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Study of Epcoritamab, Lenalidomide, and Rituximab for Patients with Relapsed and Refractory Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called relapsed and refractory primary diffuse large B-cell lymphoma of the central nervous system (CNS). This condition occurs when the cancer returns or does not respond to previous treatments. The study will evaluate a new treatment approach using a combination of medications: Epcoritamab, Lenalidomide, and Rituximab. Epcoritamab is given as an injection under the skin, Lenalidomide is taken as a capsule by mouth, and Rituximab is administered through an infusion into a vein.

The purpose of the study is to assess how effective Epcoritamab is when used alongside Lenalidomide and Rituximab in treating this specific type of lymphoma. Participants in the study will receive these medications over a series of treatment cycles. The study will monitor the response of the cancer to the treatment during the initial phase, which consists of eight cycles. The goal is to determine the best response rate, which includes complete or partial reduction of the cancer, as recommended by international guidelines for this type of lymphoma.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI (Magnetic Resonance Imaging), to evaluate the progress of the treatment. The study aims to provide valuable information on the effectiveness of this treatment combination, which could potentially lead to improved outcomes for patients with this challenging form of lymphoma.

1 induction phase

The induction phase consists of 8 cycles of treatment. During this phase, the effectiveness of the treatment is evaluated.

The medications used in this phase include rituximab, lenalidomide, and epcoritamab.

Rituximab is administered through an intravenous infusion. The specific dosage and frequency will be determined by the healthcare provider.

Lenalidomide is taken orally. The dosage may be adjusted based on kidney function.

Epcoritamab is administered subcutaneously. The specific dosage and frequency will be determined by the healthcare provider.

2 evaluation of response

The primary goal is to assess the best objective response rate during the first 8 cycles.

The response is evaluated according to the recommendations of the International group for primary CNS lymphoma.

3 secondary assessments

Secondary assessments include evaluating the objective response rate after 8 cycles or at permanent treatment discontinuation.

Other assessments include time to objective response, progression-free survival, duration of response, overall survival, and time to next treatment.

Who Can Join the Study?

  • The person or their representative must understand and sign a consent form before any study procedures begin.
  • The person must have good kidney function, which means their kidneys can filter waste from the blood properly. This is measured by a test called the Cockcroft-Gault equation, and the result should be more than 40 ml/min.
  • The person must have good liver function, meaning their liver can process substances in the body properly. This is checked by measuring bilirubin and liver enzymes in the blood, which should be within certain limits.
  • The person must understand the risks of the treatment, especially the risk of birth defects from the drug Lenalidomide.
  • Women who can have children must agree to use two reliable forms of birth control or not have sexual contact with men during the study and for a certain time after the study ends. They must also agree not to breastfeed during the study and for a while after.
  • Women must have a negative pregnancy test before starting the study and at the beginning of each treatment cycle.
  • Women must agree not to donate eggs for reproduction during the study and for a certain time after the study ends.
  • Men who are sexually active with women who can have children must use a reliable form of birth control, like a condom, and agree not to donate sperm during the study and for a certain time after.
  • The person must be covered by a social security system if they are in France.
  • The person or their representative must understand and speak one of the official languages of the country, unless a translator is allowed.
  • The person must be at least 18 years old when they sign the consent form.
  • The person must have a confirmed diagnosis of a specific type of lymphoma, which is a cancer of the lymphatic system, in the brain or eyes, and it must show a certain marker called CD20.
  • The person must have lymphoma that has returned or not responded to treatment after at least one previous treatment. They must have received a specific drug called methotrexate before.
  • The person must have a performance status of 0 to 2 on the ECOG scale, which measures how well they can perform daily activities.
  • The person must have an estimated life expectancy of at least 2 months.
  • The person must have lymphoma that can be seen on a brain MRI scan.
  • The person must be able to swallow capsules, as using a stomach tube is not allowed.
  • The person must have good blood cell counts, which means enough white blood cells, platelets, and hemoglobin without recent support from transfusions or medications.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied cannot participate.
  • Patients who have not experienced a return or worsening of their cancer after treatment cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had a recent major surgery or are recovering from surgery cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Arggapseqo Pylqpqtz Hiactzwy Dt Mahiojaeu Marseille France
Ctyydf Hvrukgajgne Rskahnyv Urstjxnwcdtmi Dv Tftqn Tours France
Cdug Dk Ngwup Vandoeuvre Les Nancy France
Iyjgcetz Crwbp Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
30.06.2025

Trial locations

Investigated drugs:

Epcoritamab is a medication being studied for its effectiveness in treating relapsed and refractory primary diffuse large B-cell lymphoma of the central nervous system. It is being evaluated to see how well it works in combination with other treatments.

Lenalidomide is a medication used in this study to help treat the lymphoma. It works by affecting the immune system and may help slow the growth of cancer cells.

Rituximab is another medication used in the trial. It is a type of antibody therapy that targets specific proteins on the surface of cancer cells, helping the immune system to destroy them.

Investigated diseases:

Relapsed and Refractory Primary Diffuse Large B-Cell Lymphoma of the CNS – This is a type of cancer that originates in the lymphatic system and primarily affects the central nervous system, including the brain and spinal cord. It is characterized by the uncontrolled growth of B-cells, a type of white blood cell, which can form tumors in the CNS. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to standard treatments. Symptoms may include headaches, seizures, and neurological deficits depending on the tumor’s location. The progression of the disease can lead to increased neurological impairment as the tumors grow and affect surrounding brain tissue.

Trial ID:
2023-505834-84-00
Protocol code:
e-REVRI
Trial Phase:
Therapeutic use (Phase IV)

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