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Study of Acalabrutinib with R-CHOP for Patients with Untreated Mantle Cell Lymphoma in Spain

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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 (MCL), which is a rare form of non-Hodgkin's lymphoma. The study will evaluate a treatment that combines a medication called with a standard chemotherapy regimen known as . Acalabrutinib, also known by its code name , is a type of drug that targets specific proteins in cancer cells to help stop their growth. R-CHOP is a combination of drugs commonly used to treat lymphoma, including rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.

The purpose of this study is to assess how well the combination of acalabrutinib and R-CHOP works in treating patients who have not received any previous treatment for their MCL. Participants in the study will take acalabrutinib in the form of film-coated tablets, along with the R-CHOP regimen. The study will monitor the response to the treatment over a period of time to see how effective it is in managing the disease.

Throughout the study, participants will be closely observed to track their response to the treatment and any side effects they may experience. The study aims to provide valuable information on the effectiveness of this treatment combination for individuals with previously untreated mantle cell lymphoma. The trial is expected to continue until the end of 2028, with recruitment starting in mid-2025.

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 provide signed and dated informed consent. This confirms your understanding of the study's purpose and any potential risks involved.

    You must be able to swallow tablets without difficulty and agree to participate in all required evaluations and procedures.

  2. Step 2

    Treatment initiation

    The treatment involves taking acalabrutinib in combination with the R-CHOP standard of care. Acalabrutinib is administered as Calquence 100 mg film-coated tablets taken orally.

    The R-CHOP regimen includes a combination of drugs: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. The specific dosages and schedule will be provided by your healthcare team.

  3. Step 3

    Treatment duration

    The duration of the treatment will be determined by your healthcare provider based on your response to the medication and any side effects experienced.

    Regular assessments will be conducted to monitor your progress and adjust the treatment plan as necessary.

  4. Step 4

    Follow-up and monitoring

    Throughout the study, you will undergo regular follow-up visits to assess your health and the effectiveness of the treatment.

    These visits may include physical examinations, blood tests, and imaging studies to evaluate your response to the treatment.

  5. Step 5

    End of treatment

    At the end of the treatment period, a final assessment will be conducted to determine the overall response to the therapy.

    You will receive guidance on any further steps or additional treatments that may be necessary based on the study's findings.

Who can join the trial?

11 criteria

  • Adults aged 18 years or older, both men and women, can participate.
  • Participants must be willing and able to take part in all required evaluations and procedures, including swallowing tablets without difficulty.
  • Participants must understand the purpose and risks of the study and provide signed and dated informed consent, allowing the use of their health information.
  • Participants must be unsuitable for autologous stem cell transplantation (a procedure where a person's own stem cells are used to replace damaged or diseased bone marrow).
  • Women of childbearing potential who are sexually active must use highly effective contraception during the study and for a specified time after the last dose of certain medications.
  • Men must use barrier contraception, like condoms, during the study and for a specified time after the last dose of certain medications. Men wishing to father children in the future should consider freezing sperm before starting the study.
  • Participants must have a confirmed diagnosis of mantle cell lymphoma (MCL) with specific genetic markers.
  • Participants must need treatment for MCL and have not received any prior systemic anticancer therapies.
  • Participants must have measurable signs of the disease, such as enlarged lymph nodes, spleen, or other lymphoid tissues, visible on imaging tests.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, which means they are capable of self-care and are up and about more than 50% of waking hours.
  • Men must agree not to donate sperm during the study and for a specified time after the last dose of certain medications.

Who cannot join the trial?

10 criteria

  • Patients who have received any previous treatment for mantle cell lymphoma (MCL) cannot participate. This means if you have already been treated for this specific type of cancer, you are not eligible.
  • Patients with other active cancers, meaning if you currently have another type of cancer that is being treated or needs treatment, you cannot join the study.
  • Patients with serious heart problems, such as heart failure or recent heart attacks, are not eligible. Heart failure is when the heart doesn't pump blood as well as it should.
  • Patients with uncontrolled high blood pressure, which means your blood pressure is not being managed well with medication or lifestyle changes, cannot participate.
  • Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are excluded. This means if you have an infection that needs medication to treat, you cannot join.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients with known allergies to the study drugs or their ingredients are not eligible. If you have had allergic reactions to similar medications, you cannot join the study.
  • Patients with a history of certain blood disorders, which affect how your blood cells work, are excluded.
  • Patients who have had a major surgery within the last 4 weeks are not eligible. Major surgery is a significant operation that requires a longer recovery time.
  • Patients with a history of drug or alcohol abuse within the last 6 months cannot participate. This means if you have had problems with drugs or alcohol recently, you are not eligible.
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Investigated drugs

  • Acalabrutinib

    is a medication used in this study to help treat mantle cell lymphoma, a type of cancer that affects the lymph nodes. It works by blocking a specific protein in the body that helps cancer cells grow. By stopping this protein, acalabrutinib can help slow down or stop the growth of cancer cells.

  • R-CHOP

    is a combination of several medications that are commonly used together to treat certain types of cancer, including mantle cell lymphoma. Each letter in R-CHOP stands for a different medication that works in a unique way to attack cancer cells. This combination is considered a standard treatment and is used to help reduce the number of cancer cells in the body and improve symptoms.

What is already known about the treatment

Acalabrutinib – Acalabrutinib is taken orally and is currently being studied in combination with the R-CHOP standard of care for treating mantle cell lymphoma (MCL), a type of blood cancer. It is in the clinical trial phase, specifically a phase II study, to evaluate its effectiveness in patients who have not been treated for MCL before. The medication works by blocking a specific protein in the body that helps cancer cells grow, which may slow down or stop the progression of the disease. Acalabrutinib is classified as a Bruton’s tyrosine kinase (BTK) inhibitor, a type of targeted cancer therapy.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a kind 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 and gastrointestinal tract. As it advances, it can affect the body's ability to fight infections. The progression of Mantle Cell Lymphoma can vary, with some cases growing slowly while others may progress more rapidly. It is characterized by the overproduction of abnormal B-cells, which can crowd out healthy cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521152-34-00Protocol codeD8220L00087Estimated enrolment55 patientsSponsorAstrazeneca Farmaceutica Spain S.A.

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