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Non-Hodgkin's B-cell LymphomaPhase 2NCT07588698

Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma

A Phase 2 study testing Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP), Epcoritamab and Dexamethasone in people with Non-Hodgkin's B-cell Lymphoma and Lymphoma Non-Hodgkin, run by Carrie Ho, MD at 2 sites 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

A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP), Epcoritamab and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
15 Nov 2026to 31 Aug 2029
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.
  • Measurable disease per Lugano 2014 criteria.
  • No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.
  • Age ≥18 years
  • Participants must have an International Prognostic Index (IPI) score of 2-5.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
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  • Demonstrates adequate organ function as defined below:
  • Adequate bone marrow function:
  • absolute neutrophil count platelets
  • 1.0 × 10⁹/Litre (L) (with growth factor use allowed)
  • 75 × 10⁹/L
  • Exceptions:
  • Patients may be enrolled despite not meeting the thresholds above if either of the following applies, provided the Absolute Neutrophil Count (ANC) is ≥0.75 × 10⁹/L:
  • The patient has received one prior cycle of chemotherapy off study, and cytopenias at Cycle 2, Day 1 of protocol therapy are believed to be due to recent chemotherapy, provided there is evidence of marrow recovery and no other contraindications.
  • The patient has documented bone marrow involvement by lymphoma, and cytopenias are believed to be disease-related rather than indicative of poor marrow reserve or unrelated pathology. In such cases, enrollment is permitted at the discretion of the investigator if the patient is otherwise eligible and deemed safe to proceed.
  • Adequate hepatic function:
  • Total bilirubin
  • ≤2 × upper limit of normal (ULN) (unless due to Gilbert's)
  • Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT)
  • ≤3 × institutional upper limit of normal
  • Alanine aminotransferase (ALT) Serum glutamic-pyruvic transaminase (SGPT)
  • ≤3 × institutional upper limit of normal
  • Adequate renal function:
  • As assessed by estimated glomerular filtration rate (eGFR)
  • Coagulation:
  • Prothrombin time (PT) International Normalized Ratio (INR) and Activated partial thromboplastin time aPTT
  • ≤1.5 × ULN, unless receiving anticoagulation therapy
  • Left ventricular ejection fraction (LVEF) ≥50% by multigated acquisition (MUGA) or echocardiography at screening.
  • Ability to understand and the willingness to sign a written informed consent document.
  • .Human immunodeficiency virus (HIV)-infected individuals are eligible if the following criteria are met:
  • Serum HIV viral load is < lower limit of detection (LLD) and controlled with antiretroviral therapy for at least 1 year prior to enrollment, with confirmatory testing at screening;
  • CD4 count ≥ 200 cells/microliter (μL) at screening;
  • Subject is receiving antiretroviral regimens in accordance with current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines;
  • No evidence of AIDS-defining illnesses (other than lymphoma diagnosis) or active opportunistic infections;
  • Antiretroviral therapy does not interfere with study medications.
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • The effects of epcoritamab on the developing human fetus are unknown. For this reason, and because bispecific antibodies may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence). Woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab or according to the local prescribing information of the standard of care (SOC) regimens, whichever is the longest. Adequate contraception is defined as highly effective methods of contraception. Also refer to the local prescribing information for information regarding contraceptive requirements for the SOC regimens.
  • A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test before treatment administration on Day 1 of every cycle.
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab or according to the local prescribing information of the SOC regimens, whichever is the longest.
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab or according to the local prescribing information of the SoC regimens, whichever is the longest.
  • Participants must agree not to donate blood for 60 days after receiving the last dose of trial treatment.
  • Participants must have a treating physician at University of California, San Francisco (UCSF) or Zuckerberg San Francisco General Hospital (ZSFGH), receive study treatment under the supervision of the study Principal Investigator or qualified study sub-investigators at the enrolling site, and be willing to comply with study procedures.

