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Study Comparing Pirtobrutinib and Ibrutinib for 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 two treatments for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of cancer that affect the blood and lymph nodes. The study compares two medications: Pirtobrutinib (also known by its code name LOXO-305) and Ibrutinib. Both medications are taken orally, with Pirtobrutinib in tablet form and Ibrutinib in capsule form.

The purpose of the study is to evaluate how well patients respond to Pirtobrutinib compared to Ibrutinib. Participants in the study will be randomly assigned to receive either Pirtobrutinib or Ibrutinib. The study will monitor the overall response rate, which means it will look at how many patients experience a reduction in their cancer symptoms or achieve remission, where the cancer is no longer detectable. The study is expected to last for a period of up to 66 weeks.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatment. The study aims to provide valuable information on which medication might be more effective for treating CLL and SLL, potentially leading to improved treatment options for patients with these conditions.

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

    Arm A receives pirtobrutinib, and Arm B receives ibrutinib.

  2. Step 2

    Medication administration

    Both pirtobrutinib and ibrutinib are taken orally.

    The specific dosage and frequency of administration are determined by the study protocol and communicated to the patient by the healthcare team.

  3. Step 3

    Treatment duration

    The treatment continues until the study's estimated end date, which is May 1, 2028, unless otherwise specified by the healthcare team.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the patient's response to the treatment.

    The primary goal is to assess the overall response rate, which includes complete remission and partial response.

  5. Step 5

    Completion of the study

    Upon completion of the study, the patient's overall response to the treatment is reviewed.

    Further instructions or follow-up care may be provided based on the patient's condition and response to the treatment.

Who can join the trial?

9 criteria

  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that requires treatment according to specific medical guidelines.
  • Must have an ECOG Performance Status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
  • Must have adequate organ function, which includes:
  • Platelet count of at least 50,000 per microliter of blood, or at least 30,000 if the bone marrow is affected by the disease.
  • Hemoglobin level of at least 8 grams per deciliter, or at least 6 grams if the bone marrow is affected by the disease. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Absolute neutrophil count of at least 0.75 billion per liter, or at least 0.50 billion if the bone marrow is affected by the disease. Neutrophils are a type of white blood cell important for fighting infections.
  • Kidney function with an estimated creatinine clearance of at least 30 milliliters per minute. Creatinine clearance is a measure of how well the kidneys are working.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible.

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 cannot participate.
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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 designed to target specific proteins in cancer cells, potentially slowing down or stopping their growth. In this trial, it is being compared to another medication to see how well it works in improving the overall response rate in patients.

  • Ibrutinib

    is a medication used to treat certain types of cancer, including chronic lymphocytic leukemia and small lymphocytic lymphoma. It works by blocking a protein that helps cancer cells grow and divide. In this study, it is being used as a comparison to evaluate the effectiveness of pirtobrutinib in treating these conditions.

What is already known about the treatment

  • Pirtobrutinib

    Pirtobrutinib 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 medication in the field of oncology, with ongoing research to establish its role in medical practice. The main therapeutic indication is for blood cancers, specifically targeting certain types of leukemia and lymphoma. At the molecular level, pirtobrutinib works by inhibiting a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. It is classified as a kinase inhibitor, a type of targeted cancer therapy.

  • Ibrutinib

    Ibrutinib is an oral medication that is well-established in the treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. It is widely recognized in medical literature and is used to manage these blood cancers. The main therapeutic indication is for treating certain types of leukemia and lymphoma. Ibrutinib functions by blocking Bruton's tyrosine kinase, a protein that helps cancer cells grow and survive. It belongs to the pharmacological class of kinase inhibitors, which are designed to target specific pathways in cancer cells.

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 fatigue, infections, and swollen lymph nodes. As the disease advances, it can affect the body's ability to fight infections and may cause anemia or bleeding problems.

  • 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, often without symptoms in the early stages. Over time, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. As it advances, it may affect other organs and tissues, impacting overall health.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507699-38-00Protocol codeLOXO-BTK-20030Estimated enrolment739 patientsSponsorLoxo Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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