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Study on Obinutuzumab and Venetoclax for Elderly Patients with Chronic Lymphocytic Leukemia Unfit for Standard Treatments

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 Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study is testing a treatment that involves a combination of two medications: Gazyvaro (also known as obinutuzumab) and Venetoclax (also referred to by its code name ABT-199). Gazyvaro is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Venetoclax is taken orally as a tablet.

The purpose of the study is to evaluate the effectiveness and safety of these medications when used together in a specific sequence. Initially, patients will receive Gazyvaro alone, followed by a combination of Gazyvaro and Venetoclax, and then Venetoclax by itself. The study aims to determine if this treatment can help patients with CLL who are not suitable for more intensive treatments. The trial will also explore different ways of continuing Venetoclax treatment, either as a standard maintenance therapy or guided by specific markers in the body.

Participants in the study will undergo a series of treatment cycles over a period of time, with regular monitoring to assess their response to the treatment. The study will look at various outcomes, including the absence of cancer cells in the bone marrow and the overall health and quality of life of the participants. The trial is designed to provide valuable information on how these medications can be used effectively in treating CLL.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Pre-induction phase

    The initial phase involves the administration of Gazyvaro (obinutuzumab).

    This medication is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

    The purpose of this phase is to prepare the body for the subsequent treatment.

  2. Step 2

    Induction phase

    This phase includes 6 cycles of treatment with both Gazyvaro (obinutuzumab) and Venetoclax.

    Venetoclax is taken orally in the form of film-coated tablets.

    The combination of these medications aims to reduce the presence of cancer cells.

  3. Step 3

    Venetoclax maintenance

    Following the induction phase, the treatment continues with Venetoclax maintenance.

    This involves taking Venetoclax tablets orally.

    The duration of this phase can extend up to 24 cycles, depending on the patient's response to the treatment.

  4. Step 4

    MRD-guided venetoclax maintenance

    An alternative to standard maintenance is the MRD-guided approach.

    MRD stands for minimal residual disease, which refers to the small number of cancer cells that may remain after treatment.

    This approach adjusts the treatment based on the presence of these cells, aiming to achieve a more personalized treatment plan.

Who can join the trial?

12 criteria

  • Must have a diagnosis of **symptomatic CLL** (Chronic Lymphocytic Leukemia) according to specific guidelines.
  • Females of childbearing potential must have a **negative pregnancy test** within 28 days before joining the study.
  • Must provide **written informed consent**, meaning you agree to participate after understanding the study details.
  • Must be able to give informed consent, meaning you understand and agree to the study terms.
  • Must not have had any prior treatment for CLL, except for certain allowed corticoid treatments.
  • Must be older than 18 years and not suitable for certain intense treatments known as FCR-like regimens.
  • Must be able to follow the study visit schedule and meet other study requirements.
  • Must have a **WHO performance status** of 2 or less, which is a measure of your ability to perform daily activities.
  • Must have an **absolute neutrophil count** of at least 1.0 x 109/l and a **platelet count** of at least 50 x 109/l, unless these counts are low due to bone marrow issues.
  • Must have a **creatinine clearance** of at least 45 ml/min, which is a measure of kidney function.
  • Must have a **total bilirubin** level of 1.5 times the upper limit of normal or less, unless due to a condition called Gilbert's syndrome.
  • Must have **transaminases** levels of 3 times the upper limit of normal or less, which are enzymes related to liver function.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than chronic lymphocytic leukemia (a type of blood cancer).
  • Patients who are fit for FCR-like regimens, which are specific types of cancer treatments.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to follow the study procedures or take the study medications.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
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Investigated drugs

  • Gazyvaro (obinutuzumab)

    is a medication used in the trial as a pre-induction treatment. It is an antibody that targets specific cells in the immune system and is used to help control chronic lymphocytic leukemia (CLL) in patients who are not suitable for more aggressive treatments.

  • Venetoclax

    is used in combination with obinutuzumab during the induction phase of the trial. It works by helping to kill cancer cells and is used to treat CLL. After the initial treatment phase, venetoclax is continued either as a standard maintenance therapy or adjusted based on the patient's response to treatment, as guided by minimal residual disease (MRD) levels.

What is already known about the treatment

  • Obinutuzumab

    This medication is administered intravenously and is currently used in clinical trials for chronic lymphocytic leukemia (CLL). It is a monoclonal antibody that targets a specific protein on the surface of certain white blood cells, leading to their destruction. Obinutuzumab is classified as an anti-cancer agent and is being studied for its effectiveness in combination with other treatments for CLL.

  • Venetoclax

    This medication is taken orally and is being evaluated in clinical trials for its use in treating chronic lymphocytic leukemia (CLL). Venetoclax works by inhibiting a protein that helps cancer cells survive, leading to their death. It is classified as a BCL-2 inhibitor and is being studied for its potential to improve outcomes in patients with CLL, especially when used in combination with other therapies.

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 white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system's ability to function properly. The disease often progresses slowly, and many individuals may not experience symptoms for years. As it advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease. Monitoring and regular check-ups are essential to manage the condition effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511048-22-00Protocol codeHO139Estimated enrolment70 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

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