfit patients.

Conditions

Diffuse Large B-Cell Lymphoma; Grade 3b Follicular Lymphoma; High Grade B-Cell Lymphoma; Primary Mediastinal Large B-Cell Lymphoma; Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.

  From initiation of treatment to disease progression based on the investigator-based assessments per Lugano criteria or death due to any causes, up to 6 years

Secondary Outcomes (6)

• Overall response rate

  Up to 6 years

• Duration of response

  From the first documentation of CR or PR to disease progression or death, up to 6 years

• Overall survival

  From enrollment until death due to any cause, up to 6 years

• Incidence and severity of adverse events

  Up to 6 years

• Incidence and severity of changes in laboratory values

  Up to 6 years

Study Arms (1)

Treatment (epcoritamab, pola-r-mini-CHP)

EXPERIMENTAL

See Detailed Description

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Doxorubicin; Biological: Epcoritamab; Procedure: Magnetic Resonance Imaging; Drug: Polatuzumab Vedotin; Procedure: Positron Emission Tomography; Drug: Prednisone; Biological: Rituximab

Interventions

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (epcoritamab, pola-r-mini-CHP)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Frindovyx, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Treatment (epcoritamab, pola-r-mini-CHP)

Doxorubicin DRUG

Given IV

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Treatment (epcoritamab, pola-r-mini-CHP)

Magnetic Resonance Imaging PROCEDURE

Undergo brain MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (epcoritamab, pola-r-mini-CHP)

Polatuzumab Vedotin DRUG

Given IV

Also known as: ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, FCU-2711, FCU2711, polatuzumab vedotin-piiq, Polivy, RG 7596, RG-7596, RG7596, Ro 5541077-000

Treatment (epcoritamab, pola-r-mini-CHP)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (epcoritamab, pola-r-mini-CHP)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Treatment (epcoritamab, pola-r-mini-CHP)

Rituximab BIOLOGICAL

Given IV

Also known as: ABP 798, ABP-798, ABP798, BI 695500, BI-695500, BI695500, Blitzima, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT P10, CT-P10, CTP10, GP 2013, GP-2013, GP2013, IDEC 102, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, IDEC102, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF 05280586, PF-05280586, PF05280586, Riabni, Ritemvia, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar GP2013, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, Rituximab-abbs, Rituximab-arrx, Rituximab-blit, Rituximab-pvvr, Rituximab-rite, Rituximab-rixa, Rituximab-rixi, Rixathon, Riximyo, RTXM 83, RTXM-83, RTXM83, Ruxience, Truxima

Treatment (epcoritamab, pola-r-mini-CHP)

Biospecimen Collection PROCEDURE

Undergo blood and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment (epcoritamab, pola-r-mini-CHP)

Epcoritamab BIOLOGICAL

Given SC

Also known as: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, GEN-3013, GEN3013, Tepkinly

Treatment (epcoritamab, pola-r-mini-CHP)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Previously untreated, histologically confirmed DLBCL according to World Health Organization (WHO) 2016 classification
• Documented CD20+ mature B-cell neoplasm according to WHO classification (Swerdlow et al., 2016) or WHO classification (WHO, 2008) based on representative pathology report
• Diffuse large B-cell lymphoma note: Other double-/triple-hit lymphomas are not eligible
• Untreated patients who transform from low grade marginal zone lymphoma (MZL)
• Other aggressive B-non-hodgkin lymphoma (NHL):
• Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)
• High-grade B-cell lymphoma
• Newly diagnosed follicular lymphoma grade 3B (FL 3B)
• At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
• Age \> 80 years, or age 70-79 years and not considered a candidate for full-dose aggressive chemotherapy (R-CHOP) with at least one of the following:
• Impairment in \> 2 activity of daily living (ADL) component and/or
• Impairment in \> 2 instrumental activity of daily living (IADL) component and/or
• Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score of at least 1 comorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \> 8 comorbidities.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of at least 24 weeks

You may not qualify if:

• Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
• Exception: patients who are treated with prednisone as part of pre-phase treatment
• Current grade \> 1 peripheral neuropathy by clinical examination
• Known or suspected chronic active Epstein-Barr virus infection
• Subjects that have transformed from indolent (i) NHL, who have previously been treated with an anthracycline-containing regimen or a CD3-CD20 bispecific antibody
• Patients with known history or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening as confirmed by mandatory magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture
• Aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) \> 3 × upper limit of normal (within 14 days of initiation of study treatment)
• Total bilirubin \> 1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin (within 14 days of initiation of study treatment)
• Patients with a documented history of Gilbert syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible
• International normalization ratio (INR) \> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation (within 14 days of initiation of study treatment)
• Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) \> 1.5 x ULN in the absence of a lupus anticoagulant or therapeutic anticoagulant (within 14 days of initiation of study treatment)
• Estimated creatinine clearance (CrCl) \< 40 mL/min (within 14 days of initiation of study treatment)
• Known clinically significant cardiovascular disease or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) including:
• Unstable arrhythmias

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Genmab: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Specimen Handling; Cyclophosphamide; Doxorubicin; Magnetic Resonance Spectroscopy; polatuzumab vedotin; Prednisone; deltacortene; prednylidene; Rituximab; CT-P10

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sven De Vos

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): December 8, 2026
• Primary Completion (Estimated): October 8, 2030
• Study Completion (Estimated): October 8, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

US (1)