A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Conditions

B-cell Lymphoma

Brief summary

Overall survival (OS), Progression-free survival (PFS) determined by Lugano criteria per independent review committee (IRC) assessment

Detailed description

Progression-free survival (PFS) determined by Lugano criteria per investigator assessment, Overall response rate (ORR) determined by Lugano criteria per IRC assessment and investigator assessment, Complete response (CR) rate determined by Lugano criteria per IRC assessment and investigator assessment, Duration of response (DOR) determined by Lugano criteria per IRC assessment and investigator assessment, Time to response (TTR) determined by Lugano criteria per IRC assessment and investigator, Rate and duration of minimal residual disease (MRD) negative status, PFS determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) per IRC assessment, ORR determined by LYRIC per IRC assessment, CR rate determined by LYRIC per IRC assessment, DOR determined by LYRIC per IRC assessment, TTR determined by LYRIC per IRC assessment, Time to next anti-lymphoma therapy (TTNT), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incidence of dose interruptions and delays, Anti-epcoritamab antibody response, Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)

Related papers

No related papers found yet.

Interventions

DRUGDEXAMETHASONE

DRUGSILTUXIMAB

DRUGEpcoritamab

DRUGTOCILIZUMAB

DRUGOXALIPLATIN

DRUGPARACETAMOL

DRUGBENDAMUSTINE

DRUGRITUXIMAB

DRUGANAKINRA

DRUGDIPHENHYDRAMINE

DRUGGEMCITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS) determined by Lugano criteria per independent review committee (IRC) assessment	—

Secondary

Measure	Time frame
Progression-free survival (PFS) determined by Lugano criteria per investigator assessment, Overall response rate (ORR) determined by Lugano criteria per IRC assessment and investigator assessment, Complete response (CR) rate determined by Lugano criteria per IRC assessment and investigator assessment, Duration of response (DOR) determined by Lugano criteria per IRC assessment and investigator assessment, Time to response (TTR) determined by Lugano criteria per IRC assessment and investigator, Rate and duration of minimal residual disease (MRD) negative status, PFS determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) per IRC assessment, ORR determined by LYRIC per IRC assessment, CR rate determined by LYRIC per IRC assessment, DOR determined by LYRIC per IRC assessment, TTR determined by LYRIC per IRC assessment, Time to next anti-lymphoma therapy (TTNT), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incid	—

Measure

Time frame

Progression-free survival (PFS) determined by Lugano criteria per investigator assessment, Overall response rate (ORR) determined by Lugano criteria per IRC assessment and investigator assessment, Complete response (CR) rate determined by Lugano criteria per IRC assessment and investigator assessment, Duration of response (DOR) determined by Lugano criteria per IRC assessment and investigator assessment, Time to response (TTR) determined by Lugano criteria per IRC assessment and investigator, Rate and duration of minimal residual disease (MRD) negative status, PFS determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) per IRC assessment, ORR determined by LYRIC per IRC assessment, CR rate determined by LYRIC per IRC assessment, DOR determined by LYRIC per IRC assessment, TTR determined by LYRIC per IRC assessment, Time to next anti-lymphoma therapy (TTNT), Incidence and severity of adverse events (AEs), Incidence and severity of changes in laboratory values, Incid

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Countries

Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed