RecruitingPHASE2INTERVENTIONAL

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

This research is looking at a new treatment for a specific type of brain cancer called Primary CNS Lymphoma (PCNSL). PCNSL is a challenging condition, especially when it comes back or doesn't get better with standard treatments. This study will focus on patients for whom previous treatments haven't worked or whose cancer has returned. The new drug, epcoritamab, will be given alongside an existing combination of medicines called rituximab and lenalidomide. Researchers want to find out if adding epcoritamab is safe and effective in treating PCNSL, hoping it can improve the chances of recovery and overall health for people with this condition. This is a Phase 2 study, meaning it's exploring whether the treatment works and is safe in a larger group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

The Lymphoma Academic Research Organisation

Enrolment target

Start

22 Sep 2025

Estimated completion

01 Jan 2030

Primary CNS Lymphoma (PCNSL)

What is this study about?

This study is investigating a new approach to treating a type of cancer called Primary Central Nervous System Lymphoma (PCNSL). This is a lymphoma that starts in the brain or spinal cord. When PCNSL comes back after treatment or doesn't respond to standard treatments, it can be particularly difficult to manage. This trial is specifically for people in this situation, where their PCNSL is considered 'relapsed' (it has returned) or 'refractory' (it hasn't responded well to previous treatments).

The main idea behind this study is to see if a new drug called epcoritamab can improve the treatment for PCNSL. Epcoritamab will be added to a treatment plan that already includes two other medicines, rituximab and lenalidomide, which have shown promising results in similar situations. The researchers believe that epcoritamab, which has worked well in another type of lymphoma, might further boost the immune system's ability to fight the cancer when combined with these existing drugs.

By taking part, individuals would be helping doctors understand if this new combination of treatments is both safe and more effective than current options for people with this challenging form of PCNSL. The ultimate goal is to find improved ways to help patients live longer and have a better quality of life.

Key takeaways

This study is for adults with PCNSL that has come back or not responded to previous treatments.
It tests a new drug, epcoritamab, combined with standard treatments lenalidomide and rituximab.
The goal is to find out if this new combination is safe and more effective.
Participation involves regular clinic visits, tests, and taking study medications.
There are potential benefits (new treatment) and risks (side effects).
You can discuss with your doctor if this study is right for you.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. You must have a confirmed diagnosis of Primary CNS Lymphoma (PCNSL) or a related condition called Primary Vitreoretinal Lymphoma, which affects the eyes. Importantly, your cancer must have either come back after treatment or not responded well to at least one previous treatment. For PCNSL, you should have already received a high-dose treatment called methotrexate.

Alongside your diagnosis, doctors will check your overall health and how well your body systems are working. This includes ensuring your blood counts (like red blood cells, white blood cells, and platelets), kidney function, and liver function are within certain healthy limits. You also need to be able to swallow capsules, as this is how one of the medications is given.

Unfortunately, not everyone can join. For instance, if your general health is not good enough, or if other medical conditions might make the study treatment unsafe for you, you might not be able to participate. The study team will carefully review all your medical information to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of PCNSL (brain lymphoma) or a related eye lymphoma?
Has your lymphoma come back or not responded to previous treatments?
Can you swallow capsules?
Is your general health, blood counts, kidney, and liver function generally good?
Have you previously received methotrexate treatment for your lymphoma?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new treatment, epcoritamab, alongside two other approved medications, rituximab and lenalidomide. You will have regular visits to the clinic for medical check-ups, blood tests, and scans (like MRI brain scans) to monitor your health and how the treatment is working. These visits will be more frequent at the beginning and then become less frequent over time.

The study treatment involves infusions (given into a vein) of epcoritamab and rituximab, and taking lenalidomide capsules by mouth. The exact schedule for these will be explained in detail by the study team. You will be closely monitored for any side effects or changes in your condition. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing follow-up to track your health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that could be more effective for your PCNSL than available options, especially if your cancer has been difficult to treat. However, there's no guarantee the treatment will work for you. Potential risks include experiencing side effects from the study medications, which can range from mild to serious, and the inconvenience of extra hospital visits and tests. You have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (13)

INSTITUT BERGONIE - Service d'Oncologie Médicale
Verified postcode
Bordeaux, France· Active not recruiting
INSTITUT D'HEMATOLOGIE DE BASSE NORMANDIE - Service Hématologie
Verified postcode
Caen, France· Recruiting
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU DE LILLE - HOPITAL CLAUDE HURIEZ - Service des Maladies du Sang
Verified postcode
Lille, France· Recruiting
CHR DE MARSEILLE - CHU TIMONE - Service de Neuro-Oncologie
Verified postcode
Marseille, France· Active not recruiting
CHRU DE NANCY - HOPITAL CENTRAL - Service de Neurologie
Verified postcode
Nancy, France· Active not recruiting
GHU PITIE-SALPETRIERE - CHARLES FOIX - Service Neurologie
Verified postcode
Paris, France· Active not recruiting
HOPITAL DE LA PITIE SALPETRIERE - Service Hématologie Clinique
Verified postcode
Paris, France· Active not recruiting
CHU LYON-SUD - Hématologie Clinique
Verified postcode
Pierre-Bénite, France· Recruiting
CHU PONTCHAILLOU - Hématologie Clinique
Verified postcode
Rennes, France· Not yet recruiting
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
Verified postcode
Saint-Cloud, France· Active not recruiting
IUCT ONCOPOLE - Service Hématologie
Verified postcode
Toulouse, France· Recruiting

Common questions

What is Primary CNS Lymphoma (PCNSL)?

It's a rare type of cancer that starts in the brain, spinal cord, or eyes.

What does 'relapsed or refractory' mean?

It means the cancer has come back after treatment, or it didn't respond well to previous treatments.

What is epcoritamab?

It's a new drug being tested to help the immune system fight cancer cells.

Why combine epcoritamab with other drugs?

Researchers hope that adding epcoritamab to existing treatments will make the overall treatment more effective.

How long will the study last for each person?

The duration varies, depending on your response to treatment and the study plan, but includes ongoing monitoring.

How to find out more

Project Management

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

Always speak to your GP or specialist before deciding to take part in a study.