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Study Comparing Pirtobrutinib to Bendamustine and Rituximab for Untreated Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Fast replyRegistered 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 Chronic Lymphocytic Leukemia (CLL) and its closely related condition, Small Lymphocytic Lymphoma (SLL). These are cancers that affect a type of white blood cell called lymphocytes, which are part of the immune system. The study is comparing two different treatments for patients who have not yet received any treatment for their CLL or SLL. One treatment involves a medication called Pirtobrutinib, also known by its code name LOXO-305, which is taken as a tablet by mouth. The other treatment combines two drugs, Bendamustine and Rituximab, which are given through a vein in the arm (intravenous use).

The purpose of the study is to evaluate how well Pirtobrutinib works on its own compared to the combination of Bendamustine and Rituximab. Participants in the study will be randomly assigned to receive either Pirtobrutinib or the combination of Bendamustine and Rituximab. The study will last for a period of time, with Pirtobrutinib being taken for up to 52 weeks, while the combination treatment will be given for up to 6 months. During the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment.

This study is designed to help researchers understand which treatment is more effective in managing Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma in patients who have not been treated before. The information gathered from this study may contribute to better treatment options for these conditions in the future.

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

    Enrollment

    Upon joining the study, the patient is assigned to one of two groups: Arm A or Arm B. This assignment is random and determines the treatment plan.

  2. Step 2

    Treatment initiation

    In Arm A, the patient receives pirtobrutinib as a single treatment. This medication is taken orally. The specific dosage and frequency are determined by the study protocol.

    In Arm B, the patient receives a combination of bendamustine and rituximab. Bendamustine is administered intravenously, while rituximab is also given intravenously. The dosage and schedule are specified in the study protocol.

  3. Step 3

    Treatment duration

    The treatment continues for a period defined by the study protocol. The duration may vary based on the patient's response and any side effects experienced.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the patient's health and response to the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, the patient's condition is assessed to determine the effectiveness of the therapy. Follow-up visits may be scheduled to monitor long-term outcomes.

Who can join the trial?

12 criteria

  • Must be **18 years or older** at the time of joining the study.
  • Must have a confirmed diagnosis of **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)**. This means certain types of white blood cells, called B-cells, must show specific markers like **CD5** and **CD23**.
  • Must need treatment based on specific criteria, such as:
    • Worsening **anemia** (low red blood cells) or **thrombocytopenia** (low platelets).
    • Enlarged or worsening **spleen** or **lymph nodes**.
    • Increasing number of white blood cells over a short period.
    • **Autoimmune** issues not responding well to treatment.
    • Symptoms affecting other body parts like skin or lungs.
    • Symptoms like significant weight loss, severe tiredness, fevers, or night sweats.
    • Must have a performance status of **0 to 2** on the **Eastern Cooperative Oncology Group (ECOG)** scale, which measures daily living abilities.
    • Must have **adequate organ function** based on recent lab tests.
    • Must have completed certain waiting periods after any recent radiation treatments.
    • Women who can have children and their partners must agree to use **effective birth control** methods during the study and for a specified time after the last dose of treatment.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not **Chronic Lymphocytic Leukemia** or **Small Lymphocytic Lymphoma**.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients who have had a major surgery recently.
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Investigated drugs

  • Pirtobrutinib (LOXO-305)

    is a medication being studied for its effectiveness in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It is being tested as a single treatment option to see how well it works in stopping the progression of these diseases.

  • Bendamustine

    is a chemotherapy drug used to treat certain types of cancer, including chronic lymphocytic leukemia. It works by interfering with the growth of cancer cells, which are eventually destroyed.

  • Rituximab

    is a medication that targets specific proteins on the surface of cancer cells. It is used in combination with other drugs to treat certain types of blood cancers, including chronic lymphocytic leukemia. It helps the immune system to identify and attack cancer cells.

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 and Small Lymphocytic Lymphoma. It is a new drug in the medical literature, primarily being evaluated for its potential benefits in these conditions. Pirtobrutinib works by inhibiting a specific enzyme called Bruton's tyrosine kinase, which plays a role in the growth and survival of cancer cells. It is classified as a targeted therapy, aiming to interfere with cancer cell processes at the molecular level.

  • Bendamustine plus Rituximab

    This combination therapy is administered intravenously and is well-established in the treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Bendamustine is a chemotherapy drug that damages the DNA of cancer cells, while Rituximab is a monoclonal antibody that targets a specific protein on the surface of these cells, leading to their destruction. Together, they are classified as an immunochemotherapy regimen, combining the effects of chemotherapy and targeted immune therapy to treat cancer.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    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, the abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. The disease often affects older adults and can be detected through routine blood tests. As it advances, it may cause swollen lymph nodes, fatigue, and weight loss.

  • Small Lymphocytic Lymphoma

    This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the slow accumulation of small, mature lymphocytes in the lymphatic system. The disease progresses gradually and may not present symptoms initially. As it develops, it can lead to enlarged lymph nodes, spleen, or liver, and may cause fatigue and night sweats. It is typically diagnosed in older adults and shares many characteristics with chronic lymphocytic leukemia.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511599-33-00Protocol codeLOXO-BTK-20023Estimated enrolment282 patientsSponsorLoxo Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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