Not recruitingRare disease

Study on the Safety of Epcoritamab for Children and Young Adults with Relapsed or Refractory Aggressive B-cell Lymphomas

Verified siteInvestigationalNo placebo

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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 cancer known as Relapsed/Refractory Aggressive Mature B-cell Neoplasms, which includes specific subtypes like Burkitt's lymphoma, Burkitt-like lymphoma, and Diffuse Large B-cell Lymphoma (DLBCL). These are aggressive forms of cancer that affect a type of white blood cell called B-cells. The study is testing a new treatment called Epcoritamab (GEN3013), which is a type of medicine known as a bispecific antibody. This medicine is given as a solution for injection under the skin.

The purpose of the study is to evaluate the safety and how the body processes Epcoritamab in children and young adults who have these types of B-cell cancers and have not responded to previous treatments. Participants in the study will receive the medication and be monitored for any side effects and how well the treatment is tolerated. The study will also look at how the medicine moves through and affects the body.

Throughout the study, researchers will observe participants for any serious side effects, such as Cytokine Release Syndrome (CRS), which is a reaction that can occur when the immune system is activated, and Immune Cell-Associated Neurotoxicity Syndrome (ICANS), which affects the nervous system. The study will also track how long participants live without the cancer getting worse, their overall survival, and the possibility of needing further treatments like stem cell transplants or CAR-T cell therapy. The study aims to provide valuable information about the potential benefits and risks of using Epcoritamab for treating these aggressive cancers in young patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient or their legal representative must provide informed consent. This involves understanding the study's purpose and agreeing to participate.
The patient must be between 1 and 18 years old, or up to 25 years old if diagnosed with specific types of lymphoma or leukemia.
Step 2
Initial assessment
An initial assessment is conducted to confirm the patient's eligibility. This includes verifying the diagnosis of relapsed or refractory aggressive mature B-cell neoplasms.
The patient must be able to tolerate subcutaneous injections and have adequate bone marrow, liver, and kidney function.
Step 3
Treatment administration
The patient receives epcoritamab as a solution for injection. This medication is administered subcutaneously, meaning it is injected under the skin.
The dosage and frequency of administration are determined by the study protocol and the patient's specific condition.
Step 4
Monitoring and evaluation
Throughout the study, the patient is monitored for safety and tolerability. This includes checking for any adverse effects such as Cytokine Release Syndrome (CRS) or Immune Cell-Associated Neurotoxicity Syndrome (ICANS).
The effectiveness of the treatment is evaluated using criteria specific to pediatric non-Hodgkin lymphoma.
Step 5
Follow-up
The study includes follow-up assessments to track the patient's overall response to the treatment, event-free survival, and overall survival.
The duration of the response and any potential need for further treatments, such as stem cell transplantation or CAR-T therapy, are also evaluated.

Who can join the trial?

8 criteria

The patient or their legal representative must sign a consent form before any study procedures begin. If the patient is too young to consent, a parent or guardian must provide consent, and the patient should agree if they are old enough.
The patient must be between 1 and 18 years old at the time of their primary diagnosis. Patients up to 25 years old with specific types of lymphoma or leukemia are also eligible.
The patient must be able to handle injections under the skin.
The disease must be confirmed through testing of tumor tissue.
The patient must have a disease that has returned or not responded to treatment, meeting specific criteria related to their response to previous therapies.
The patient must have recovered from the side effects of previous treatments.
The patient must have a performance status score that indicates they are well enough to participate. This is measured by specific scales: Lansky for those under 16, Karnofsky for those 16 and older, or ECOG score.
The patient must have adequate bone marrow, liver, and kidney function.

Who cannot join the trial?

4 criteria

Patients who have not experienced a return of their disease or whose disease is not resistant to treatment.
Patients who have not been diagnosed with aggressive mature B-cell neoplasms, which are a type of cancer affecting certain white blood cells.
Patients who have successfully reached remission, meaning their disease is under control, with re-induction therapy, which is a treatment given after the disease returns.
Patients who are able to receive further consolidation with cell therapy, which is a treatment that helps strengthen the effects of previous cancer treatments.

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Verified sites

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

Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Epcoritamab is a medication being studied for its safety and how it behaves in the body when used alone in children and young adults. It is being tested in patients who have certain types of aggressive B-cell lymphomas or leukemias, such as Burkitt's lymphoma or diffuse large B-cell lymphoma, that have come back or have not responded to previous treatments. The goal is to see if this medication can help patients who have not been able to achieve remission with other therapies.

Epcoritamab

What is already known about the treatment

Epcoritamab – Epcoritamab is administered as an injection under the skin, known as a subcutaneous injection. It is currently being studied in clinical trials, particularly for its safety and how it behaves in the body, in pediatric patients with certain aggressive B-cell cancers that have not responded to other treatments. The main therapeutic use of Epcoritamab is for treating relapsed or refractory aggressive mature B-cell neoplasms, including specific types like Burkitt's lymphoma and diffuse large B-cell lymphoma. At the molecular level, Epcoritamab works by targeting and binding to CD20, a protein found on the surface of B-cells, helping the immune system to recognize and destroy these cancerous cells. It is classified as a bispecific antibody, which means it can bind to two different types of antigens, enhancing its ability to target cancer cells effectively.

Investigated diseases

Relapsed/Refractory Aggressive Mature B-cell Neoplasms – This group of diseases includes various types of aggressive B-cell lymphomas and leukemias, such as Burkitt's lymphoma and diffuse large B-cell lymphoma (DLBCL). These conditions are characterized by the uncontrolled growth of mature B-cells, a type of white blood cell, which can form tumors in lymph nodes and other organs. The term "relapsed" refers to the return of the disease after treatment, while "refractory" indicates that the disease does not respond to standard treatments. These neoplasms can progress rapidly, leading to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can spread to other parts of the body, including the bone marrow and central nervous system.