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Study of pirtobrutinib combined with immuno-chemotherapy for previously untreated patients with symptomatic chronic lymphocytic leukemia

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 study focuses on chronic lymphocytic leukemia, a type of cancer that affects the blood and bone marrow. The study is specifically for patients who have not received any previous treatment for this condition and who are experiencing symptoms related to their disease. The treatment being tested is pirtobrutinib, which is a medication that blocks certain proteins involved in cancer cell growth. This medication will be given in combination with a short course of immuno-chemotherapy, which means a mix of drugs that help the immune system fight cancer cells and drugs that directly kill cancer cells. The purpose of the study is to evaluate how well this combination treatment works when given for a fixed period of time.

During the study, participants will receive pirtobrutinib as a film-coated tablet taken by mouth along with the immuno-chemotherapy treatment. The medication will be given according to a specific schedule, with the maximum daily dose being 200 mg. The treatment period can last up to 420 days, which is approximately 14 months. Throughout the study, doctors will monitor how well the treatment is working by checking for the presence of cancer cells in the blood and bone marrow at different time points, including at 9 months, 18 months, and 24 months after starting treatment.

The study will track several important measures over time, including how long patients remain free from disease progression, how long they survive overall, and how long it takes before they need another treatment. Participants will need to attend regular study visits for evaluations and monitoring. The study requires that participants be at least 18 years old, have adequate blood counts and organ function, and be able to take oral medications. Patients must also have received vaccination against SARS-CoV-2 and will need testing before each treatment cycle if clinically indicated.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase with pirtobrutinib

    Treatment will begin with pirtobrutinib, which is taken by mouth. This medication targets specific proteins in the blood cancer cells.

    The medication will be combined with a short course of immuno-chemotherapy, which uses both immune system-based drugs and traditional cancer-fighting medications.

    This treatment is designed to have a fixed duration, meaning it will not continue indefinitely but will last for a predetermined period.

  2. Step 2

    Regular monitoring visits

    Throughout the treatment, regular visits will be scheduled to monitor progress and check for any side effects.

    Before each treatment cycle, a SARS-CoV-2 PCR test may be required if clinically indicated to ensure it is safe to continue treatment.

    Blood samples will be taken to check for minimal residual disease, which means looking for very small amounts of cancer cells that may remain in the blood.

  3. Step 3

    Assessment at month 9

    At 9 months after starting treatment, a blood test will be performed to measure minimal residual disease in peripheral blood.

    This test helps determine how well the treatment is working by detecting any remaining cancer cells in the bloodstream.

  4. Step 4

    Assessment at month 18

    At 18 months after starting treatment, another blood test will be conducted to check for minimal residual disease in peripheral blood.

    This continued monitoring helps track the long-term effectiveness of the treatment.

  5. Step 5

    Comprehensive assessment at month 24

    At 24 months (2 years) after starting treatment, both blood and bone marrow tests will be performed.

    The blood test will check for undetectable minimal residual disease, meaning the goal is to find no cancer cells at a very sensitive level of detection (less than 1 in 10,000 cells).

    A bone marrow sample will also be taken to check for any remaining cancer cells in the bone marrow, where blood cells are produced.

    This comprehensive evaluation will determine the overall success of the treatment.

  6. Step 6

    Long-term follow-up

    After completing the active treatment phase, regular follow-up visits will continue to monitor overall health and check for any signs of disease returning.

    These visits will track important outcomes including progression-free survival (time without the disease worsening), overall survival, and time to next treatment (if needed).

    The total duration of participation in this study, including follow-up, is expected to extend until December 2031.

Who can join the trial?

