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Study on the Effects of Acalabrutinib in Patients with Relapsed or Refractory Mantle Cell Lymphoma

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 effects of a medication called acalabrutinib in patients with a type of cancer known as Mantle Cell Lymphoma. Mantle Cell Lymphoma is a rare form of non-Hodgkin's lymphoma, which is a cancer that affects the lymphatic system, a part of the immune system. The medication being tested, acalabrutinib, is available in two forms: film-coated tablets and hard capsules, both containing 100 mg of the active substance.

The purpose of the study is to evaluate how well acalabrutinib works in patients whose Mantle Cell Lymphoma has returned or has not responded to previous treatments. The study will look at how many patients experience a reduction in their cancer, how long these responses last, and how long patients live without the disease getting worse. The study will also monitor the overall survival of the participants. Participants will take the medication orally, meaning they will swallow the tablets or capsules.

Throughout the study, researchers will also assess the safety of acalabrutinib by recording any side effects experienced by the participants. Additionally, the study will examine how the medication affects certain blood cells and proteins in the body. The trial is designed to gather important information about the effectiveness and safety of acalabrutinib for treating Mantle Cell Lymphoma, with the goal of improving treatment options for patients with this condition.

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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments for mantle cell lymphoma.

    Consent is required to participate, which involves understanding the study's purpose and potential risks.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and confirm the presence of mantle cell lymphoma.

    This includes imaging tests to measure lymphadenopathy or extranodal lymphoid malignancy.

  3. Step 3

    Medication administration

    The medication acalabrutinib is administered orally in the form of either 100 mg film-coated tablets or hard capsules.

    The dosage and frequency are determined by the study protocol, and the medication is taken as directed for the duration of the study.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the response to the medication, including the overall response rate, duration of response, and progression-free survival.

    Safety assessments are performed to monitor any adverse effects and adjust the treatment if necessary.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to determine the overall effectiveness of the treatment.

    This includes a comprehensive review of the patient's response to the medication and any changes in health status.

Who can join the trial?

10 criteria

  • Men and women who are **18 years or older**.
  • Willing and able to take part in all necessary evaluations and procedures, including swallowing capsules or tablets without any trouble.
  • Must understand the purpose and risks of the study and provide signed and dated consent to use their health information.
  • Must have a confirmed diagnosis of **Mantle Cell Lymphoma (MCL)**, with specific cell characteristics involving a chromosome change or overexpression of a protein called cyclin D1.
  • The disease must have returned or not responded to at least one previous treatment for MCL and now needs further treatment.
  • Must have documented failure to achieve at least a **Partial Response (PR)** or documented disease progression after the most recent treatment.
  • Must have measurable disease, meaning there is a lymph node or other lymph-related tumor that can be measured by a **CT scan** and is of a certain size.
  • Must have had at least one, but no more than five, previous treatment regimens for MCL. If they have had at least two cycles of treatment with a drug like bortezomib, they are considered to have been exposed to a **proteasome inhibitor**.
  • Must have an **ECOG performance status** of 2 or less, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Women who are sexually active and can have children must agree to use highly effective birth control during the study and for two days after the last dose of the study drug.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of blood cancer.
  • Patients who have not experienced a return or worsening of their Mantle Cell Lymphoma after treatment are not eligible. This means the cancer must have come back or not responded to previous treatments.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults, but specific age limits may apply.
  • Patients who are not able to provide informed consent, which means they cannot understand and agree to the study procedures, are excluded.
  • Patients who are pregnant or breastfeeding are not eligible to participate in the study.
  • Patients who have certain other medical conditions that might interfere with the study or make participation unsafe are excluded. These conditions will be assessed by the study doctors.
  • Patients who are currently participating in another clinical trial or have recently participated in one may not be eligible.
  • Patients who have had a recent major surgery or have not fully recovered from a previous surgery may be excluded.
  • Patients who have an active infection or other serious illness that could affect their participation in the study are not eligible.
  • Patients who have a history of certain heart problems or other significant health issues may be excluded from the study.
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Investigated drugs

Acalabrutinib is a medication being studied for its effectiveness in treating patients with mantle cell lymphoma, a type of cancer that affects the lymph nodes. The main goal of the trial is to see how well acalabrutinib works in patients whose cancer has returned or has not responded to previous treatments. Researchers are looking at how many patients respond to the treatment, how long the response lasts, and how long patients live without the cancer getting worse.

What is already known about the treatment

Acalabrutinib – Acalabrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, particularly in patients who have relapsed or have not responded to previous treatments. The medication works by inhibiting a specific enzyme called Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells. Acalabrutinib is classified as a targeted therapy, specifically a BTK inhibitor, and is being evaluated for its ability to improve response rates and survival outcomes in affected individuals.

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, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing more rapidly than others. It is considered a rare form of lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509352-34-00Protocol codeACE-LY-004Estimated enrolment10 patientsSponsorAcerta Pharma B.V.

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