Recruiting

Study on Epcoritamab for Patients with Relapsed or Refractory Large B Cell Lymphoma

Verified siteRegistered drugNo 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 called Relapsed/Refractory Large B Cell Lymphoma, which is a condition where the cancer returns or does not respond to treatment. The study aims to evaluate the effectiveness of a treatment called Epcoritamab, which is a medication given as an injection under the skin. Epcoritamab is being tested as a second-line treatment, meaning it is used after the first treatment has not worked. The study will also explore the combination of Epcoritamab with two other medications, Tafasitamab and Lenalidomide. Tafasitamab is a type of protein used in cancer treatment, and Lenalidomide is a capsule taken by mouth.

The purpose of the study is to see how well Epcoritamab works on its own and in combination with Tafasitamab and Lenalidomide in treating patients with this type of lymphoma. Participants in the study will receive Epcoritamab, and some may also receive the combination therapy. The study will monitor the response to these treatments over time, looking at how the cancer responds and how long the response lasts. The study will also assess the safety of these treatments by tracking any side effects experienced by participants.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the treatment. These tests may include imaging scans like PET-CT, which helps doctors see how the cancer is responding to the treatment. The study is designed to adapt based on the responses of participants, meaning the treatment plan may change depending on how well the cancer responds. The study is expected to continue for several years, with the goal of finding more effective treatments for patients with Relapsed/Refractory Large B Cell Lymphoma.

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
Beginning of the trial
Upon joining the study, you will receive a detailed schedule of visits and procedures. It is important to follow this schedule closely to ensure the best possible outcomes.
You will be asked to provide written informed consent, confirming your understanding and agreement to participate in the study.
Step 2
Initial assessments
You will undergo a series of initial assessments to establish your baseline health status. These assessments may include blood tests, imaging scans, and other evaluations as determined by the study team.
Female participants of child-bearing potential will need to take a pregnancy test and agree to use effective contraception methods during the study and for four months after the last dose of study medication.
Step 3
Treatment phase
The treatment phase involves receiving the study medication, epcoritamab, which is administered as a subcutaneous injection. The frequency and duration of these injections will be determined by the study protocol.
In some cases, you may also receive additional medications such as tafasitamab and lenalidomide. Tafasitamab is given as an infusion, while lenalidomide is taken orally in capsule form. The specific dosage and schedule will be provided by the study team.
Step 4
Ongoing monitoring
Throughout the study, you will have regular visits to monitor your health and response to the treatment. This may include physical exams, blood tests, and imaging studies.
You will be asked to report any side effects or changes in your health to the study team promptly.
Step 5
End of treatment
At the end of the treatment phase, you will undergo final assessments to evaluate the effectiveness of the study medication and your overall health status.
You will be provided with information on any follow-up care or additional monitoring that may be necessary after the study concludes.

Who can join the trial?

15 criteria

Must provide written consent to participate in the study.
Women who can have children must have a negative pregnancy test before starting and agree to use highly effective birth control methods during the study and for 4 months after the last dose of the study medication. They must also agree to regular pregnancy testing during the study.
Men must use reliable birth control methods if sexually active with a woman who can have children, during the study and for 4 months after the last dose of the study medication. They must also agree not to donate blood or sperm during the study and for 4 months after.
Women must agree not to donate blood or eggs during the study and for 4 months after the last dose of the study medication.
Women who can have children must not breastfeed during the study and for 4 months after the last dose of the study medication.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and other study procedures.
Must not be participating in another clinical trial or receiving an experimental drug.
Must be over 18 years old.
Must have a confirmed diagnosis of Relapse/Refractory Large B Cell Lymphoma, including types like Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), High-grade B-cell lymphoma (HGBCL), or grade 3B Follicular Lymphoma.
Must have received adequate first-line therapy, including an anti-CD20 monoclonal antibody (like rituximab or obinutuzumab) and CHOP or CHOP-like chemotherapy.
Must not be a candidate for 1st relapse CAR-T therapy or unwilling to receive it. CAR-T therapy is a type of treatment where a patient's T cells are changed in the lab so they will attack cancer cells.
Must be ineligible for autologous stem cell transplantation (ASCT) due to age (65 or older), a high health risk score (HTC-CI of 3 or more), or unwillingness to receive a transplant.
Must have PET positive disease, meaning the disease is active and can be detected by a PET scan, a type of imaging test.
Must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how the disease affects daily living abilities.
Must meet certain blood test values: Hemoglobin of at least 8 g/dl, Absolute Neutrophil Count (ANC) of at least 1 x 10⁹/L, Absolute Lymphocyte Count of at least 0.1 x 10⁹/L, and Platelet Count of at least 70 x 10⁹/L (or 50 x 10⁹/L if there is bone marrow involvement).

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than Relapse/Refractory Large B Cell Lymphoma.
Patients who have received another treatment for their lymphoma within the last 4 weeks.
Patients with uncontrolled or serious infections.
Patients with significant heart problems, such as heart failure or recent heart attack.
Patients with active hepatitis B or C, or HIV infection.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients with a history of another cancer, unless they have been cancer-free for at least 5 years.
Patients who have a known allergy to the study medication or its ingredients.
Patients who are participating in another clinical trial.

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Verified sites

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

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Hospital Costa del Sol
Marbella, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain

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Investigated drugs

Epcoritamab is a type of treatment that helps the body's immune system fight cancer. It is used for patients who have a type of cancer called Large B Cell Lymphoma, especially when the cancer has come back after treatment or has not responded to previous treatments. Epcoritamab works by targeting specific cells in the body that are involved in the growth of cancer, helping to slow down or stop the cancer from growing. This medication is given to patients to see if it can help control their cancer when other treatments have not worked. It is part of a study to understand how effective it is as a second line of treatment for this type of cancer.

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 for its effectiveness in treating patients with a type of cancer called Relapse/Refractory Large B Cell Lymphoma. The main purpose of using Epcoritamab is to help the immune system target and destroy cancer cells. It works by binding to specific proteins on the surface of cancer cells and immune cells, helping the immune system recognize and attack the cancer. Epcoritamab is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Relapsed/Refractory Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that affects B cells, which are a type of white blood cell. It occurs when the disease returns after treatment (relapsed) or does not respond to initial therapy (refractory). The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. As it progresses, it can cause symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease is characterized by the rapid growth of large B cells, which can form tumors in various parts of the body. Over time, it can lead to complications due to the impaired function of the immune system.