OncoMatch/Clinical Trials/NCT07126236
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
Is NCT07126236 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Epcoritamab and Epcoritamab, tafasitamab and lenalidomide for large b cell lymphoma.
Treatment: Epcoritamab · Epcoritamab, tafasitamab and lenalidomide — phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) until cycle 15. Patients will be followed up to 5 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody (rituximab, obinutuzumab) — first-line
Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and CHOP (cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) or CHOP-like chemotherapy.
Must have received: cytotoxic chemotherapy (CHOP, CHOP-like) — first-line
Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and CHOP (cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) or CHOP-like chemotherapy.
Cannot have received: autologous stem cell transplant
Previous ASCT
Cannot have received: anti-CD3 and CD20 bispecific antibodies
Prior anti-CD3 and CD20 bispecific antibodies therapy
Cannot have received: anti-CD19 monoclonal antibody (tafasitamab)
prior treatment with tafasitamab
Cannot have received: CAR-T cell therapy
Exception: unless not a candidate or unwilling
patient should not be a candidate for 1st relapse CAR-T therapy or unwilling to receive CAR-T therapy
Lab requirements
Blood counts
Hemoglobin ≥8 g/dl (transfusion support permitted but not within 7 days of screening lab collection); ANC ≥ 1/109/L (growth factor support allowed in case of bone marrow involvement); Absolute lymphocyte count ≥ 0.1/109/L; Platelet count ≥ 70/109/L (unless secondary to bone marrow involvement, OR ≥50x/109/L if documented bone marrow involvement). Platelet transfusions permitted but not within 7 days of screening lab collection.
Kidney function
creatinine clearance calculated by Cockcroft-Gault > 45 ml/min
Liver function
direct bilirubin level < 2 x ULN (except in patients with Gilbert's syndrome), ALT and AST ≤ 3 × ULN or ≤ 5 × ULN in cases of documented liver involvement
Cardiac function
left ventricular ejection fraction (LVEF) > 45%
creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml/min [excluded]; direct bilirubin level < 2 x ULN (except in patients with Gilbert's syndrome), ALT and AST ≤ 3 × ULN or ≤ 5 × ULN in cases of documented liver involvement; Hemoglobin ≥8 g/dl...; LVEF > 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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