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Study on Bendamustine, Rituximab, and Acalabrutinib for Patients with Untreated Mantle 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 Mantle Cell Lymphoma, which is a rare form of non-Hodgkin's lymphoma. The study is investigating the effectiveness of a treatment combination that includes the drugs Bendamustine, Rituximab, and Acalabrutinib (also known by its code name ACP-196). The purpose of the study is to evaluate how well this combination works compared to Bendamustine and Rituximab alone, with or without a placebo.

Participants in the study will receive treatment over a period of time, during which they will be given the medications either through an intravenous method, which means the drugs are delivered directly into a vein, or orally, which means they are taken by mouth in the form of capsules. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

The trial aims to assess the progression-free survival of patients, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. This assessment will be done according to specific guidelines for non-Hodgkin's lymphoma. The study will help determine if adding Acalabrutinib to the treatment regimen provides any additional benefit to patients with previously untreated Mantle Cell Lymphoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment involves the use of bendamustine and rituximab, administered through intravenous use. This phase is designed to target mantle cell lymphoma, a type of cancer affecting the lymph nodes.

    During this phase, bendamustine is given on days 1 and 2 of each 28-day cycle. The dosage and specific administration details will be provided by the healthcare team.

    Rituximab is administered on day 1 of each cycle. The healthcare team will monitor the response to treatment and adjust as necessary.

  2. Step 2

    Combination treatment phase

    In addition to bendamustine and rituximab, some patients will receive acalabrutinib in the form of oral capsules. This medication is taken twice daily.

    The purpose of adding acalabrutinib is to evaluate its effectiveness in combination with the other medications. The healthcare team will provide guidance on how to take the capsules.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular assessments will be conducted to monitor the progression of the lymphoma and the effectiveness of the treatment.

    These assessments may include imaging tests and blood tests to evaluate the response to the medications.

  4. Step 4

    Follow-up phase

    After completing the treatment cycles, follow-up visits will be scheduled to continue monitoring the patient's health and any long-term effects of the treatment.

    The duration and frequency of follow-up visits will be determined by the healthcare team based on individual patient needs.

Who can join the trial?

9 criteria

  • Men and women who are **65 years of age or older**.
  • Must have a confirmed diagnosis of **Mantle Cell Lymphoma (MCL)**, which is a type of cancer, with specific genetic markers or proteins present.
  • The MCL must need treatment, and the patient should not have received any previous cancer treatments for it.
  • There must be **measurable signs of the disease** in the body, such as enlarged lymph nodes or other affected areas.
  • Have an **ECOG performance status** of 2 or less, which means the patient should be able to carry out all self-care but unable to carry out any work activities. They should be up and about more than 50% of waking hours.
  • Men who are sexually active and can father children must agree to use **highly effective birth control** during the study and for a certain period after the last dose of the study drugs.
  • Men must also agree not to **donate sperm** during the study and for a certain period after the last dose of the study drugs.
  • Must be willing and able to participate in all required evaluations and procedures, including being able to **swallow capsules** without difficulty.
  • Must be able to understand the purpose and risks of the study and provide **signed consent** to participate and allow the use of their health information.

Who cannot join the trial?

5 criteria

  • Patients who have received previous treatment for Mantle Cell Lymphoma. This means if you have already been treated for this type of cancer, you cannot participate.
  • Patients with other serious health conditions that might interfere with the study. This includes any illness that could make it unsafe for you to participate.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures. This means if you cannot attend appointments or follow instructions, you may not be eligible.
  • Patients with a history of allergic reactions to the study medications. If you have had severe allergies to similar drugs, you cannot join the study.
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Investigated drugs

  • Bendamustine

    is a medication used in the treatment of certain types of cancer, including mantle cell lymphoma. It works by interfering with the growth of cancer cells, which are eventually destroyed. In this trial, it is used as part of a combination therapy to evaluate its effectiveness in treating mantle cell lymphoma.

  • Rituximab

    is a medication that targets specific proteins on the surface of cancer cells. It is used to treat various types of lymphoma, including mantle cell lymphoma. Rituximab helps the immune system to identify and destroy cancer cells. In this study, it is combined with other medications to assess its role in improving treatment outcomes.

  • Acalabrutinib (ACP-196)

    is a newer medication being studied for its potential to treat mantle cell lymphoma. It works by blocking certain enzymes that help cancer cells grow and survive. The trial aims to determine if adding acalabrutinib to the standard treatment of bendamustine and rituximab can improve the effectiveness of the therapy.

What is already known about the treatment

  • Acalabrutinib

    Acalabrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, a type of non-Hodgkin lymphoma. It is a targeted therapy that works by inhibiting Bruton's tyrosine kinase (BTK), a protein involved in the growth and survival of cancer cells. Acalabrutinib is classified as a BTK inhibitor and is being evaluated for its ability to improve progression-free survival in patients with this condition.

  • Bendamustine

    Bendamustine is given intravenously and is an established treatment for mantle cell lymphoma. It is a chemotherapy drug that works by damaging the DNA of cancer cells, preventing them from dividing and growing. Bendamustine is classified as an alkylating agent and is used in combination with other medications to enhance its therapeutic effects.

  • Rituximab

    Rituximab is administered via intravenous infusion and is widely used in the treatment of mantle cell lymphoma. 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 therapy and is often used in combination with chemotherapy to improve treatment outcomes.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fatigue, and weight loss. As the disease advances, it can affect the body's ability to fight infections. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-509354-58-00Protocol codeACE-LY-308Estimated enrolment636 patientsSponsorAcerta Pharma B.V.

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