Who cannot join

  • History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
  • Any prior treatment with a bispecific antibody targeting CD3 and CD20.
  • Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.
  • Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone >10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.
  • Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
  • Clinically significant cardiovascular disease, including:
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  • Myocardial infarction within 6 months prior to the first dose of epcoritamab, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV), cardiac arrhythmia (NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade 3 or higher), or clinically significant electrocardiogram (ECG) abnormalities
  • Screening 12-lead ECG showing a baseline QT Corrected for Heart Rate using Fridericia's Formula (QTcF) >470 msec
  • Stroke within 6 months prior to first epcoritamab dose
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab.
  • Active hepatitis B Virus (HBV) (Deoxyribonucleic Acid Polymerase Chain Reaction (DNA PCR) -positive) or hepatitis C (Ribonucleic Acid Polymerase Chain Reaction (RNA PCR) -positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for Hepatitis C Virus (HCV) that was intended to eradicate the virus may participate if hepatitis C Ribonucleic acid (RNA) levels are undetectable.
  • Known past or current malignancy other than inclusion diagnosis, except for:
  • Cervical carcinoma of Stage 1B or less
  • Non-invasive basal cell or squamous cell skin carcinoma
  • Non-invasive, superficial bladder cancer
  • Prostate cancer with a current Prostate-Specific Antigen (PSA) level < 0.1 ng/milliliter (mL)
  • Any curable cancer with a complete response (CR) of > 2 years duration.
  • Neuropathy > grade 1 with the exception of neuropathy directly related to lymphoma (e.g., direct nerve compression from tumor).
  • . Female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab; female subjects must also agree not to breastfeed during the entire trial and until 12 months after the last administration of study drug.
  • Male who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.
  • Contraindication to any of the individual drugs of the R-CHOP regimen.

Trial locations and contacts

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

UCSF Hematopoietic Malignancies Clinical Trial Recruitment contact

877-827-3222

HDFCCC.Heme@ucsf.edu

Clinical Trial Recruitment contact

cancertrials@ucsf.edu

United States2 sites

  • Zuckerberg San Francisco General

    San Francisco, California, 94110

    UCSF Hematopoietic Malignancies Clinical Trial Recruitment, 877-827-3222, HDFCCC.Heme@ucsf.edu

    Clinical Trial Recruitment, cancertrials@ucsf.edu

  • University of California, San Francisco

    San Francisco, California, 94143

    UCSF Hematopoietic Malignancies Clinical Trial Recruitment, 877-827-3222, HDFCCC.Heme@ucsf.edu

    cancertrials@ucsf.edu

Other trials in United States

About this study

Official title: Epcoritamab in Combination With R-CHOP Debulking in Newly Diagnosed Patients With Aggressive Non-Hodgkin Lymphoma (DLBCL)

A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the incidence and severity of all grade CRS cytokine release syndrome (CRS) in arm A and arm B.

SECONDARY OBJECTIVES:

  1. To determine the safety and tolerability of the combination of epcoritamab and rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) in both arms and individually.

II. The anti-tumor activity of epcoritamab + R-CHOP. III. To evaluate duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

EXPLORATORY OBJECTIVES:

  1. To evaluate changes in serum cytokine levels with epcoritamab treatment and explore their association with the incidence and severity of CRS.

II. To characterize peripheral T-cell subsets and activation states and explore phenotypic profiles associated with CRS.

OUTLINE:

Participants will receive epcoritamab combined with R-CHOP chemotherapy and dexamethasone. The treatment will be delivered in up to 8 cycles in an outpatient setting. participants are followed at Week 8 and every 3 months for up to one year, or until improvement or stabilization, or until new therapy begins, whichever occurs first.

