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Study of Pirtobrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

Verified siteInvestigationalNo 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 new drug called pirtobrutinib (also known by its code name LY3527727) in patients who have been previously treated for certain types of blood cancers. These cancers include Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Non-Hodgkin Lymphoma (NHL). The purpose of the study is to explore the safety and effectiveness of pirtobrutinib when used alone or in combination with other medications.

The study is divided into different phases. In the first phase, patients will receive pirtobrutinib by itself to determine the best dose and to observe any side effects. In the second phase, the study will look at how well the drug works in reducing cancer symptoms. Additionally, there is a part of the study where pirtobrutinib is combined with other drugs like venetoclax and rituximab to see if these combinations are safe and effective. Patients will take the medication in the form of a tablet, which is taken by mouth.

Throughout the study, participants will be monitored for any changes in their health, including blood tests and other assessments to ensure their safety. The study aims to gather information on how the drug affects the body and how it interacts with other treatments. This research is important for developing new treatment options for patients with these types of blood cancers.

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, medical history, and current health status.

    Participants must have a confirmed diagnosis of certain types of blood cancers, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma (NHL).

  2. Step 2

    Phase 1: dose determination

    The initial phase involves determining the most suitable dose of the drug pirtobrutinib when taken alone. This is done by gradually increasing the dose to find the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

    Participants take pirtobrutinib orally in tablet form. The frequency and duration of administration are adjusted based on individual tolerance and response.

  3. Step 3

    Phase 1b: combination therapy

    In this phase, the safety of pirtobrutinib is evaluated when combined with other medications, such as venetoclax or rituximab.

    Participants may be assigned to different treatment arms, receiving combinations of these drugs to assess safety and potential interactions.

  4. Step 4

    Phase 2: assessing effectiveness

    The second phase focuses on assessing the effectiveness of pirtobrutinib in treating the specified blood cancers.

    Participants continue to take the medication, and their response to treatment is monitored through various assessments, including imaging and blood tests.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants undergo regular health checks, including physical exams, blood tests, and other necessary evaluations to monitor their health and the effects of the treatment.

    The study is expected to continue until September 2027, with ongoing assessments to ensure participant safety and gather data on the drug's effectiveness.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of a B-cell cancer, such as **Chronic Lymphocytic Leukemia (CLL)**, **Small Lymphocytic Lymphoma (SLL)**, or **Non-Hodgkin Lymphoma (NHL)**, and have tried at least two previous treatments or one treatment with a **BTK inhibitor** if it's approved as the first treatment.
  • For Phase 2, the disease must require treatment. For CLL/SLL, treatment needs are defined by specific guidelines. For NHL, there must be at least one area of the disease that can be measured by scans.
  • Must be at least 18 years old.
  • Must have a tumor sample available from after the most recent treatment.
  • Must have adequate blood clotting ability, meaning certain blood tests should not be more than 1.5 times the normal limit.
  • Must have adequate liver function, with specific liver tests not exceeding certain limits.
  • Must have adequate kidney function, with a creatinine clearance of at least 30 mL/minute.
  • Must have adequate blood cell counts, unless the bone marrow is involved in the disease.
  • Must be able to swallow tablets and attend clinic visits and lab tests as required.
  • Men and women who can have children must agree to use effective birth control during the study and for a period after the study ends. Sperm donation is not allowed during the study and for a month after.
  • Must have a performance status of 0 to 2 on a scale that measures daily living abilities, where 0 means fully active and 2 means unable to work but able to care for oneself.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated for their condition.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with other active cancers that require treatment.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to swallow pills.
  • Patients with certain blood disorders.
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Investigated drugs

  • Pirtobrutinib

    is an oral medication being studied for its effects on patients with previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma. The trial aims to determine the maximum tolerated dose and assess its antitumor activity.

  • Venetoclax

    is a medication used in combination with pirtobrutinib in this study. It is designed to help kill cancer cells by targeting a specific protein that helps them survive.

  • Rituximab

    is another medication used in combination with pirtobrutinib and venetoclax in this trial. It is a type of therapy that targets certain cells in the immune system to help fight cancer.

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 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Non-Hodgkin Lymphoma (NHL). It is in the investigational stage, with ongoing research to determine its maximum tolerated dose and preliminary antitumor activity. Pirtobrutinib works by inhibiting specific proteins involved in the growth and survival of cancer cells, thereby slowing down or stopping the progression of the disease. It is classified as a targeted therapy, specifically a Bruton's tyrosine kinase (BTK) inhibitor.

Investigated diseases

  • Chronic Lymphocytic Leukemia (CLL)

    This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, these abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.

  • Small Lymphocytic Lymphoma (SLL)

    SLL is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to CLL, with the main difference being the location of the cancer cells. In SLL, the cancer cells are mainly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly and may not cause symptoms initially, but over time, it can lead to swollen lymph nodes, fatigue, and other systemic symptoms.

  • Non-Hodgkin Lymphoma (NHL)

    This is a diverse group of blood cancers that include any kind of lymphoma except Hodgkin's lymphomas. NHL can occur at any age and often starts in the lymph nodes, but it can also affect other organs. The progression of NHL varies widely depending on the specific type and can range from slow-growing to aggressive forms. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509270-37-00Protocol codeLOXO-BTK-18001 BRUINEstimated enrolment938 patientsSponsorLoxo Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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