16 criteria

  • You must be 18 years of age or older at the time of screening
  • You must have chronic lymphocytic leukemia, which is a type of blood cancer affecting white blood cells, confirmed by special laboratory tests according to international guidelines from 2018
  • Your chronic lymphocytic leukemia must not have been treated before and must be causing symptoms
  • Your disease must be at an advanced stage or at an earlier stage but showing signs that it is getting worse and needs treatment, based on international guidelines from 2018
  • Your cancer cells must not have a specific genetic change called Del(17p) or a mutation in a gene called TP53
  • Your blood cell counts must meet certain minimum levels: your neutrophils, which are infection-fighting white blood cells, must be at least 0.75 x 10^9 per liter; your platelets, which help blood clot, must be at least 50 x 10^9 per liter; and your hemoglobin, which carries oxygen in red blood cells, must be at least 80 grams per liter
  • You must have received vaccination against COVID-19 and, if needed for medical reasons, have a negative COVID-19 test before starting each treatment cycle
  • You must be able to swallow and take medications by mouth
  • Your general health and ability to perform daily activities must be good to moderate, rated 0 to 2 on a scale called ECOG performance status, where 0 means fully active and 2 means able to care for yourself but unable to work
  • Your overall health conditions and illnesses must score 6 or less on a scale called CIRS, which measures the severity of other medical problems you may have
  • Your blood clotting function must be adequate, with clotting time tests not greater than 1.5 times the upper normal limit
  • Your kidney function must be adequate, with a creatinine clearance, which measures how well your kidneys filter waste, of at least 30 milliliters per minute
  • Your liver function must be adequate: liver enzymes called AST and ALT must be no more than 3 times the upper normal limit, or no more than 5 times if your liver is affected by the disease; and bilirubin, a substance produced when red blood cells break down, must be no more than 1.5 times the upper normal limit, or no more than 3 times if your liver is affected or you have a condition called Gilbert's Disease
  • You must be willing and able to participate in all required study visits and procedures
  • You must be able to understand the purpose and risks of the study
  • You must sign an informed consent form, which is a document showing you agree to participate after understanding the study

Who cannot join the trial?

3 criteria

  • The study does not list specific exclusion criteria, which are reasons why someone cannot take part in the research.
  • You should discuss with the study doctor whether you are suitable to participate, as they will review your complete medical history and current health condition.
  • General safety checks will be performed to make sure the study is appropriate for you.
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Investigated drugs

  • Pirtobrutinib

    is a targeted therapy medication that works by blocking certain proteins in cancer cells to help stop them from growing and multiplying. In this trial, it is being tested in combination with other treatments for chronic lymphocytic leukemia.

  • Immuno-chemotherapy

    is a combination treatment that uses both immunotherapy and chemotherapy together. Immunotherapy helps your body's immune system fight the cancer cells, while chemotherapy uses drugs to kill or slow the growth of cancer cells. In this study, this combination treatment is given for a short period of time along with pirtobrutinib.

What is already known about the treatment

Pirtobrutinib – Pirtobrutinib is an oral medication that belongs to a class of drugs called BTK inhibitors, which work by blocking a specific protein called Bruton's tyrosine kinase that helps cancer cells grow and survive. This medicine is being studied in clinical trials for the treatment of chronic lymphocytic leukemia, a type of blood cancer that affects white blood cells. In this particular study, pirtobrutinib is being combined with immunotherapy and chemotherapy to test if a shorter treatment period can effectively control the disease in patients who have not received prior treatment. The drug is taken by mouth and works at the cellular level by preventing cancer cells from multiplying and spreading throughout the body.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It occurs when the body produces too many abnormal white blood cells called lymphocytes. These abnormal cells build up in the blood, bone marrow, and lymph nodes over time. The disease typically develops slowly and many people do not have symptoms in the early stages. As the condition progresses, patients may experience swollen lymph nodes, fatigue, frequent infections, and weight loss. The abnormal cells gradually crowd out healthy blood cells, which can lead to problems with the immune system and blood function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521199-80-00Protocol codeFILOCLL016-PACIFICEstimated enrolment82 patientsSponsorFrench Innovative Leukemia Organization (F.I.L.O.).

sourced from the EU Clinical Trials Register and site verification

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