Actively Recruiting
Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab
Led by The Lymphoma Academic Research Organisation · Updated on 2026-03-16
60
Participants Needed
13
Research Sites
223 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or their legal representative understands and signs informed consent before any study procedure.
- Age 18 years or older at the time of consent.
- Confirmed diagnosis of primary diffuse large B-cell lymphoma of the CNS or primary vitreoretinal diffuse large B-cell lymphoma with CD20 positivity.
- Relapsed or refractory PCNSL or PVRL after at least one line of systemic therapy, including high-dose methotrexate.
- ECOG performance status of 0 to 2.
- Estimated life expectancy of at least 2 months.
- Evaluable disease on brain MRI for PCNSL subjects.
- Able to swallow capsules (no stomach tube).
- Adequate blood counts: neutrophils ≥ 1.0 G/L without G-CSF for 7 days, platelets ≥ 50 G/L without transfusion for 7 days, hemoglobin ≥ 8.0 g/dL without transfusion for 7 days.
- Adequate kidney function: creatinine clearance > 40 ml/min (dose adjustment if 40-60 ml/min).
- Adequate liver function: bilirubin ≤ 2.0 mg/dl (unless Gilbert's syndrome) and AST or ALT ≤ 3 times upper normal limit.
- Able to understand teratogenic risks of lenalidomide treatment.
- Women of childbearing potential must agree to use two reliable contraception methods or abstain during specified periods including before, during, and after treatment.
- Women of childbearing potential must have negative pregnancy tests at screening and before each treatment cycle.
- Women must agree not to donate eggs during the study until 12 months after treatment ends.
- Men sexually active with women of reproductive potential must use effective contraception and agree not to donate sperm during and after treatment for specified periods.
- Covered by any French social security system.
- Understand and speak an official country language or have authorized translator.
You will not qualify if you...
- Diagnosis of T-cell lymphoma.
- Cerebral involvement from systemic lymphoma.
- Prior organ transplantation or severe immunodeficiency.
- Known HIV or positive HTLV1 infection.
- Active hepatitis B or C infection; prior HBV with negative PCR allowed with antiviral therapy.
- Persistent SARS-CoV-2 infection without symptom resolution and negative PCR.
- Unable to follow study schedule due to geographic, social, or psychological reasons.
- Active cancer other than the study lymphoma, except certain treated or non-invasive cancers.
- Known allergy to study drugs or components.
- Previous CAR-T therapy within 30 days before enrollment.
- Receiving immunosuppressive therapy above specified limits unless for lymphoma control.
- Prior use of bispecific antibodies targeting CD3/CD20 or lenalidomide.
- Seizure disorder requiring treatment unless caused by lymphoma.
- Recent live vaccinations within 28 days, except authorized COVID-19 vaccines.
- Anti-cancer therapy within 28 days before study treatment.
- Major surgery within 4 weeks before enrollment.
- Significant cardiovascular disease or recent stroke.
- QTcF interval >470 ms on ECG.
- Active infections requiring systemic treatment.
- Contraindications to uric acid-lowering agents.
- Significant liver disease or active alcohol abuse.
- Active or recent tuberculosis treatment.
- Receiving immunostimulatory agents.
- Prior allogeneic stem cell transplantation.
- Medical or psychiatric conditions interfering with study participation.
- Subject deprived of liberty or hospitalized without consent.
- Adult under legal protection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
INSTITUT BERGONIE - Service d'Oncologie Médicale
Bordeaux, France
Active, Not Recruiting
2
INSTITUT D'HEMATOLOGIE DE BASSE NORMANDIE - Service Hématologie
Caen, France
Actively Recruiting
3
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, France
Actively Recruiting
4
CHU DE LILLE - HOPITAL CLAUDE HURIEZ - Service des Maladies du Sang
Lille, France
Actively Recruiting
5
CHR DE MARSEILLE - CHU TIMONE - Service de Neuro-Oncologie
Marseille, France
Active, Not Recruiting
6
CHRU DE NANCY - HOPITAL CENTRAL - Service de Neurologie
Nancy, France
Active, Not Recruiting
7
GHU PITIE-SALPETRIERE - CHARLES FOIX - Service Neurologie
Paris, France
Active, Not Recruiting
8
HOPITAL DE LA PITIE SALPETRIERE - Service Hématologie Clinique
Paris, France
Active, Not Recruiting
9
CHU LYON-SUD - Hématologie Clinique
Pierre-Bénite, France
Actively Recruiting
10
CHU PONTCHAILLOU - Hématologie Clinique
Rennes, France
Not Yet Recruiting
11
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
Saint-Cloud, France
Active, Not Recruiting
12
IUCT ONCOPOLE - Service Hématologie
Toulouse, France
Actively Recruiting
13
CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
Tours, France
Active, Not Recruiting
Research Team
P
Project Management
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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