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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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 trial?

18 criteria

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 trial?

9 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France

Trial locations

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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.

What is already known about the treatment

Epcoritamab
This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating relapsed and refractory primary diffuse large B-cell lymphoma of the central nervous system (CNS). It is a promising treatment option being evaluated for its ability to improve response rates in patients who have not responded to other therapies. Epcoritamab works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, a type of targeted therapy designed to interfere with cancer cell growth.
Lenalidomide
This medication is taken orally in the form of capsules and is used in combination with other treatments for certain types of cancer, including relapsed and refractory primary diffuse large B-cell lymphoma of the CNS. It is well-established in medical literature as an immunomodulatory agent that helps enhance the immune system's ability to fight cancer. Lenalidomide works by affecting the immune system and inhibiting the growth of cancer cells. It belongs to a class of drugs known as immunomodulatory agents.
Rituximab
Administered through intravenous infusion, Rituximab is a well-known medication used in the treatment of various types of lymphoma, including relapsed and refractory primary diffuse large B-cell lymphoma of the CNS. It is widely recognized in medical literature for its role in targeting and destroying specific cancer cells. Rituximab works by binding to a protein called CD20 found on the surface of B-cells, leading to the destruction of these cells. It is classified as a monoclonal antibody, which is a type of targeted therapy.

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.