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Epcoritamab for Newly Diagnosed Marginal Zone Lymphoma

This study is looking into a treatment called Epcoritamab for people newly diagnosed with Marginal Zone Lymphoma (MZL), a type of slow-growing non-Hodgkin lymphoma. Epcoritamab is given as shots under the skin, with the dose gradually increasing at first. The study aims to see if Epcoritamab can lead to a complete response (meaning all signs of cancer disappear) within 12 months. You might be able to join if you are 18 or older and have a confirmed diagnosis of Extranodal, Nodal, or Splenic Marginal Zone Lymphoma. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This study is testing Epcoritamab in 25 participants with Marginal Zone Lymphoma. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures a complete response at 12 months, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06796998

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Izidore Lossos, MD
~25 participants
Updated 2025-10-28 on ClinicalTrials.gov
What's tested:Epcoritamab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Response (CR)
Measured over 12 months

Conditions

Marginal Zone Lymphoma
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Splenic Marginal Zone Lymphoma
Nodal Marginal Zone Lymphoma

Explore related trials

Extranodal Marginal Zone LymphomaNodal Marginal Zone LymphomaSplenic Marginal Zone Lymphoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Izidore Lossos, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Izidore Lossos, MD
[email protected]
+1 (305) 2434787
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Threatened extranodal organ function, especially for extranodal MZL
Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
Any nodal or extranodal tumor mass with a diameter of ≥5 cm
B symptoms (fever ≥38 degrees Celsius of unclear etiology, night sweats, weight loss \>10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement.
Risk of local compressive symptoms that may result in organ compromise
Splenomegaly \>13 cm or splenic lesion without splenomegaly and needs treatments (e.g., symptoms, cytopenias \[hemoglobin (HgB) \<10 g/dL and platelet count ≤ 80 × 10\^9 platelets/L attributable to lymphoma bone marrow infiltration, splenomegaly or autoimmunity\], \>5,000 lymphoma cells/mm3).
Threatened organ function, especially for extranodal MZL
Leukopenia attributed to MZL (leukocytes \<1,000 cells/mm3)
Leukemia (\>5,000 lymphoma cells/mm3)
Requirement for transfusion or growth factor support attributed to lymphoma
Involvement of 2 or more extranodal sites, with tumor/lesion in each extranodal site ≥1 cm 9. Life expectancy \>3 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 11. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
calculated creatinine clearance ≥35 mL/min by the Cockcroft-Gault Equation (Cockcroft, 1976)
estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula for participants with creatinine levels above institutional normal (unless due to lymphoma) 12. Willingness to avoid pregnancy during the trial and for at least 90 days after the last dose of the trial intervention. For more information on Contraception, please see Section 5.12.
i. Rash must cover 10% of body surface area
ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids
iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months 23. Patient has no known active SARS-CoV-2 infection. If a patient has signs/symptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.
At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms. 24. Patients with impaired decision-making capacity.

What this trial measures

  • Complete Response (CR)12 months

    The proportion of participants achieving a best overall response of complete response (CR) after Cycle 12 of study therapy will be reported. Response will be assessed using modified Cheson criteria, if disease is not fluorodeoxyglucose (FDG)-avid in initial Screening; or by revised Lugano criteria if Screening FDG-positron emission tomography (PET)/ computed tomography (CT) demonstrated FDG avid disease. For Lugano criteria, CR will be defined by a Deauville score of ≤3.