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

Conditions

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

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGEpcoritamab (GEN3013)

DRUGLENALIDOMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed