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Diffuse Large B-Cell LymphomaPhase 1NCT07714421

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

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma and Grade 3b Follicular Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
8 Dec 2026to 8 Oct 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)
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  • 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:
  • Not of childbearing potential: premenarchal; postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/L or milli-International unit mIU/mL); permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab
  • COVID-19 ELIGIBILITY CRITERIA: Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
  • COVID-19 ELIGIBILITY CRITERIA: If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction [PCR]) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.
  • Note: SARS-CoV-2 diagnostic tests should be applied following local requirements/recommendations
  • COVID-19 ELIGIBILITY CRITERIA: Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:
  • No signs/symptoms suggestive of active SARS-CoV-2 infection
  • Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart
  • COVID-19 ELIGIBILITY CRITERIA: Patients with SARS-CoV-2 antigen or PCR testing positivity within 30 days prior to cycle 1 day 1 are not eligible
  • COVID-19 ELIGIBILITY CRITERIA: Any patient with documented SARS-CoV-2 infection within 6 months prior to planned cycle 1 day 1 must have no persistent respiratory symptoms, no evidence of residual sequelae, and a negative PCR test for SARS-CoV-2
  • COVID-19 ELIGIBILITY CRITERIA: Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection. Note that a past COVID-19 infection may be a risk factor, but if resolved and the subject is vaccinated, it may be allowable to enroll the subject

Who cannot join

  • 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)
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  • 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)
  • Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated
  • Acute or chronic hepatitis C virus (HCV) infection
  • Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction
  • Known human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4) count greater than 200 cells/µL; HIV testing is required at screening only if required per local health authorities or institutional standards
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or early-stage localized prostate cancer (Gleason score < 6 or below, Stage I or II) with no requirement for therapy at any time prior to study are eligible.
  • Patients with a malignancy that has been treated with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for > 2 years before enrollment. Exception will be made for patients with a history of breast cancer that is estrogen receptor-/progesterone receptor-positive for more than 2 years before enrollment who are treated with adjuvant hormonal therapy
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before cycle 1 day 1 (C1D1)
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Recent major surgery within 4 weeks before the start of C1D1
  • Superficial lymph node biopsies for diagnosis is allowed

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Sven De Vos, devos@mednet.ucla.edu

    Sven De Vos

Other trials in United States

About this study

Official title: A Phase I Study of Single Agent Epcoritamab Followed by Epcoritamab Plus Pola-R-Mini-CHP for Elderly/Unfit Patients With Previously Untreated DLBCL

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate whether the addition of epcoritamab to 4- 6 cycles of standard Pola-R-mini-CHP preceded by 2 cycles of epcoritamab monotherapy (E + Pola-mini-CHP) is tolerable and effective.

EXPLORATORY OBJECTIVE:

  1. To include the use of liquid biopsy techniques, specifically PhasED-seq, to assess treatment responses.

OUTLINE:

CYCLE 1: Patients receive polatuzumab vedotin intravenously (IV) and rituximab IV on day 1 and epcoritamab subcutaneously (SC) on day 1, 8, and 15 of the 21 day cycle, in the absence of disease progression or unacceptable toxicity.

CYCLE 2: Patients receive epcoritamab on day 1, 8 and 15 of the 21 day cycle, in the absence of disease progression or unacceptable toxicity.

CYCLE 3-4: Patients receive rituximab IV, polatuzumab vedotin IV, cyclophosphamide IV, doxorubicin IV on day 1, epcoritamab SC on days 1, 8 and 15 and prednisone orally (PO) on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients then undergo disease assessment. Patients with complete remission receive cycles 5-6 and patients not in complete remission receive cycles 5-8.

CYCLES 5-8: Patients receive rituximab IV, polatuzumab vedotin IV, cyclophosphamide IV, doxorubicin IV and epcoritamab SC on day 1 and prednisone PO on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo urine sample collection and brain magnetic resonance imaging (MRI) during screening and positron emission tomography (PET)/computed tomography (CT) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up week 36, week 48 then every 12 weeks through week 94, then every 24 weeks through week 240 then every 48 weeks until 6 years after the first dose of treatment. Patients who discontinue for treatment progression are followed up every every 6 months thereafter.

Being tested
Biospecimen Collection, Computed Tomography, Cyclophosphamide, Doxorubicin, Epcoritamab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and urine sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518

    Given IV

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Given IV

  • EpcoritamabBiological

    Also called Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly

    Given SC

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo brain MRI

  • Polatuzumab VedotinDrug

    Also called ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • RituximabBiological

    Also called ABP 798, ABP-798, ABP798, BI 695500

    Given IV

Study groups in NCT07714421
Study groupRoleWhat they receive
Treatment (epcoritamab, pola-r-mini-CHP)ExperimentalSee Detailed Description
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

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

    Measured: 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)

  1. Overall response rate

    Defined as the proportion of patients achieving a complete response (CR) or partial response (PR) based on Lugano criteria. CR defined as the disappearance of all evidence of disease based on Lugano critera. PR defined as a ≥ 50% reduction in tumor burden based on Lugano criteria. Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.

    Measured: Up to 6 years

  2. Duration of response

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

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

  3. Overall survival

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

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

  4. Incidence and severity of adverse events

    95% confidence intervals will be generated.

    Measured: Up to 6 years

  5. Incidence and severity of changes in laboratory values

    95% confidence intervals will be generated.

    Measured: Up to 6 years

  6. Incidence of dose interruptions, delays, and discontinuations

    95% confidence intervals will be generated.

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start8 Dec 2026 (estimated)
  3. Primary completion8 Oct 2030 (estimated)
  4. Study completion8 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714421
Sponsor's protocol ID
26-0384
Other IDs
NCI-2026-04728
Status last verified
Jul 2026
First submitted
15 Jul 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma and Grade 3b Follicular Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07714421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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