A Randomized, Open-Label, Multicenter, Global, Phase 2 Trial to Evaluate the Efficacy and Safety of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) as Monotherapy or in Combination with Lenalidomide as First-Line Therapy for Anthracycline-Ineligible Subjects with Diffuse Large B-Cell Lymphoma

Conditions

DIFFUSE LARGE B CELL LYMPHOMA

Brief summary

Complete response (CR) rate determined by Lugano criteria

Detailed description

Duration of response (DOR) determined by Lugano criteria, Duration of complete response (DOCR) determined by Lugano criteria, Time to response (TTR) determined by Lugano criteria, Overall response rate (ORR) determined by Lugano criteria, Progression-free survival (PFS) determined by Lugano criteria, Time to next (anti-lymphoma) therapy (TTNT)., Rate and duration of minimal residual disease (MRD) negative status, Overall survival (OS), Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incidence of antidrug antibodies (ADAs) to epcoritamab, PK parameters (clearance, volume of distribution, area under-the- concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and halflife [t½]), Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)

Related papers

No related papers found yet.

Interventions

DRUGDIPHENHYDRAMINE

DRUGEpcoritamab

DRUGTOCILIZUMAB

DRUGDEXAMETHASONE

DRUGANAKINRA

DRUGPARACETAMOL

DRUGSILTUXIMAB

DRUGLENALIDOMIDE

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete response (CR) rate determined by Lugano criteria	—

Secondary

Measure	Time frame
Duration of response (DOR) determined by Lugano criteria, Duration of complete response (DOCR) determined by Lugano criteria, Time to response (TTR) determined by Lugano criteria, Overall response rate (ORR) determined by Lugano criteria, Progression-free survival (PFS) determined by Lugano criteria, Time to next (anti-lymphoma) therapy (TTNT)., Rate and duration of minimal residual disease (MRD) negative status, Overall survival (OS), Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incidence of antidrug antibodies (ADAs) to epcoritamab, PK parameters (clearance, volume of distribution, area under-the- concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and halflife [t½]), Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)	—

Measure

Time frame

Duration of response (DOR) determined by Lugano criteria, Duration of complete response (DOCR) determined by Lugano criteria, Time to response (TTR) determined by Lugano criteria, Overall response rate (ORR) determined by Lugano criteria, Progression-free survival (PFS) determined by Lugano criteria, Time to next (anti-lymphoma) therapy (TTNT)., Rate and duration of minimal residual disease (MRD) negative status, Overall survival (OS), Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incidence of antidrug antibodies (ADAs) to epcoritamab, PK parameters (clearance, volume of distribution, area under-the- concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and halflife [t½]), Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)

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Countries

Austria, Belgium, Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed