Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study Comparing Obinutuzumab and Venetoclax with Obinutuzumab and Chlorambucil for Untreated Chronic Lymphocytic Leukemia Patients with Other Health Conditions

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of blood cancer called Chronic Lymphocytic Leukemia (CLL). The study is comparing the effectiveness and safety of two different treatment combinations for patients who have not received treatment for CLL before and have other medical conditions. The first treatment combination includes Obinutuzumab and Venetoclax, while the second combination includes Obinutuzumab and Chlorambucil. Obinutuzumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while Venetoclax and Chlorambucil are taken as tablets.

The purpose of the study is to determine which treatment combination is more effective in preventing the progression of CLL. Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how well the treatments work in controlling the disease and to observe any side effects. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the overall health and survival of the participants.

Throughout the study, participants will have regular check-ups and tests to assess their health and the status of their CLL. These tests will help the researchers understand how the treatments are working and ensure the safety of the participants. The study aims to provide valuable information that could improve treatment options for people with CLL in the future.

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

    Initial treatment phase

    The treatment begins with the administration of obinutuzumab through an intravenous infusion. This is a solution for infusion and is given to help manage chronic lymphocytic leukemia (CLL).

    During this phase, rasburicase may also be administered intravenously to help manage uric acid levels in the blood.

  2. Step 2

    Oral medication phase

    Following the initial infusions, venetoclax is introduced. This medication is taken orally in the form of film-coated tablets. The dosage and frequency will be determined by the healthcare provider based on individual patient needs.

    In some cases, chlorambucil tablets may be prescribed as an alternative to venetoclax. This is also an oral medication and will be taken according to the schedule provided by the healthcare provider.

  3. Step 3

    Combination treatment phase

    The treatment continues with a combination of obinutuzumab and either venetoclax or chlorambucil. This phase aims to enhance the effectiveness of the treatment by using both intravenous and oral medications.

    The duration of this phase and the specific regimen will be tailored to the patient's response to the treatment and overall health condition.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, regular monitoring will be conducted to assess the patient's response to the treatment. This includes evaluating progression-free survival, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

    Additional assessments may include checking for minimal residual disease (MRD) in the blood and bone marrow, as well as monitoring for any adverse events or side effects.

  5. Step 5

    Completion of treatment

    At the end of the treatment period, a final assessment will be conducted to determine the overall response to the treatment. This includes evaluating the complete response rate and overall survival.

    The healthcare provider will discuss the results and any further steps that may be necessary based on the patient's condition and response to the treatment.

Who can join the trial?

8 criteria

  • The patient must have a documented case of Chronic Lymphocytic Leukemia (CLL) that has not been treated before. CLL is a type of cancer that affects the blood and bone marrow.
  • The CLL must require treatment based on specific guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
  • The patient must have a Total Cumulative Illness Rating Scale (CIRS) score greater than 6. This scale measures the overall health condition of a person, considering other illnesses they might have.
  • The patient must have a creatinine clearance (CrCl) of less than 70 mL/min. Creatinine clearance is a test that measures how well the kidneys are working.
  • The patient must have adequate bone marrow function without needing support from growth factors or blood transfusions within 2 weeks before the screening, unless the low blood cell count is due to CLL affecting the bone marrow.
  • The patient must have adequate liver function, meaning the liver is working well enough.
  • The patient must have a life expectancy of more than 6 months.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

5 criteria

  • Patients who have received previous treatment for Chronic Lymphocytic Leukemia (CLL). This means if you have already been treated for CLL, you cannot participate.
  • Patients with other serious medical conditions that might interfere with the study. This means if you have other health issues that could affect the study results, you may not be eligible.
  • Patients who are pregnant or breastfeeding. This means if you are expecting a baby or nursing, you cannot join the study.
  • Patients who are unable to follow the study procedures. This means if you cannot comply with the study requirements, you may not be able to participate.
  • Patients with a history of severe allergic reactions to the study drugs. This means if you have had serious allergies to the medications being tested, you cannot take part.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Obinutuzumab

    is a medication used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL). It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells.

  • Venetoclax

    is a medication that helps treat chronic lymphocytic leukemia (CLL) by blocking a protein that cancer cells need to survive. This action helps to kill and reduce the number of cancer cells in the body.

  • Chlorambucil

    is a chemotherapy drug used to treat chronic lymphocytic leukemia (CLL). It works by slowing or stopping the growth of cancer cells, helping to control the disease.

What is already known about the treatment

  • Obinutuzumab

    This medication is administered intravenously and is used in the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently being studied in clinical trials to assess its effectiveness and safety when combined with other drugs. Obinutuzumab works by targeting a specific protein on the surface of certain white blood cells, leading to their destruction. It is classified as a monoclonal antibody.

  • Venetoclax

    This medication is taken orally and is used to treat Chronic Lymphocytic Leukemia (CLL). It is being evaluated in clinical trials for its efficacy and safety in combination with other treatments. Venetoclax functions by inhibiting a protein that helps cancer cells survive, leading to their death. It is classified as a BCL-2 inhibitor.

  • Chlorambucil

    This medication is administered orally and is used in the treatment of Chronic Lymphocytic Leukemia (CLL). It is part of ongoing clinical trials to compare its effectiveness and safety in combination with other drugs. Chlorambucil works by interfering with the DNA replication of cancer cells, preventing their growth. It is classified as an alkylating agent.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504034-22-00Protocol codeBO25323Estimated enrolment397 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.