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Study on Lenalidomide, Tafasitamab, and Rituximab for Treating Diffuse Large B-Cell Lymphoma in Patients Aged 80 and Older

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 the effectiveness of a combination of medications for treating Diffuse Large B-Cell Lymphoma, a type of cancer that affects the lymphatic system. The treatment being tested includes a combination of three medications: Lenalidomide, Tafasitamab, and Rituximab. Lenalidomide is taken orally in the form of capsules, Tafasitamab is administered through an intravenous infusion, and Rituximab is given as a solution for injection or infusion.

The purpose of the study is to evaluate how well this combination of medications works in patients who are 80 years old or older. Participants will receive these treatments over a series of cycles, with the goal of assessing the overall response rate, which measures how the cancer responds to the treatment. The study will also monitor the safety of the medications and their impact on the quality of life of the participants.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of using this combination of medications for treating elderly patients with Diffuse 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.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an Informed Consent Form. This form confirms that you understand the study and agree to participate.

    You will undergo initial assessments to ensure you meet the study's eligibility criteria, such as having a confirmed diagnosis of Diffuse Large B-Cell Lymphoma and being 80 years or older.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications: rituximab, tafasitamab, and lenalidomide. These medications are used to treat your condition.

    Rituximab is administered as a solution for infusion, which means it is given through a vein. Tafasitamab is also given as an infusion. Lenalidomide is taken orally in the form of capsules.

  3. Step 3

    Treatment cycles

    The treatment is organized into cycles. Each cycle lasts for a specific period, during which you will receive the medications at scheduled intervals.

    The study aims to evaluate the effectiveness of the treatment after three cycles or if the treatment is permanently discontinued earlier.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular medical assessments and imaging tests like PET-CT scans.

    These assessments help determine how well the treatment is working and ensure your safety during the study.

  5. Step 5

    End of participation

    Your participation in the study will conclude after the specified treatment cycles or if you choose to withdraw from the study.

    At the end of your participation, final assessments will be conducted to evaluate your overall response to the treatment.

Who can join the trial?

11 criteria

  • Patient must understand and voluntarily sign an Informed Consent Form before any study-specific assessments or procedures are conducted.
  • Patients should be able to receive the R-miniCHOP regimen, which means having a left ventricular ejection fraction greater than 50% and being in good general condition according to the investigator's judgment.
  • Patients should be able to receive adequate prevention or treatment for thromboembolic events (blood clots), using aspirin or low molecular weight heparin.
  • Patient must have a histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) according to the WHO classification 2017, including all clinical subtypes.
  • Patient must have Positron-Emission Tomography (PET)-positive disease, which means the disease is detectable using a PET scan.
  • Patient must have previously untreated high-grade B-cell lymphoma.
  • Patient must be aged 80 years or older at the time of signing the informed consent form.
  • Patient must be at Ann Arbor stage I, II, III, or IV, which refers to the extent of the lymphoma in the body.
  • Patient must have an ECOG performance status of 2 or less, which measures the patient's level of functioning.
  • Patient must have a minimum life expectancy of 3 months.
  • Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 4 months following study drug discontinuation, even if they have undergone a successful vasectomy.

Who cannot join the trial?

3 criteria

  • Patients who do not have Diffuse Large B-Cell Lymphoma cannot participate.
  • Patients who are not in the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by stopping the growth of cancer cells and reducing the blood supply to tumors. In this trial, it is used to treat a type of cancer called Diffuse Large B-Cell Lymphoma in elderly patients.

  • Tafasitamab

    is an antibody that targets a specific protein on the surface of cancer cells. By attaching to this protein, it helps the immune system recognize and destroy the cancer cells. This medication is used in combination with others to improve the treatment of Diffuse Large B-Cell Lymphoma.

  • Rituximab

    is a medication that also targets cancer cells by attaching to a specific protein on their surface. It helps the immune system to find and eliminate these cells. In this trial, rituximab is used alongside other medications to enhance the treatment's effectiveness for patients with Diffuse Large B-Cell Lymphoma.

What is already known about the treatment

  • Lenalidomide

    Lenalidomide is administered orally in the form of capsules. It is currently being studied in combination with other medications for its effectiveness in treating Diffuse Large B-Cell Lymphoma, particularly in elderly patients. The main therapeutic indication for lenalidomide in this trial is to help improve the response rate in patients with this type of lymphoma. At the molecular level, lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory drug.

  • Tafasitamab

    Tafasitamab is administered intravenously, meaning it is given directly into a vein. It is an anti-CD19 antibody currently being evaluated for its effectiveness in combination with other drugs for treating Diffuse Large B-Cell Lymphoma in older patients. The main therapeutic indication is to enhance the overall response rate in these patients. Tafasitamab works by targeting and binding to the CD19 protein on the surface of B-cells, leading to the destruction of these cancerous cells. It is classified as a monoclonal antibody.

  • Rituximab

    Rituximab is also administered intravenously and is being studied in combination with other medications for its role in treating Diffuse Large B-Cell Lymphoma in elderly patients. The main therapeutic indication is to improve the treatment response in these patients. Rituximab works by targeting the CD20 protein on the surface of B-cells, which helps the immune system destroy these cancerous cells. It is classified as a monoclonal antibody.

Investigated diseases

Diffuse Large B-Cell Lymphoma – Diffuse Large B-Cell Lymphoma is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with a painless swelling in the neck, armpit, or groin due to enlarged lymph nodes. As it progresses, it can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 4 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-507286-25-00Protocol codeVERLENEstimated enrolment45 patientsSponsorLysarc

sourced from the EU Clinical Trials Register and site verification

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