Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) (NCT06796998) | Clinical Trial Compass
RecruitingPhase 2
Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)
United States25 participantsStarted 2025-10-13
Plain-language summary
The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women aged 18 years or older at the time of signing informed consent.
✓. Able and willing to sign the informed consent form (ICF).
✓. Ability to comply with the trial protocol.
✓. Histologically confirmed Marginal Zone Lymphoma (MZL) of Extranodal Marginal Zone Lymphoma (EMZL), Nodal Marginal Zone Lymphoma (NMZL) and Splenic Marginal Zone Lymphoma (SMZL) subtypes presenting with stage I-IV disease.
✓. Previously untreated participants.
✓. Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, participant has histologically confirmed MZL.
✓. Participants who were previously treated with localized therapy (eg, radiation or surgery) and never received systemic therapy and present with recurrent disease are eligible upon histological confirmation of MZL.
✓. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures \>1.5 cm in the longest diameter (LDi) and ≥1.0 cm in the longest perpendicular diameter as assessed by PET/CT, CT or MRI, especially in extranodal sites, per response criteria for lymphomas (Cheson, et al., 2014). Imaging must be conducted within 6 weeks prior to the start of therapy.
Exclusion criteria
✕. Participant should have at least one of the following criteria for treatment initiation:
✕0. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
✕1. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
✕. Total bilirubin ≤1.5 × upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin if ≤5 x ULN.