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Study on the Effectiveness and Safety of Pirtobrutinib vs. Ibrutinib for Patients with Previously Treated 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 comparing the effectiveness and safety of a new treatment called LOXO-305, also known by its code name pirtobrutinib, with other standard treatments chosen by doctors. These standard treatments are known as Bruton's tyrosine kinase (BTK) inhibitors, which are a type of medication that helps to block certain proteins that encourage cancer cells to grow.

The purpose of the study is to see how well patients with previously treated Mantle Cell Lymphoma respond to pirtobrutinib compared to other BTK inhibitors. Participants in the study will be randomly assigned to receive either pirtobrutinib or a BTK inhibitor chosen by their doctor. The study will monitor the participants over a period of time to see how long they can live without their disease getting worse, which is known as progression-free survival.

During the study, participants will take the medication in the form of tablets, which are taken by mouth. The study will last for up to 48 weeks, and participants will have regular check-ups to monitor their health and the effects of the treatment. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance. The study aims to provide valuable information on the best 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

    Joining the study

    Upon joining the study, the patient is confirmed to have mantle cell lymphoma and meets specific health criteria, such as adequate kidney function and blood cell counts.

    The patient must have been previously treated with at least one line of therapy for mantle cell lymphoma.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: Arm A or Arm B.

    Arm A receives pirtobrutinib as a single treatment.

    Arm B receives a Bruton’s tyrosine kinase (BTK) inhibitor chosen by the investigator, which could be ibrutinib.

  3. Step 3

    Treatment administration

    The patient takes the assigned medication orally in the form of tablets.

    The dosage and frequency are determined by the study protocol and the investigator's choice for Arm B.

  4. Step 4

    Monitoring and assessments

    The patient's health and response to the treatment are regularly monitored.

    Progression-free survival is assessed according to specific criteria to determine the effectiveness of the treatment.

  5. Step 5

    Completion of the study

    The study is estimated to end by September 30, 2025.

    The patient's participation continues until the study's completion or until the treatment is no longer effective.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL).
  • Must have a creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
  • Must have been treated with at least one previous type of systemic therapy for MCL.
  • Must have measurable disease according to the Lugano criteria, which is a way to assess the size and spread of cancer.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have an absolute neutrophil count of at least 0.75 × 109/L without needing support from medications that stimulate white blood cell production within 7 days of screening.
  • Must have a hemoglobin level of at least 8 g/dL without needing blood transfusions or medications that stimulate red blood cell production within 7 days of screening.
  • Must have a platelet count of at least 50 × 109/L without needing blood transfusions or medications that stimulate platelet production within 7 days of screening.
  • Must have AST and ALT levels that are no more than 3 times the upper limit of normal. These are enzymes that help assess liver function.
  • Must have a total bilirubin level that is no more than 1.5 times the upper limit of normal. Bilirubin is a substance made by the liver.
  • Both male and female participants are eligible.

Who cannot join the trial?

8 criteria

  • Patients who have not been previously treated for Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a type of cancer that affects the lymph nodes.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to provide informed consent, meaning they cannot understand and agree to the study procedures, cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that could make it unsafe for them to take part in the study.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who are currently participating in another clinical trial cannot participate, as this could affect the results of the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period cannot participate, as this could interfere with the study treatment.
  • Patients who have a known allergy or severe reaction to the study medication or similar drugs cannot participate, as this could be harmful.
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Investigated drugs

  • LOXO-305

    This is a medication being tested in the trial for its effectiveness in treating patients with Mantle Cell Lymphoma who have been previously treated but have not received a BTK inhibitor before. It is being studied to see if it can help stop the progression of the disease.

  • Bruton's Tyrosine Kinase (BTK) Inhibitors

    These are a group of medications that work by blocking a specific protein that helps cancer cells grow. In this trial, patients may receive one of these inhibitors as chosen by their doctor. The goal is to see how well these medications work compared to LOXO-305 in controlling the disease.

What is already known about the treatment

Pirtobrutinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, a type of blood cancer. It is in the investigational stage, with ongoing research to determine its benefits and safety. Pirtobrutinib is primarily indicated for patients who have previously been treated for mantle cell lymphoma but have not received a BTK inhibitor. It works by selectively inhibiting Bruton’s tyrosine kinase, a protein that plays a crucial role in the growth and survival of cancer cells. Pirtobrutinib belongs to the pharmacological class of BTK inhibitors, which are designed to block specific pathways that cancer cells use to grow.

Investigated diseases

Mantle Cell Lymphoma – Mantle cell lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that begins in the cells of the immune system. It specifically affects B-cells, a type of white blood cell that helps fight infections. The disease is characterized by the abnormal growth of B-cells in the lymph nodes, spleen, bone marrow, and sometimes other organs. As it progresses, it can lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The disease often spreads to other parts of the body, including the gastrointestinal tract and bone marrow. It is considered a rare form of lymphoma and can vary in how quickly it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507695-52-00Protocol codeLOXO-BTK-20019Estimated enrolment549 patientsSponsorLoxo Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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