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

RECRUITINGPHASE2

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

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

NCT06931652•The Lymphoma Academic Research Organisation

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Primary CNS DLBCL has an altered prognostic compared to systemic DLBCL mostly due to an increased relapse rate. PCNSL patients for whom the global prognostic remains poor, calling for improved treatment at relapse. Considering the good results of R2 regimen in R/R PCNSL and the efficacy and favorable safety profile of epcoritamab in R/R systemic DLBCL, the addition of Epcoritamab to the combination of R2 might significantly improve the prognosis of PCNSL patients at relapse. In addition, it is expected that IMiDs could potentially increase the efficiency of epcoritamab by stimulating the immune system.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject (or their legally acceptable representative/trusted person) who understand and voluntarily signs and dates an informed consent form prior to any study-specific assessments/procedures being conducted.
•2. Subject ≥ 18 years old at the time of signing the informed consent form (ICF)
•3. Confirmed histology of primary diffuse large B-cell lymphoma of the CNS (according to the 2022 WHO classification) or confirmed cytology of primary vitreoretinal diffuse large B-cell lymphoma, with CD20 positivity in immunohistochemical staining or flow cytometry at any point in the disease history.
•4. Subjects with relapsed or refractory (R/R) PCNSL or PVRL after at least one line of systemic therapy. Subject with R/R PCNSL must have previously received at least high dose methotrexate. Subject with R/R PVRL must have received either intravenous high dose methotrexate or intraocular methotrexate (PVRL cohort). Subjects can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or PVRL.
•5. ECOG performance status 0 to 2.
•6. Estimated minimum life expectancy of ≥ 2 months.
•7. R/R PCNSL subjects with evaluable disease on brain MRI.
•8. Able to swallow capsules (stomach tube not allowed)
•9. Adequate hematopoietic function:
•* Absolute neutrophil count of ≥ 1.0 G/L without G-CSF support for at least 7 days before screening
+11 more criteria

Exclusion Criteria

•Subject who meets any of the following criteria should be excluded from enrollment in the study:
•1. T-cell lymphoma.
•2. Cerebral localization of a systemic lymphoma.
•3. Prior history of organ transplantation or other cause of severe immunodeficiency.
•4. Known Human Immunodeficiency Virus (HIV) or Positive HTLV1 serology.
•5. Active Hepatitis B Virus (HBV) infection (DNA PCR-positive) or active hepatitis C Virus (HCV) infection (RNA PCR-positive). Subjects with evidence of prior HBV infection but who are PCR-negative are permitted in the study but should receive prophylactic antiviral therapy. Subjects who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.
•6. Persistent SARS-CoV-2 infection. Subjects who have had or currently have a SARS-CoV-2 infection must demonstrate symptom resolution and provide a negative nasopharyngeal PCR test at time of inclusion. Both of these requirements must be met for the subject to be considered clear of the virus.
•7. Impossibility to follow the calendar of exams because of geographic, social, or psychological reasons.
•8. Active malignancy other than the one treated in this Study. Prior history of malignancies (other than inclusion diagnosis) unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history/concurrent conditions are allowed:
•1. Non-invasive basal cell or epidermoid carcinoma
+27 more criteria

Locations (13)

INSTITUT BERGONIE - Service d'Oncologie Médicale

Bordeaux, France

INSTITUT D'HEMATOLOGIE DE BASSE NORMANDIE - Service Hématologie

Caen, France

CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique

Clermont-Ferrand, France

CHU DE LILLE - HOPITAL CLAUDE HURIEZ - Service des Maladies du Sang

Lille, France

CHR DE MARSEILLE - CHU TIMONE - Service de Neuro-Oncologie

Marseille, France

CHRU DE NANCY - HOPITAL CENTRAL - Service de Neurologie

Nancy, France

GHU PITIE-SALPETRIERE - CHARLES FOIX - Service Neurologie

Paris, France

HOPITAL DE LA PITIE SALPETRIERE - Service Hématologie Clinique

Paris, France

CHU LYON-SUD - Hématologie Clinique

Pierre-Bénite, France

CHU PONTCHAILLOU - Hématologie Clinique

Rennes, France

Key Dates

Start Date

September 22, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2030

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Primary CNS Lymphoma (PCNSL)

Interventions

Epcoritamab

DRUG

Contacts

Project Management

CONTACT

04 72 66 93 33 e-revri@lysarc.org