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Study on Ibrutinib and Drug Combination for Patients with Generalized 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 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 that includes a combination of medications: Rituximab, Ibrutinib, and Ara-C (cytarabine). Ibrutinib is a medication that works by blocking certain proteins that help cancer cells grow. The purpose of the study is to determine the best treatment approach for patients with generalized mantle cell lymphoma.

Participants in the study will be randomly assigned to one of three groups. The first group will receive a standard treatment known as R-CHOP followed by R-DHAP and an autologous stem cell transplant (ASCT). The second group will receive R-CHOP with Ibrutinib, followed by R-DHAP, ASCT, and maintenance therapy with Ibrutinib. The third group will receive R-CHOP with Ibrutinib, followed by R-DHAP and maintenance therapy with Ibrutinib, but without the stem cell transplant. The study aims to compare the outcomes of these different treatment strategies.

The trial will monitor participants over a period to assess their response to the treatment, focusing on how long they remain free from disease progression or any other complications. The study will also look at overall survival rates and the occurrence of any side effects. This research is part of a larger effort to improve treatment options for patients with mantle cell lymphoma.

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, a physical examination, and laboratory tests to ensure all criteria are met.

    Eligibility criteria include a confirmed diagnosis of mantle cell lymphoma, age between 18 and 65 years, and specific laboratory values. A written informed consent form must be signed.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three study groups. This process is called randomization and ensures that each participant has an equal chance of being placed in any group.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving specific medications based on the assigned group. The groups are as follows:

    Control Arm A: Receives R-CHOP/R-DHAP followed by autologous stem cell transplantation (ASCT).

    Experimental Arm A+I: Receives R-CHOP with ibrutinib/R-DHAP followed by ASCT and ibrutinib maintenance.

    Experimental Arm I: Receives R-CHOP with ibrutinib/R-DHAP followed by ibrutinib maintenance.

    The medication ibrutinib is taken orally. The dosage and frequency are determined by the study protocol and the healthcare team.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor health status and response to treatment. These assessments include physical exams, laboratory tests, and imaging studies.

    The primary goal is to evaluate failure-free survival, which measures the time until disease progression or any cause of death.

  5. Step 5

    End of study

    The study concludes with a final assessment to determine the overall response to treatment. This includes evaluating overall survival and progression-free survival.

    Participants may continue to be monitored for long-term outcomes and any potential side effects.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of MCL (Mantle Cell Lymphoma) according to the WHO classification.
  • Men and women who can have children must agree to use highly effective birth control methods, such as combined oral contraceptives, implants, injectables, intrauterine devices, or a sterilized partner, along with barrier methods like latex condoms or diaphragms, while participating in the study. This should continue for 90 days after the last dose of the study drug and 12 months after the last dose of rituximab.
  • Must be suitable for high-dose treatment, including high-dose Ara-C (a type of chemotherapy).
  • Must have cancer at Stage II-IV according to the Ann Arbor staging system.
  • Must be between 18 and 65 years old.
  • Must not have received any previous treatment for MCL.
  • Must have at least one measurable tumor. If the cancer is only in the bone marrow, a bone marrow aspiration and biopsy are required for all evaluations.
  • Must have an ECOG/WHO performance status of 2 or less, which means the patient is able to carry out all self-care but unable to carry out any work activities.
  • Must have certain laboratory test results at screening, unless related to MCL:
    • Absolute neutrophil count (ANC) of at least 1000 cells.
    • Platelet count of at least 100,000 cells.
    • Transaminases (AST and ALT) levels no more than 3 times the upper limit of normal.
    • Total bilirubin no more than 2 times the upper limit of normal, unless due to known Morbus Meulengracht (Gilbert-Meulengracht Syndrome).
    • Creatinine level no more than 2 mg/dL or calculated creatinine clearance of at least 50 mL/min.
    • Must provide a written informed consent form according to international and national regulations.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not Generalized mantle cell Lymphoma.
  • Patients who have had a different cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients with serious heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients with known allergies to the study drugs.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

  • Rituximab

    is a medication used in this trial to help treat mantle cell lymphoma, a type of cancer. It works by targeting specific cells in the immune system that are involved in the growth of cancer. By doing this, it helps to slow down or stop the progression of the disease.

  • Ibrutinib

    is another medication used in the trial. It is designed to interfere with the signals that cancer cells need to grow and divide. By blocking these signals, ibrutinib can help to reduce the number of cancer cells and slow the progression of the disease.

  • Ara-C

    , also known as cytarabine, is a chemotherapy drug used in the trial. It works by interfering with the DNA of cancer cells, which prevents them from growing and multiplying. This helps to reduce the number of cancer cells in the body.

  • R-CHOP

    is a combination of several chemotherapy drugs used together to treat cancer. Each drug in this combination works in a different way to attack cancer cells, making it a powerful treatment option for mantle cell lymphoma.

  • R-DHAP

    is another combination of chemotherapy drugs used in the trial. Like R-CHOP, it combines different medications to target cancer cells in multiple ways, helping to improve the effectiveness of the treatment.

  • ASCT

    , or autologous stem cell transplantation, is a procedure used in the trial. It involves collecting healthy stem cells from the patient's own body, which are then used to replace damaged or destroyed bone marrow after intensive chemotherapy. This helps the body to recover and produce healthy blood cells.

What is already known about the treatment

  • Rituximab

    Rituximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently well-established in medical practice and literature, particularly for treating certain types of blood cancers and autoimmune diseases. The main therapeutic indication for Rituximab in this trial is generalized mantle cell lymphoma. At the molecular level, Rituximab works by targeting a specific protein called CD20 found on the surface of certain white blood cells, leading to their destruction. It is classified as a monoclonal antibody in pharmacology.

  • Ibrutinib

    Ibrutinib is taken orally in the form of a capsule. It is widely recognized in the medical field for its role in treating various blood cancers, including mantle cell lymphoma. The primary therapeutic use of Ibrutinib in this trial is for generalized mantle cell lymphoma. On a molecular level, Ibrutinib blocks a protein called Bruton's tyrosine kinase (BTK), which is important for the survival and growth of cancer cells. It is classified as a kinase inhibitor in pharmacology.

Investigated diseases

Generalized Mantle Cell Lymphoma – Generalized Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a type of white blood cell. It is characterized by the overproduction of abnormal B-cells in the lymph nodes, which can spread to other parts of the body, including the bone marrow, spleen, and gastrointestinal tract. The disease progresses as these abnormal cells accumulate, leading to enlarged lymph nodes and potentially affecting the function of various organs. Symptoms may include fatigue, fever, night sweats, and weight loss. As the disease advances, it can cause complications due to the impaired immune system and organ involvement. The progression of the disease can vary, with periods of stability followed by more aggressive phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511235-10-00Protocol codeTRIANGLEEstimated enrolment870 patientsSponsorKlinikum Der Universitat Munchen AöR

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