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Study on Venetoclax, Obinutuzumab, and Pirtobrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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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 treatments for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), which are types of blood cancers. The study will use three different treatment combinations: Venetoclax with Obinutuzumab, and two variations of Venetoclax with Pirtobrutinib. Venetoclax is a medication that comes in the form of a film-coated tablet, while Obinutuzumab is given as a solution for infusion, meaning it is administered directly into the bloodstream. Pirtobrutinib is also a tablet taken orally.

The purpose of the study is to compare the effectiveness of these treatments in patients who have not received prior treatment for their CLL or SLL. The study will look at how long patients live without their disease getting worse, which is known as progression-free survival. The trial will also explore how the treatment duration can be adjusted based on the measurement of individual residual disease, which refers to the small number of cancer cells that might remain after treatment.

Participants in the study will receive one of the treatment combinations for a set number of cycles. The study will monitor various outcomes, including the overall response to the treatment, the duration of the response, and the time until the next treatment is needed. Safety will also be closely monitored by tracking any adverse events. The study aims to improve treatment outcomes by tailoring the duration of therapy to each patient's needs.

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

    Joining the trial

    Upon joining the trial, the patient will be randomly assigned to one of the treatment groups. This is done to ensure that the study results are unbiased and reliable.

  2. Step 2

    Treatment with venetoclax and obinutuzumab

    In this group, the patient will receive a combination of venetoclax and obinutuzumab. Venetoclax is taken orally as a film-coated tablet. Obinutuzumab is administered intravenously, which means it is given through a vein.

    The treatment lasts for a fixed duration of 12 cycles. Each cycle typically lasts about one month, but the exact schedule will be provided by the healthcare team.

  3. Step 3

    Treatment with venetoclax and pirtobrutinib

    In this group, the patient will receive a combination of venetoclax and pirtobrutinib. Both medications are taken orally as film-coated tablets.

    The treatment lasts for a fixed duration of 15 cycles. Each cycle typically lasts about one month, but the exact schedule will be provided by the healthcare team.

  4. Step 4

    MRD-guided treatment with venetoclax and pirtobrutinib

    In this group, the patient will receive a combination of venetoclax and pirtobrutinib, similar to the previous group. However, the duration of treatment is guided by the measurement of measurable residual disease (MRD). This means that the treatment duration may be adjusted based on the patient's response to the medication.

    The healthcare team will monitor the patient's response and adjust the treatment duration accordingly.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient will have regular check-ups and tests to monitor their health and response to the treatment. This includes measuring the levels of measurable residual disease (MRD) and other health indicators.

    The healthcare team will provide detailed instructions on the schedule and types of tests required.

  6. Step 6

    End of treatment and final assessment

    After completing the treatment cycles, the patient will undergo a final assessment. This includes a comprehensive evaluation of their health and the effectiveness of the treatment.

    The healthcare team will discuss the results and any further steps that may be necessary.

Who can join the trial?

12 criteria

  • Must have a documented diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires treatment.
  • Must have adequate bone marrow function, which means:
    • An absolute neutrophil count (a type of white blood cell) of at least 1 x 109/L.
    • A hemoglobin level (a protein in red blood cells) of at least 8.0 g/dL without needing a blood transfusion in the last 7 days, unless the low level is directly due to CLL/SLL.
    • A platelet count (cells that help with blood clotting) of at least 25 x 109/L, unless the low count is due to CLL/SLL, in which case it should be at least 10,000/µL without a transfusion in the last 7 days.
    • Must have adequate kidney function, shown by a creatinine clearance (a measure of kidney function) of at least 30 ml/min.
    • Must have adequate liver function, which means:
      • Total bilirubin (a substance made by the liver) should be no more than 2 times the normal upper limit, unless due to CLL/SLL or Gilbert's Syndrome.
      • AST/ALT (liver enzymes) should be no more than 2.5 times the normal upper limit, unless due to CLL/SLL.
      • Must test negative for hepatitis B, hepatitis C, and HIV within 6 weeks before joining the study.
      • Must be at least 18 years old.
      • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status, which is a measure of daily living abilities.
      • Must have a life expectancy of at least 6 months.
      • Must be able and willing to provide written informed consent and follow the study visit schedule and other requirements.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer that is not **chronic lymphocytic leukemia (CLL)** or **small lymphocytic lymphoma (SLL)** cannot participate.
  • Patients who have previously received treatment for **CLL** or **SLL** are not eligible.
  • Patients with severe heart problems, such as heart failure or recent heart attack, are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections that require treatment with antibiotics, antifungals, or antivirals are not allowed.
  • Patients with a history of other serious medical conditions that could interfere with the study are excluded.
  • Pregnant or breastfeeding women cannot participate in the study.
  • Patients who are unable to follow the study procedures or comply with the study requirements are not eligible.
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Investigated drugs

  • Venetoclax

    is a medication used in this trial to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by targeting a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill cancer cells and slow down the progression of the disease.

  • Obinutuzumab

    is another medication used in the trial. It is a type of antibody therapy that targets cancer cells. Obinutuzumab attaches to a specific protein on the surface of cancer cells, marking them for destruction by the body's immune system. This helps to reduce the number of cancer cells in the body.

  • Pirtobrutinib

    is a medication being tested in this trial for its effectiveness in treating CLL and SLL. It works by blocking a protein that is important for the growth and survival of cancer cells. By inhibiting this protein, pirtobrutinib may help to stop the cancer from growing and spreading.

What is already known about the treatment

  • Venetoclax

    Venetoclax is taken orally in the form of tablets and is used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is currently well-established in medical literature as an effective treatment for these conditions. Venetoclax works by targeting a specific protein in cancer cells called BCL-2, which helps the cancer cells survive; by inhibiting this protein, venetoclax promotes the death of these cancer cells. It is classified as a BCL-2 inhibitor, a type of targeted cancer therapy.

  • Obinutuzumab

    Obinutuzumab is administered through an intravenous infusion and is used in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is recognized in medical literature as a valuable treatment option for these conditions. Obinutuzumab works by binding to a protein called CD20 on the surface of cancerous B-cells, leading to the destruction of these cells by the immune system. It is classified as a monoclonal antibody, a type of targeted therapy that helps the immune system fight cancer.

  • Pirtobrutinib

    Pirtobrutinib is taken orally in the form of capsules and is used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is currently being studied in clinical trials to determine its effectiveness and safety. Pirtobrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells; by blocking this protein, pirtobrutinib helps to stop the growth of cancer cells. It is classified as a BTK inhibitor, a type of targeted cancer therapy.

Investigated diseases

  • Chronic Lymphocytic Leukemia (CLL)

    Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell. These abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. Over time, the disease can cause the spleen and liver to enlarge. As CLL progresses, it may interfere with the production of other blood cells, leading to anemia and increased bleeding. The disease can transform into a more aggressive form of lymphoma in some cases.

  • Small Lymphocytic Lymphoma (SLL)

    Small Lymphocytic Lymphoma 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 cancer cells. In SLL, the cancerous lymphocytes are mainly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly and can lead to symptoms such as painless swelling of the lymph nodes, fatigue, and night sweats. As it advances, SLL can affect other organs and tissues, including the spleen and liver. The disease may eventually transform into a more aggressive form of lymphoma.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510294-34-00Protocol codeCLL18/MOIRAIEstimated enrolment813 patientsSponsorUniversity Of Cologne

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).