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Efficacy and Safety of Three Different Doses of Pirtobrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Previously Received BTK Inhibitor Treatment

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 study focuses on Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), which are types of blood cancers that affect certain white blood cells. These conditions involve an overproduction of abnormal lymphocytes that accumulate in the blood, bone marrow, and lymphatic tissues. The study evaluates a medication called pirtobrutinib, which is being tested in people whose CLL/SLL has returned or not responded adequately to previous treatments that included a covalent Bruton Tyrosine Kinase inhibitor (a type of medication that blocks specific proteins involved in cancer growth).

The purpose of this research is to compare the effectiveness and safety of three different doses of pirtobrutinib: 60 mg, 120 mg, and 200 mg. Participants in this study will have already undergone between one and three previous treatments for their condition before joining this trial. The medication being studied works by targeting and blocking specific cellular processes that cancer cells use to grow and survive.

This is a Phase 2, open-label, randomized study, which means participants will be randomly assigned to receive one of the three doses of pirtobrutinib, and both the participants and researchers will know which dose is being administered. During the study, participants will take pirtobrutinib orally and will be monitored to assess how they respond to the treatment and any side effects that may occur.

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 and randomization

    You will be randomly assigned to one of three dosage groups of pirtobrutinib: 60 mg, 120 mg, or 200 mg. This is a medication used to treat relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

    This study specifically includes patients who have previously been treated with a covalent Bruton Tyrosine Kinase inhibitor (a type of medication that blocks an enzyme important for cancer cell growth).

  2. Step 2

    Medication administration

    You will take pirtobrutinib tablets orally (by mouth) at your assigned dose (either 60 mg, 120 mg, or 200 mg).

    The medication must be swallowed whole. Your doctor will provide specific instructions on when and how to take the medication.

  3. Step 3

    Treatment period

    You will continue taking the medication until your disease progresses, you experience unacceptable side effects, or until the study ends.

    During this time, you will need to maintain an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2, which measures your ability to perform daily activities and care for yourself.

  4. Step 4

    Regular assessments

    Throughout the study, you will have regular visits to the clinic for monitoring of your condition.

    These visits will include physical examinations, blood tests, and other assessments to evaluate how your body is responding to the treatment.

    The doctors will be measuring the Overall Response Rate, which is how well your cancer responds to the treatment.

  5. Step 5

    End of study

    The study is expected to run until February 2025, with follow-up potentially continuing until June 2028.

    At the end of your participation, you will have a final assessment to evaluate your overall health and the effect of the treatment on your CLL/SLL.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma) according to specific medical criteria.
  • You must have received previous treatment for CLL/SLL.
  • You must have received at least 1, but not more than 3 different treatments (lines of therapy) for your CLL/SLL.
  • You must have previously received a covalent BTK inhibitor (a type of medication that blocks an enzyme called Bruton's tyrosine kinase).
  • You must currently need therapy according to established medical criteria.
  • You must be able to swallow oral medication (pills taken by mouth).
  • You must have an ECOG Performance Status score of 0 to 2 (this measures your ability to perform daily activities, where 0 means you're fully active and 2 means you can do all self-care but are unable to work).

Who cannot join the trial?

12 criteria

  • You have had cancer treatments (chemotherapy, immunotherapy, targeted therapy, or radiation therapy) within the last 3 weeks before starting the study.
  • You have previously taken pirtobrutinib, the medication being studied.
  • You have had a stem cell transplant (a procedure where cells from bone marrow are replaced) within the last 60 days.
  • You have an active serious infection requiring treatment.
  • You have certain heart conditions like significant irregular heartbeat, heart failure, heart attack within the last 6 months, or uncontrolled high blood pressure.
  • You have had a stroke or mini-stroke within the last 6 months.
  • You have active bleeding problems or require blood-thinning medications that cannot be stopped temporarily.
  • You have a known infection with HIV, Hepatitis B, or active Hepatitis C.
  • You have severe liver problems.
  • You have any other serious medical conditions that the study doctor believes would make it unsafe for you to participate.
  • You are pregnant or breastfeeding.
  • You are unwilling to use effective birth control methods during the study if you can become pregnant or father a child.
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Investigated drugs

Pirtobrutinib is a medication being studied for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients whose disease has returned or not responded to previous treatment with a certain type of therapy called a Bruton tyrosine kinase inhibitor. Pirtobrutinib works by blocking a protein in cancer cells that helps them grow and survive.

What is already known about the treatment

Pirtobrutinib – A novel oral medication that belongs to the class of non-covalent Bruton's tyrosine kinase (BTK) inhibitors, used in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by selectively blocking BTK, an enzyme crucial for B-cell development and function, thereby inhibiting the growth and survival of malignant B-cells. Unlike earlier BTK inhibitors, pirtobrutinib forms reversible bonds with its target, potentially offering benefits for patients who have developed resistance to previous BTK inhibitor therapy. The medication is currently being investigated in clinical trials to determine optimal dosing strategies and effectiveness in patients who have failed prior treatments.

Investigated diseases

  • Small Lymphocytic Lymphoma

    Small Lymphocytic Lymphoma (SLL) is a type of non-Hodgkin lymphoma that affects a specific white blood cell called a lymphocyte. It primarily involves the lymph nodes and lymphatic tissue, causing them to enlarge. SLL develops when lymphocytes, specifically B-cells, grow abnormally and accumulate in lymphatic tissues. The disease typically progresses slowly, and many patients remain without symptoms for years. When symptoms do appear, they often include painless swelling of lymph nodes in the neck, armpit, or groin, along with fatigue, night sweats, and unintended weight loss.

  • Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia (CLL) is a slow-growing cancer that affects the blood and bone marrow. It involves the same type of cells as SLL (B-lymphocytes) but primarily affects the blood and bone marrow rather than lymphatic tissue. In CLL, abnormal lymphocytes accumulate in the blood, bone marrow, and lymphatic tissues, crowding out healthy blood cells. The disease often develops gradually, with many patients experiencing no symptoms in early stages. As it progresses, CLL can cause fatigue, enlarged lymph nodes, susceptibility to infections, and easy bruising or bleeding due to low blood cell counts.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2024-515689-15-01Protocol codeJ2N-MC-JZNXEstimated enrolment260 patientsSponsorEli Lilly & Co.

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