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Study Comparing Venetoclax and Obinutuzumab with Drug Combination for Fit Patients with Untreated Chronic Lymphocytic Leukemia Without Specific Genetic Mutations

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 clinical trial is focused on studying a type of blood cancer called Chronic Lymphocytic Leukemia (CLL). The study aims to compare the effectiveness and safety of two different treatment combinations for patients with CLL who have not received treatment before. The first combination includes the medications venetoclax (also known as Venclexta or Venclyxto) and obinutuzumab (also known as Gazyva or Gazyvaro). The second combination involves the use of fludarabine, cyclophosphamide, and rituximab (FCR) or bendamustine and rituximab (BR). The study is specifically for patients with CLL who do not have certain genetic changes known as DEL(17P) or TP53 mutation.

The purpose of the study is to evaluate how well these treatment combinations work in reducing the amount of cancer cells in the blood, which is referred to as the minimal residual disease (MRD) response rate. Participants in the study will receive one of the treatment combinations and will be monitored over a period of time to assess the effectiveness of the treatment. The study will also look at other outcomes such as progression-free survival, overall survival, and the impact of the treatments on quality of life.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the response of their cancer to the treatment. The study will help determine which treatment combination is more effective and safer for patients with previously untreated CLL. This information could be valuable in guiding future treatment decisions for this type of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatment history for chronic lymphocytic leukemia (CLL).

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups. One group receives a combination of venetoclax and obinutuzumab, while the other group receives a regimen of fludarabine, cyclophosphamide, and rituximab or bendamustine and rituximab.

  3. Step 3

    Treatment administration

    For the venetoclax and obinutuzumab group, venetoclax is taken orally as a film-coated tablet, and obinutuzumab is administered via intravenous infusion.

    For the fludarabine, cyclophosphamide, and rituximab or bendamustine and rituximab group, medications are administered through intravenous infusion.

  4. Step 4

    Treatment duration

    The treatment duration varies depending on the assigned group and specific protocol requirements. Regular monitoring and assessments are conducted throughout the treatment period.

  5. Step 5

    Monitoring and assessments

    Participants undergo regular monitoring to assess the response to treatment. This includes blood tests and other evaluations to measure the minimal residual disease (MRD) response rate and other health indicators.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to determine the overall response to the treatment regimen. This includes assessing progression-free survival and other health outcomes.

  7. Step 7

    Follow-up

    Participants may be required to attend follow-up visits to monitor long-term health outcomes and any potential side effects from the treatment.

Who can join the trial?

8 criteria

  • Must be 18 years or older.
  • Must have Chronic Lymphocytic Leukemia (CLL) that has not been treated before, as per specific medical guidelines.
  • Must have a cumulative illness rating scale score of 6 or less. This is a way to measure overall health considering other illnesses.
  • Must have a creatinine clearance of 70 mL/min or more. This is a measure of how well the kidneys are working.
  • Must have certain blood values within specific limits, unless low blood counts are due to CLL:
    • Absolute neutrophil count of 1.0 x 109/L or more, unless the bone marrow is affected.
    • Platelet count of 75 x 109/L or more, and more than 7 days since the last blood transfusion, or 30 x 109/L if the bone marrow is affected.
    • Must have adequate liver function, shown by certain liver tests being no more than twice the normal limit, unless the CLL is causing the changes.
    • Must have a life expectancy of more than 6 months.

Who cannot join the trial?

10 criteria

  • Patients who have had a different type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have a serious infection that needs treatment with antibiotics, antifungals, or antivirals.
  • Patients who have a history of severe allergic reactions to any of the drugs used in the study.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a condition called **autoimmune disease**, where the body's immune system attacks its own healthy cells.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of heart problems, such as a heart attack or heart failure.
  • Patients who have a condition called **HIV**, which affects the immune system.
  • Patients who have **hepatitis B** or **hepatitis C**, which are infections that affect the liver.
  • Patients who are currently participating in another clinical trial.
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Investigated drugs

  • Venetoclax

    This medication is used to treat chronic lymphocytic leukemia (CLL). It works by targeting and inhibiting a specific protein in cancer cells, which helps to kill these cells and slow down the progression of the disease.

  • Obinutuzumab

    This is a type of medication known as a monoclonal antibody. It is used in the treatment of CLL by attaching to cancer cells and helping the immune system to destroy them.

  • Fludarabine

    This medication is a chemotherapy drug used to treat CLL. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Cyclophosphamide

    This is another chemotherapy drug used in the treatment of CLL. It works by damaging the DNA of cancer cells, which stops them from multiplying.

  • Rituximab

    This medication is a monoclonal antibody used to treat CLL. It targets specific proteins on the surface of cancer cells, marking them for destruction by the immune system.

  • Bendamustine

    This is a chemotherapy drug used to treat CLL. It works by damaging the DNA in cancer cells, which prevents them from growing and dividing.

What is already known about the treatment

  • Venetoclax

    This medication is administered orally and is currently being studied in combination with obinutuzumab for the treatment of Chronic Lymphocytic Leukemia (CLL). It is approved for use in certain types of leukemia and is well-documented in medical literature. Venetoclax works by inhibiting a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor and is used primarily for its ability to target and kill cancer cells in blood cancers.

  • Obinutuzumab

    This medication is given as an intravenous infusion and is being evaluated in combination with venetoclax for the treatment of Chronic Lymphocytic Leukemia (CLL). It is an established treatment in the medical community and is used to target specific cancer cells. Obinutuzumab is a monoclonal antibody that binds to the CD20 protein on the surface of B cells, leading to their destruction. It is classified as an anti-CD20 monoclonal antibody and is used to treat certain types of blood cancers by targeting and eliminating cancerous B cells.

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 lymphocytes, a type of white blood cell. 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 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504036-17-00Protocol codeCO41685Estimated enrolment166 patientsSponsorF. Hoffmann-La Roche AG

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