e-REVRI - A Phase 2 Study evaluating Epcoritamab in subjects with relapsed and refractory primary diffuse large B-cell lymphoma of the CNS treated with Lenalidomide and Rituximab

Conditions

relapsed and refractory primary diffuse large B-cell lymphoma of the CNS

Brief summary

The primary endpoint is the best Objective Response rate (ORR) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) as determined by central review according to the International group for primary CNS lymphoma (IPCG) recommendations in the R/R PCNSL cohort.

Detailed description

Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation according to IPCG recommendations as determined by investigator assessment, Best objective response rate (CR + CRu + PR) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) in the PVRL cohort according to the IPCG recommendations by investigator assessment, Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation in the PVRL cohort according to the IPCG recommendations by investigator assessment, Best complete response rate (CR+CRu) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) according to the IPCG recommendations as determined by investigator assessment, Time to objective response (TTR) according to IPCG recommendations, Progression-free survival (PFS) according to IPCG recommendations, Duration of response (DOR) according to IPCG recommendations, Overall Survival (OS), Time to next treatment (TTNT)

Related papers

No related papers found yet.

Interventions

DRUGRITUXIMAB

DRUGLENALIDOMIDE

DRUGEPCORITAMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the best Objective Response rate (ORR) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) as determined by central review according to the International group for primary CNS lymphoma (IPCG) recommendations in the R/R PCNSL cohort.	—

Secondary

Measure	Time frame
Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation according to IPCG recommendations as determined by investigator assessment, Best objective response rate (CR + CRu + PR) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) in the PVRL cohort according to the IPCG recommendations by investigator assessment, Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation in the PVRL cohort according to the IPCG recommendations by investigator assessment, Best complete response rate (CR+CRu) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) according to the IPCG recommendations as determined by investigator assessment, Time to objective response (TTR) according to IPCG recommendations, Progression-free survival (PFS) according to IPCG recommendations, Duration of	—

Measure

Time frame

Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation according to IPCG recommendations as determined by investigator assessment, Best objective response rate (CR + CRu + PR) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) in the PVRL cohort according to the IPCG recommendations by investigator assessment, Objective response rate (CR + CRu + PR) after 8 cycles of study treatment or at permanent treatment discontinuation in the PVRL cohort according to the IPCG recommendations by investigator assessment, Best complete response rate (CR+CRu) during the first 8 cycles corresponding to the induction phase (or at permanent treatment discontinuation) according to the IPCG recommendations as determined by investigator assessment, Time to objective response (TTR) according to IPCG recommendations, Progression-free survival (PFS) according to IPCG recommendations, Duration of

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Countries

France

Outcome results

None listed