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Study Comparing Pirtobrutinib with Idelalisib and Rituximab or Bendamustine and Rituximab for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic 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 blood cancer known as Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study is comparing the effectiveness of a new treatment called pirtobrutinib (also known by its code name LY3527727) against other treatment options chosen by doctors. These options include a combination of idelalisib and rituximab, or bendamustine and rituximab. The purpose of the study is to see how well these treatments work in patients who have already been treated with a type of medication called a BTK inhibitor.

Participants in the study will be randomly assigned to one of two groups. One group will receive pirtobrutinib as a single treatment, while the other group will receive one of the doctor-chosen combinations. The study will monitor the participants over a period to see how long they can live without the disease getting worse, which is known as progression-free survival. The treatments will be given in different forms, such as tablets taken by mouth or solutions given through a vein.

The study aims to provide valuable information about the effectiveness of pirtobrutinib compared to existing treatment options for patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This research could help improve future treatment strategies for these conditions. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the treatments' effects.

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, eligibility is confirmed based on specific criteria such as age, kidney function, and previous treatments.

    A signed informed consent form is required, indicating understanding and agreement to comply with study requirements.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: Arm A or Arm B.

    Arm A receives pirtobrutinib as a single treatment.

    Arm B receives a combination of either idelalisib and rituximab or bendamustine and rituximab.

  3. Step 3

    Treatment administration

    In Arm A, pirtobrutinib is taken orally in tablet form.

    In Arm B, idelalisib is taken orally, while rituximab and bendamustine are administered intravenously.

    The specific dosage and frequency are determined by the study protocol and the healthcare team.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess health status and response to treatment.

    Assessments include blood tests, imaging, and other evaluations as required by the study.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to monitor long-term effects and overall health.

    The duration of follow-up is specified by the study protocol.

Who can join the trial?

11 criteria

  • Must be 18 years or older at the time of joining the study.
  • Must have an estimated creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
  • Must be willing and able to give signed informed consent, which means agreeing to the study's rules and requirements.
  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that needs treatment, as defined by specific medical guidelines.
  • Must have been previously treated with a type of medication called a covalent BTK inhibitor.
  • Must have an ECOG performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities.
  • Must have an absolute neutrophil count of at least 0.75 x 109/L without support, or at least 0.50 x 109/L if there is bone marrow involvement. Neutrophils are a type of white blood cell important for fighting infections.
  • Must have a hemoglobin level of at least 8 g/dL, or at least 6 g/dL if there is bone marrow involvement. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Must have a platelet count of at least 50 x 109/L, or at least 75 x 109/L if certain treatments are chosen. Platelets help with blood clotting.
  • Must have AST and ALT levels that are no more than 3 times the upper limit of normal. These are liver 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 during the breakdown of red blood cells.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • LOXO-305

    This is a medication being tested in the trial for its effectiveness in treating chronic lymphocytic leukemia or small lymphocytic lymphoma. It is being used as a single treatment to see how well it works in patients who have already been treated with other BTK inhibitors.

  • Idelalisib

    This medication is used in combination with another drug, rituximab, to treat certain types of blood cancers. In this trial, it is one of the options chosen by the investigator to compare its effectiveness against LOXO-305.

  • Rituximab

    This is a medication that targets specific cells in the immune system and is used to treat various types of blood cancers. In this trial, it is combined with either idelalisib or bendamustine to see how well these combinations work compared to LOXO-305.

  • Bendamustine

    This is a chemotherapy drug used to treat certain types of blood cancers. In this trial, it is combined with rituximab to evaluate its effectiveness against LOXO-305 in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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. It is a new drug in the medical literature, primarily being evaluated for its ability to improve progression-free survival in patients who have previously been treated with BTK inhibitors. Pirtobrutinib works by selectively inhibiting the Bruton's tyrosine kinase (BTK) enzyme, which plays a crucial role in the growth and survival of cancer cells. It is classified as a BTK inhibitor.

  • Idelalisib

    This medication is taken orally and is used in combination with Rituximab for the treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. It is well-documented in medical literature and is used when other treatments have not been effective. Idelalisib works by inhibiting the phosphoinositide 3-kinase delta (PI3Kδ) enzyme, which is involved in the growth and survival of cancer cells. It is classified as a PI3K inhibitor.

  • Bendamustine

    This medication is administered intravenously and is used in combination with Rituximab for treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. It is an established treatment in medical literature, often used when other therapies have failed. Bendamustine works by damaging the DNA in cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent.

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 white blood cells. These cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. The abnormal cells can also spread to other parts of the body, such as the liver and spleen.

  • Small Lymphocytic Lymphoma

    This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to chronic lymphocytic leukemia, with the main difference being the location of the cancerous cells. In small lymphocytic lymphoma, the abnormal cells are mainly found in the lymph nodes rather than the blood and bone marrow. The disease typically progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. Over time, it can affect other organs and tissues, leading to further complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507697-40-00Protocol codeLOXO-BTK-20020Estimated enrolment258 patientsSponsorLoxo Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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