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Study on the Effects and Safety of Daratumumab, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Plasmablastic 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 Plasmablastic Lymphoma, which can be challenging to treat, especially when it returns or does not respond to initial treatments. The study is testing a combination of three medications: Daratumumab, Bortezomib, and Dexamethasone. Daratumumab is a type of protein that targets specific cells in the body, Bortezomib is a medication that helps stop the growth of cancer cells, and Dexamethasone is a steroid that can reduce inflammation and help with the effectiveness of cancer treatments.

The purpose of this study is to evaluate how well these medications work together in patients with Plasmablastic Lymphoma that has either returned after treatment or has not responded to previous treatments. The study will observe the effects of these medications over a period of time to see if they can help control the disease. Participants will receive these medications in a specific order and combination, and their health will be monitored regularly to assess the treatment's impact.

Throughout the study, researchers will look at how the cancer responds to the treatment, how long patients remain free from disease progression, and overall survival rates. The study will also explore how the treatment affects the body's immune system and other biological factors. This research aims to provide more information on the potential benefits of using Daratumumab, Bortezomib, and Dexamethasone together for treating Plasmablastic 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.

  1. Step 1

    Induction phase

    The induction phase begins with the administration of daratumumab alone. This medication is given through a subcutaneous injection. The purpose of this phase is to evaluate the initial response to the treatment.

    Following the initial administration, the treatment continues with a combination of daratumumab, bortezomib, and dexamethasone. Bortezomib is also administered subcutaneously, while dexamethasone is taken orally. This combination is repeated in cycles, with evaluations after cycles 3, 6, and 9 to assess the response to the treatment.

  2. Step 2

    Maintenance phase

    After completing the induction phase, the maintenance phase begins. This phase involves continued administration of daratumumab to maintain the response achieved during the induction phase.

    Evaluations are conducted after cycles 12 and 15 to determine the effectiveness of the maintenance treatment and to monitor any changes in the condition.

  3. Step 3

    End of treatment

    The end of treatment is reached after the completion of the maintenance phase. The overall response to the treatment is assessed, including any changes in the condition and the duration of the response.

    The study aims to understand the impact of the treatment on survival rates and the progression of the condition.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of **plasmablastic lymphoma**, which is a type of cancer, and the cancer cells must show a certain marker called **CD38**.
  • The patient should be able to attend all study visits and follow the study rules.
  • The patient must have **plasmablastic lymphoma** that has come back or not responded to treatment after at least one round of standard chemotherapy, with or without a previous stem cell transplant.
  • The patient must have a performance status of **3 or less** on the **ECOG scale**, which measures how well a patient can perform daily activities.
  • The patient must be **18 years or older**.
  • Both **HIV-negative** and **HIV-positive** patients can participate, as long as the HIV infection is controlled with ongoing treatment.
  • The patient must have at least one measurable area of disease that can be seen on imaging tests. This means a tumor in a lymph node must be a certain size, or a tumor outside of lymph nodes must be a certain size.
  • Women who can have children and men must agree to use effective birth control if they are sexually active, from the time they sign the consent form until several months after the last dose of study medication. Women must have two negative pregnancy tests before starting the study and agree to monthly pregnancy tests during the study.
  • The patient must understand and willingly sign a consent form approved by the National Ethics Committee before any study procedures begin.

Who cannot join the trial?

2 criteria

  • Patients who are eligible for **autologous** or **allogeneic transplantation** cannot participate. This means if you can receive a transplant using your own cells or cells from a donor, you are not eligible.
  • Patients who have not experienced a **relapse** after a prior **autologous stem cell transplantation** are excluded. A relapse means the return of the disease after treatment.
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Investigated drugs

  • Daratumumab

    is a medication used in this trial to treat patients with relapsed or refractory Plasmablastic lymphoma. It is a type of therapy that targets specific proteins on the surface of cancer cells, helping the immune system to identify and destroy these cells.

  • Bortezomib

    is another medication involved in the trial. It works by interfering with the growth of cancer cells, ultimately leading to their death. This medication is often used in combination with other drugs to enhance its effectiveness against cancer.

  • Dexamethasone

    is a steroid medication used in the trial to help reduce inflammation and suppress the immune system. It is often used alongside other cancer treatments to help manage side effects and improve the overall effectiveness of the therapy.

What is already known about the treatment

  • Daratumumab

    This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory plasmablastic lymphoma, a type of cancer. Daratumumab works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

  • Bortezomib

    This medication is typically administered as an injection under the skin or into a vein. It is being evaluated in combination with other drugs for treating relapsed or refractory plasmablastic lymphoma. Bortezomib works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor, used in cancer treatment.

  • Dexamethasone

    This medication is usually taken orally in the form of a tablet. It is part of a combination therapy being studied for relapsed or refractory plasmablastic lymphoma. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune response, which can help in managing cancer symptoms and enhancing the effects of other cancer treatments. It is classified as a glucocorticoid.

Investigated diseases

Plasmablastic Lymphoma – Plasmablastic lymphoma is a rare and aggressive type of non-Hodgkin lymphoma that primarily affects the immune system. It is characterized by the rapid growth of abnormal B-cells, which are a type of white blood cell. These cells often form tumors in the lymph nodes, but they can also appear in other parts of the body, such as the bone marrow, skin, or oral cavity. The disease is more commonly seen in individuals with weakened immune systems, such as those with HIV/AIDS. As the disease progresses, it can lead to symptoms like swollen lymph nodes, fever, night sweats, and weight loss. The progression of plasmablastic lymphoma can be rapid, requiring prompt medical attention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511635-94-00Estimated enrolment28 patientsSponsorFondazione Italiana Linfomi Ets

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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