OncoMatch/Clinical Trials/NCT06796998
Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)
Is NCT06796998 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Epcoritamab for marginal zone lymphoma.
Treatment: Epcoritamab — The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer therapy
Exception: localized therapy (e.g., radiation or surgery) without systemic therapy and recurrent disease; H. pylori-positive gastric EMZL treated with antibiotics and histologically confirmed MZL
Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization)
Cannot have received: allogeneic stem cell transplant
Allogeneic stem cell transplant or autologous stem cell transplant or chimeric antigen receptor (CAR) T-cell therapy for any indication
Cannot have received: autologous stem cell transplant
Allogeneic stem cell transplant or autologous stem cell transplant or chimeric antigen receptor (CAR) T-cell therapy for any indication
Cannot have received: CAR-T cell therapy
Allogeneic stem cell transplant or autologous stem cell transplant or chimeric antigen receptor (CAR) T-cell therapy for any indication
Lab requirements
Blood counts
ANC ≥1.0 × 10^9 cells/L; Hemoglobin ≥8.0 g/dL; Platelet count ≥50 × 10^9 platelets/L
Kidney function
Creatinine within normal institutional limits, or calculated creatinine clearance ≥35 mL/min by Cockcroft-Gault Equation; eGFR ≥30 mL/min/1.73 m2 using MDRD formula for participants with creatinine levels above institutional normal (unless due to lymphoma)
Liver function
Total bilirubin ≤1.5 × ULN unless Gilbert's syndrome or non-hepatic origin or lymphoma involvement of the liver and total bilirubin if ≤5 x ULN; ALT/AST ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma
Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors): Absolute neutrophil count (ANC) ≥1.0 × 10^9 cells/L. Hemoglobin ≥8.0 g/dL. Platelet count ≥50 × 10^9 platelets/L. 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. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma. Creatinine within normal institutional limits, or 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
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