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

Starting soon · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07714421

Run by

Jonsson Comprehensive Cancer Center

People needed

20

Starts

2026-12-08

Expected to finish

2031-10-08

Last updated by the study team

2026-07-20

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

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
• No significant pulmonary comorbidities (e.g., history of pneumonitis, severe chronic obstructive pulmonary disease [COPD])
• Left ventricular ejection fraction ≥ 45%
• Creatinine clearance > 40 mL/min
• Exceptions may be made for patients with creatinine clearance < 40 mL/min, provided creatinine is within normal range
• Hemoglobin > 9 g/dL
• Absolute neutrophil counts ≥ 1.0 × 10\^9/L; growth factor support allowed in case of bone marrow involvement
• Platelet counts ≥ 75 × 10\^9/L or, in the presence of bone marrow involvement or splenomegaly, ≥ 50 × 10\^9/L
• Lymphocyte counts < 5 × 10\^9/L
• If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 100 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control
• Before the first dose of epcoritamab, during the trial and for 12 months after last administration of epcoritamab, a woman must be either:

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
• Onset of unstable angina pectoris within 6 months of signing informed consent form (ICF)
• Acute myocardial infarction within 6 months of signing ICF
• Congestive heart failure (New York Heart Association Class III or IV cardiac disease and/or known decrease ejection fraction of < 45%)
• Stroke or intracranial hemorrhage within 6 months prior to signing ICF
• In case of any history of cardiovascular disease, a cardiology consult is required within 60 days of enrollment.
• For patients who are ≥ 75 years old, 2 or more active cardiovascular diseases (any type, ≥ grade 2)
• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy including, but not limited to, myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• Low-dose (≤ 10 mg/day) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed
• Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment < 10 mg/day prednisone or equivalent within 2 weeks prior to first the dose of study drug
• Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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