Being tested
Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP), Epcoritamab, Dexamethasone, Positron Emission Tomography (PET), Blood specimen collection
Keywords
Newly diagnosed B-cell lymphoma patients, Combination immunotherapy chemotherapy, epcoritamab R-CHOP lymphoma trial
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP)Drug

    Also called R-CHOP-21

    Given orally and intravenously (IV)

  • EpcoritamabDrug

    Also called EPKINLY, epcoritamab-bysp

    Given subcutaneously (SC)

  • DexamethasoneDrug

    Given orally

  • Positron Emission Tomography (PET)Procedure or surgery

    Undergo imaging

  • Blood specimen collectionProcedure or surgery

    Perform Blood work

  • QuestionnairesBehavioural

    Participants complete European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  • Computerized tomography (CT)Procedure or surgery

    Undergo Imaging

Study groups in NCT07588698
Study groupRoleWhat they receive
Arm A: Treatment with Standard Dexamethasone (First 6 participants)ExperimentalParticipants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A standard dose of dexamethasone is given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is given on epcoritamab treatment days and for 3 subsequent days. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.
Receives: Drug: Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP); Drug: Epcoritamab; Drug: Dexamethasone; Procedure: Positron Emission Tomography (PET); Procedure: Blood specimen collection; Behavioral: Questionnaires; Procedure: Computerized tomography (CT)
Arm B: Treatment with Modified DexamethasoneExperimentalParticipants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A modified dose of dexamethasone will be given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is administered on epcoritamab treatment days and the following day. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.
Receives: Drug: Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP); Drug: Epcoritamab; Drug: Dexamethasone; Procedure: Positron Emission Tomography (PET); Procedure: Blood specimen collection; Behavioral: Questionnaires; Procedure: Computerized tomography (CT)

What is being measured

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

  1. Cytokine Release Syndrome (CRS) Rate

    The cytokine release syndrome (CRS) rate is defined as the incidence of CRS of any grade during Cycle 2, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria. The proportion and corresponding 95% confidence interval will be reported.

    Measured: Up to day 42

Secondary outcomes (5)

  1. Proportion of Participants with Treatment-emergent Adverse Events

    Proportion of participants with treatment-emergent adverse events, classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The proportion and 95% confidence interval will be reported.

    Measured: Up to 60 days after treatment

  2. Overall Response (OR)

    Overall response (OR) is defined as the proportion of treated participants who obtained an radiographic objective response confirmed complete response (CR) or confirmed partial response (PR) per Lugano Classification. The proportion and 95% confidence interval will be reported.

    Measured: Up to 2 years

  3. Duration of Overall Response

    Duration of overall response is defined as the time from first documentation of complete response (CR) or partial response (PR) to the first occurrence of disease progression, recurrence, or death, whichever occurs first. Patients without progression who are alive at the clinical cutoff will be censored at the date of their last disease assessment. Median, estimates and 95% confidence interval will be reported using the Kaplan-Meier method and Brookmeyer and Crowley method.

    Measured: Up to 2 years

  4. Median Progression-Free Survival (PFS)

    Progression-free survival (PFS) is the time from the first dose of treatment until disease progression or death, whichever occurs first. If neither event occurs, PFS is measured up to the last adequate disease assessment. If a patient is alive but has no tumor assessments after starting treatment, PFS is measured up to the first dose date. Median, estimates and 95% confidence interval will be reported using the Kaplan-Meier method and Brookmeyer and Crowley method.

    Measured: Up to 2 years

  5. Median Overall Survival (OS)

    Overall survival (OS) is the time from the first dose of treatment until death from any cause. Patients who are still alive will be followed up to their last known contact date. Median, estimates and 95% confidence interval will be reported using the Kaplan-Meier method and Brookmeyer and Crowley method.

    Measured: Up to 2 years.

Timeline

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

  1. First posted15 May 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2029 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588698
Sponsor's protocol ID
252526
Other IDs
NCI-2026-03673
Status last verified
Sep 2026
First submitted
7 May 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP), Epcoritamab and Dexamethasone in people with Non-Hodgkin's B-cell Lymphoma and Lymphoma Non-Hodgkin, run by Carrie Ho, MD at 2 sites 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 44 inclusion and 21 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact UCSF Hematopoietic Malignancies Clinical Trial Recruitment (877-827-3222, HDFCCC.Heme@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cytokine Release Syndrome (CRS) Rate (time frame: Up to day 42). 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 NCT07588698.

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 1 Oct 2026.

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