Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT06931652
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary CNS Lymphoma (PCNSL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Epcoritamab Investigational Medicinal Product (IMP): Epcoritamab will be used during induction phase and Maintenance phase.

Study Details

The purpose of this phase 2 study is to evaluate the efficacy and safety of epcoritamab in subjects with relapsed or refractory primary diffuse large B-cell lymphoma of the Central Nervous System treated with rituximab and lenalidomide.

Key Dates

Start date
Sep 22, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental/epcoritamab
    Investigational Medicinal Product (IMP): Epcoritamab will be used during induction phase and Maintenance phase. Auxiliary Medicinal Products (AMP): Rituximab and Lenalidomide Standard use for AMP is: Induction: At cycle 1: Rituximab IV 375mg/m2 Day 1, 8, 15, 22; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 2-3: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 4-8: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 Maintenance: At cycle 9-20: Day 1: Lenalidomide 20mg oral route Day 1-D21 (12 cycles corresponding to one year of maintenance treatment)

Primary Outcome Measure

The best Objective Response rate (ORR) in the R/R PCNSL cohort [ Time Frame: after 8 months or before in case of permanent treatment discontinuation ]

Central Contacts