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Study on Venetoclax and Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia

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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 the effects of a treatment for Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The treatment being tested involves a combination of two medications: Venetoclax and Obinutuzumab. Venetoclax, also known by its code name ABT-199, is a small molecule that targets a specific protein in cancer cells, while Obinutuzumab is a type of medication called an antibody, which helps the immune system to attack cancer cells.

The purpose of this study is to evaluate how effective and safe this combination treatment is for patients whose CLL has returned after previous treatment. Participants in the study will receive Venetoclax in the form of a film-coated tablet taken orally, and Obinutuzumab as a solution for infusion, which means it is given directly into a vein. The study will follow participants over a period of time to monitor changes in their disease and any side effects they may experience.

Throughout the study, participants will be assessed to see how their disease responds to the treatment. The study aims to understand the overall response rate, which is the proportion of participants who show improvement in their condition. Other aspects being evaluated include how long it takes for the treatment to start working, how long the response lasts, and the time until any further treatment is needed. The study will also look at progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time a patient lives after starting the treatment.

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

    Initiation of treatment

    The treatment begins with the administration of obinutuzumab through an intravenous infusion. This is a solution that is delivered directly into the bloodstream.

    The infusion is given in a healthcare setting under the supervision of medical professionals.

  2. Step 2

    Oral medication phase

    Following the initial infusion, venetoclax is introduced. This medication is taken orally in the form of film-coated tablets.

    The dosage of venetoclax is gradually increased over a period of time to reach the target dose. This process is known as dose ramp-up and is designed to minimize side effects.

  3. Step 3

    Combination treatment

    The treatment continues with a combination of oral venetoclax and intravenous obinutuzumab.

    This phase aims to maximize the effectiveness of the treatment by using both medications together.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment, regular assessments are conducted to monitor the response to the medications.

    These assessments include blood tests and other evaluations to determine the overall response rate, which is the proportion of patients achieving a significant reduction in disease activity.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment cycle, a comprehensive evaluation is performed to assess the overall response and any changes in disease activity.

    The primary goal is to determine the effectiveness of the treatment in achieving a complete or partial response.

  6. Step 6

    Follow-up period

    After the treatment cycle is completed, a follow-up period is initiated to monitor the duration of the response and any potential progression of the disease.

    This period includes regular check-ups and assessments to ensure ongoing health and well-being.

Who can join the trial?

10 criteria

  • You must sign a form agreeing to participate in the study. This form is approved by an independent committee to ensure your rights are protected.
  • You must not be in prison and must be able to give your consent freely. This means you should not be under legal protection or unable to express your consent.
  • You need to have a confirmed diagnosis of **chronic lymphocytic leukemia (CLL)** that requires retreatment. CLL is a type of cancer that affects the blood and bone marrow.
  • You should have previously completed a treatment with **venetoclax** and an **anti-CD20 antibody** as your first treatment and shown a positive response. This means your disease improved with the treatment.
  • You should not be receiving any approved second-line therapies, based on your and your doctor's decision.
  • If you are in Cohort 1, more than 24 months should have passed since your last dose of venetoclax before needing treatment again. If you are in Cohort 2, it should be between 12 to 24 months.
  • You should not have received any other treatment for CLL after completing your previous treatment with venetoclax and anti-CD20 antibody.
  • You should not have stopped your previous venetoclax treatment because your disease got worse during the treatment.
  • You should not have active or uncontrolled **autoimmune hemolytic anemia** or **immune thrombocytopenic purpura**. These are conditions where your immune system attacks your own blood cells.
  • Your CLL should not have changed into a more aggressive form of cancer, like **Richter's transformation** or **pro-lymphocytic leukemia**.
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Investigated drugs

  • Venetoclax

    is a medication used in this trial to treat patients with recurring chronic lymphocytic leukemia. It works by helping to kill cancer cells and is often used in combination with other treatments to improve its effectiveness.

  • Obinutuzumab

    is another medication involved in the trial. It is an antibody therapy that targets specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is used alongside Venetoclax to enhance the treatment's overall impact on the leukemia.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally in tablet form. It is currently used in the treatment of chronic lymphocytic leukemia, particularly in cases where the disease has recurred. The medication works by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor and is well-documented in medical literature for its effectiveness in treating certain types of leukemia.

  • Obinutuzumab

    Obinutuzumab is administered intravenously, typically in a clinical setting. It is used in the treatment of chronic lymphocytic leukemia, especially when the disease returns after initial treatment. The drug targets a protein called CD20 found on the surface of certain blood cells, leading to the destruction of these cells. Obinutuzumab is classified as a monoclonal antibody and is recognized in medical literature for its role in treating blood cancers.

Investigated diseases

Chronic Lymphocytic Leukemia Recurrent – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells called lymphocytes. In its recurrent form, the disease returns after a period of improvement or remission. It typically progresses slowly, with symptoms that may include swollen lymph nodes, fatigue, fever, and weight loss. Over time, the abnormal lymphocytes can crowd out healthy blood cells, leading to complications such as anemia and increased risk of infections. The disease's progression can vary greatly among individuals, with some experiencing rapid changes while others have a more indolent course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504599-10-00Protocol codeM20-356Estimated enrolment75 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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