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Study on Bendamustine, Obinutuzumab, Zanubrutinib, and Venetoclax for Patients with Relapsed Chronic Lymphocytic Leukemia

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 treatment for chronic lymphocytic leukemia (CLL), specifically for patients whose disease has returned or is not responding to previous treatments. The study involves a sequence of medications starting with bendamustine, followed by a combination of obinutuzumab, zanubrutinib (also known as BGB-3111), and venetoclax (also known as ABT-199). These medications are used to target and treat CLL, with the aim of evaluating their effectiveness and safety in managing the disease.

The purpose of the study is to assess how well this treatment sequence works in reducing the presence of cancer cells in the blood. Participants will first receive two cycles of bendamustine, which is an antitumor agent given through an infusion into a vein. This is followed by a combination therapy involving obinutuzumab, a protein-based drug also given by infusion, and zanubrutinib and venetoclax, which are taken orally as capsules or tablets. The study will monitor the response to these treatments over a period of time to determine their impact on the disease.

Throughout the study, participants will undergo regular assessments to track their response to the treatment. These assessments will help determine the overall response rate, which includes complete or partial responses to the therapy. The study will also monitor the safety of the treatment by recording any side effects or adverse events experienced by participants. The ultimate goal is to understand the potential benefits and risks of this treatment approach for patients with relapsed or refractory CLL.

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 initial phase involves the administration of bendamustine hydrochloride. This medication is given through an intravenous infusion. The treatment consists of two cycles, each lasting for a specified period, to help manage chronic lymphocytic leukemia (CLL).

  2. Step 2

    Combination therapy phase

    Following the initial treatment, a combination therapy is introduced. This includes obinutuzumab, administered as an intravenous infusion, zanubrutinib in capsule form, and venetoclax in film-coated tablet form. The combination aims to enhance the treatment's effectiveness against CLL.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes measuring the minimal residual disease (MRD) in the blood using flow cytometry. The goal is to evaluate the reduction of cancer cells and adjust the treatment plan as necessary.

  4. Step 4

    Maintenance phase

    If the treatment shows a positive response, a maintenance phase may be initiated. This phase involves continued administration of the medications to sustain the treatment's benefits and prevent relapse.

  5. Step 5

    Follow-up

    After completing the treatment phases, follow-up assessments are conducted to monitor long-term outcomes. These assessments help determine the overall effectiveness of the treatment and the patient's progression-free survival.

Who can join the trial?

14 criteria

  • The patient must have **relapsed/refractory chronic lymphocytic leukemia (CLL)** that needs treatment. This means the leukemia has returned or is not responding to treatment.
  • If the patient had recent treatment, they must have recovered from any immediate side effects. The previous treatment must have stopped for a certain time before starting the study:
    • At least 28 days for chemotherapy
    • At least 14 days for antibody treatment
    • At least 3 days for kinase inhibitors, BCL2-antagonists, or immuno-modulatory agents
    • **Corticosteroids** can be used until the study treatment starts, but must be reduced to 20mg or less of prednisolone per day during the study.
    • Patients who had disease progression during treatment with certain drugs like venetoclax or ibrutinib, or have a known resistance mutation, cannot participate. However, those who progressed after stopping these treatments or stopped due to intolerance can participate.
    • The patient must have **adequate kidney function**, which means their kidneys are working well enough, as shown by a creatinine clearance of 30ml/min or more.
    • The patient must have **adequate blood function**, meaning enough white blood cells, hemoglobin, and platelets, unless these are low due to CLL.
    • The patient must have **adequate liver function**, meaning their liver is working well enough, as shown by certain blood tests.
    • The patient must test negative for **hepatitis B**, **hepatitis C**, and **HIV**. If they have had hepatitis B in the past, they can participate if certain tests are negative and are monitored regularly.
    • The patient must be **18 years or older**.
    • The patient must have an **ECOG performance status** of 0 to 2, which is a scale that measures how well they can perform daily activities. A score of 3 is allowed if it is due to CLL.
    • The patient must have a **life expectancy of at least 6 months**.
    • The patient must be able and willing to provide **written informed consent** and follow the study schedule and requirements.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than chronic lymphocytic leukemia that has come back or is not responding to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy or severe reaction to any of the study medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain heart conditions that could be affected by the study treatment.
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Investigated drugs

  • Bendamustine

    is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL) that has returned or is resistant to previous treatments. It works by interfering with the growth of cancer cells, which are eventually destroyed.

  • Obinutuzumab

    , also known as GA101, is an antibody therapy used in this trial. It targets a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

  • Zanubrutinib

    , also referred to as BGB-3111, is a medication that blocks a protein involved in the growth and survival of cancer cells. By inhibiting this protein, zanubrutinib helps to slow down or stop the progression of the disease.

  • Venetoclax

    , also known as ABT-199, is a medication that helps to kill cancer cells by blocking a protein that prevents cell death. This allows the cancer cells to die naturally, reducing the number of cancer cells in the body.

What is already known about the treatment

  • Bendamustine

    Bendamustine is administered intravenously and is currently used in clinical trials for treating relapsed or refractory chronic lymphocytic leukemia (CLL). It is a chemotherapy drug that works by damaging the DNA in cancer cells, which prevents them from dividing and growing. Bendamustine is classified as an alkylating agent and is often used in combination with other medications to enhance its effectiveness.

  • Obinutuzumab

    Obinutuzumab is given as an intravenous infusion and is being studied for its effectiveness in treating relapsed or refractory CLL. It is a monoclonal antibody that targets a specific protein on the surface of cancer cells, leading to their destruction by the immune system. Obinutuzumab is classified as an anti-CD20 monoclonal antibody and is used in combination with other therapies to improve patient outcomes.

  • Zanubrutinib

    Zanubrutinib is taken orally and is part of ongoing research for treating relapsed or refractory CLL. It works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. Zanubrutinib is classified as a BTK inhibitor and is used to disrupt the signaling pathways that promote cancer cell proliferation.

  • Venetoclax

    Venetoclax is administered orally and is being evaluated for its role in treating relapsed or refractory CLL. It functions by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax induces cancer cell death. It is classified as a BCL-2 inhibitor and is often used in combination with other treatments to enhance its therapeutic effects.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic lymphocytic leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal white blood cells called lymphocytes. These cells crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. In relapsed or refractory cases, the disease returns or does not respond to initial treatment. Over time, CLL can lead to complications like anemia and increased risk of infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502201-16-00Protocol codeCLL2-BZAGEstimated enrolment42 patientsSponsorUniversity Of Cologne

sourced from the EU Clinical Trials Register and site verification

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