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Study on Brentuximab Vedotin, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

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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 or refractory diffuse large B-cell lymphoma (DLBCL). This condition occurs when the cancer returns or does not respond to treatment. The study is testing a combination of medications to see how well they work together. The medications being studied are Brentuximab Vedotin, Lenalidomide, and Rituximab. Brentuximab Vedotin is a medication that targets cancer cells, Lenalidomide is an immunomodulatory drug that helps the immune system fight cancer, and Rituximab is a monoclonal antibody that targets specific proteins on cancer cells.

The purpose of the study is to evaluate how these medications work together in treating patients with DLBCL. Participants in the study will receive either the combination of Brentuximab Vedotin, Lenalidomide, and Rituximab or a combination that includes a placebo instead of Brentuximab Vedotin. A placebo is a substance with no active medication. The study will compare the effects of these treatments over a period of time to see which is more effective in preventing the cancer from getting worse.

Throughout the study, participants will receive the medications through subcutaneous injections, which means the medication is given under the skin, and oral capsules, which are taken by mouth. The study will monitor the participants' health and the progression of their cancer to gather information on the effectiveness and safety of the treatment combinations. The goal is to find out if the combination of these medications can help improve the outcomes for patients with relapsed or refractory DLBCL.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    A series of tests and evaluations are performed to ensure the patient meets the study criteria, such as age, health condition, and previous treatments.

  2. Step 2

    Treatment assignment

    Patients are randomly assigned to one of two treatment groups. One group receives a combination of brentuximab vedotin, lenalidomide, and rituximab, while the other group receives a placebo instead of brentuximab vedotin.

    The assignment is double-blind, meaning neither the patient nor the study team knows which group the patient is in.

  3. Step 3

    Treatment administration

    Brentuximab vedotin is administered via subcutaneous injection. The dosage and frequency are determined by the study protocol.

    Lenalidomide is taken orally in the form of 5 mg hard capsules. The dosage and frequency are specified in the study protocol.

    Rituximab is also administered via subcutaneous injection, with dosage and frequency outlined in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment and to identify any side effects. This includes physical exams, blood tests, and imaging studies.

    Follow-up visits are scheduled according to the study timeline to ensure ongoing evaluation of the patient's health and treatment efficacy.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date or until the patient completes the prescribed course of treatment.

    Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

16 criteria

  • Patients must have **relapsed or refractory diffuse large B-cell lymphoma (DLBCL)**, which means the cancer has returned or not responded to treatment.
  • Patients must be 18 years or older.
  • Patients must have had at least two previous treatments for their disease.
  • Patients must not be eligible for **HSCT** (a type of stem cell transplant) or **CAR-T therapy** (a type of cell therapy) due to medical reasons or other issues like financial or geographic barriers.
  • Patients must have a **tumor tissue sample** sent to a lab to check for a protein called **CD30**.
  • Patients must have a performance status score of 0 to 2, which measures their ability to perform daily activities.
  • Patients must have a type of disease that can be seen on a **PET scan** and measured on a **CT scan**.
  • Patients must have certain **blood test results** within specific ranges, such as:
    • **Neutrophil count** (a type of white blood cell) of at least 1000/μL.
    • **Platelet count** of at least 50,000/μL.
    • **Hemoglobin** level of at least 8.0 g/dL.
    • **Bilirubin** level within normal limits, unless they have certain conditions.
    • **Kidney function** with an estimated filtration rate of at least 45 mL/min.
    • **Liver enzymes** (ALT and AST) within certain limits.
    • Patients who can have children must agree to use birth control and not donate sperm or eggs during the study and for 12 months after the last dose of the study drug.
    • Patients who are **HIV positive** must meet specific health criteria, such as having a certain level of **CD4+ T-cells** and being on stable HIV treatment.
    • Patients must provide written consent to participate in the study.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides relapsed or refractory diffuse large B-cell lymphoma (DLBCL) cannot participate. This means if you have a different kind of cancer, you are not eligible.
  • Patients who have not experienced a return of their lymphoma after treatment or whose lymphoma has not stopped responding to treatment are excluded. In simple terms, if your lymphoma is not coming back or is still responding to treatment, you cannot join.
  • Patients who are not within the specified age range for the study cannot participate. This means if you are too young or too old according to the study's age limits, you are not eligible.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate are excluded. This means if you have health issues that make it risky or difficult to be part of the study, you cannot join.
  • Patients who are pregnant or breastfeeding are not allowed to participate. This means if you are expecting a baby or nursing, you cannot be part of the study.
  • Patients who have participated in another clinical trial recently may be excluded. This means if you have been part of another study not long ago, you might not be eligible.
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Investigated drugs

  • Brentuximab Vedotin

    is a medication used in this trial to treat patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL). It works by targeting and destroying cancer cells, helping to slow down or stop the growth of the tumor.

  • Lenalidomide

    is another medication used in the trial. It helps the immune system fight cancer by affecting the way the immune cells work. It can also stop cancer cells from growing and spreading.

  • Rituximab

    is a medication that targets specific proteins on the surface of cancer cells. It helps the immune system to identify and destroy these cancer cells, which can help in treating DLBCL.

What is already known about the treatment

  • Brentuximab Vedotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is an antibody-drug conjugate that targets CD30-positive cells, delivering a cytotoxic agent directly to cancer cells, which helps to stop their growth and spread. Brentuximab Vedotin is classified as an antineoplastic agent and is being evaluated for its ability to improve progression-free survival in patients with this type of lymphoma.

  • Lenalidomide

    Taken orally, Lenalidomide is part of ongoing research for its role in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It works by modulating the immune system and inhibiting the growth of cancer cells, which can help in controlling the disease. Lenalidomide is classified as an immunomodulatory agent and is being assessed for its potential to enhance progression-free survival in affected patients.

  • Rituximab

    Administered through intravenous infusion, Rituximab is being investigated in clinical trials for its use in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is a monoclonal antibody that targets the CD20 protein on the surface of B-cells, leading to their destruction. Rituximab is classified as a biologic antineoplastic agent and is being studied for its effectiveness in improving progression-free survival in this patient population.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This 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, or other organs. The disease can occur at any age but is more common in older adults. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can be classified as relapsed or refractory when it does not respond to initial treatment or returns after treatment. The progression of the disease can vary, with some cases advancing quickly while others may progress more slowly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503384-41-00Protocol codeSGN35-031Estimated enrolment218 patientsSponsorSeagen Inc.

sourced from the EU Clinical Trials Register and site verification

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