BiFAST : A phase II trial evaluating fixed dose and faster ramp-up of epcoritamab with lenalidomide for 3L relapse/refractory large B-cell lymphoma after CAR T-cells therapy in 2nd line

Condition studied

3L relapse/refractory large B-cell lymphoma after CAR T-cells therapy in 2nd line

Investigational medicinal product(s)

Eligibility

Primary endpoint

Overall response rate (ORR) after C2, or at PTD whichever occurs first, according to the 2014 Lugano Response Criteria determined by investigator assessment.

Endpoint detail

Best ORR according to the 2014 Lugano Response Criteria determined by investigator assessment during treatment, Complete metabolic response rate after C1, C2, C5, C8 and at the end of treatment according to the 2014 Lugano Response Criteria determined by investigator assessment, Duration of response (DoR), defined from the time of attainment of first CMR or PMR (according to Lugano criteria) to the date of first documented disease progression, relapse or death from any cause, Duration of complete response (DoCR), defined from the time to attainment of first CMR (according to Lugano criteria) to the date of first documented disease progression, relapse or death from any cause, Progression-free survival (PFS), Overall survival (OS), Safety endpoints: TLS, ICANS, CRS, Cytopenia, infections