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Study of Belimumab with Rituximab and Venetoclax for Patients with Refractory or 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 type of blood cancer called chronic lymphocytic leukemia (CLL), specifically in patients whose disease has returned or not responded to previous treatments. The study is testing a combination of medications to see if they work better together. The medications being used are belimumab, rituximab, and venetoclax. Belimumab is a protein-based drug, while rituximab and venetoclax are already used in treating CLL. The purpose of the study is to find out if adding belimumab to the treatment with rituximab and venetoclax is more effective than using rituximab and venetoclax alone.

Participants in the study will receive these medications through a method called subcutaneous injection, which means the medicine is given under the skin. The study will last for a period of up to 24 months, during which participants will be closely monitored. The researchers will look at how well the cancer responds to the treatment and will also keep track of any side effects that may occur. The study aims to improve understanding of how these medications can be used together to treat CLL more effectively.

Throughout the study, participants will have regular check-ups to assess their health and the progress of the treatment. This includes monitoring the presence of cancer cells in the blood and bone marrow, as well as evaluating overall health and quality of life. The study will also gather information on how the body processes belimumab, which is known as pharmacokinetics. The ultimate goal is to find a more effective treatment option for patients with CLL who have limited options due to the return or resistance of their disease.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written consent is required to participate.

    Eligibility is confirmed based on criteria such as age, health status, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health data. This includes laboratory tests and health evaluations.

    Tests for Hepatitis B, C, and HIV are performed to ensure no active infections are present.

  3. Step 3

    Treatment phase

    The treatment involves the administration of belimumab in combination with rituximab and venetoclax.

    Belimumab is given as a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

    The treatment aims to assess the effectiveness of this combination in managing chronic lymphocytic leukemia.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track the patient's response to treatment. This includes blood tests and health assessments.

    The frequency and severity of any side effects are recorded throughout the treatment period.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is performed to assess the treatment's impact.

    The primary focus is on the negativity rate of minimal residual disease in the blood.

  6. Step 6

    Long-term follow-up

    Patients are followed up every three months during maintenance therapy to monitor long-term outcomes.

    Overall survival and progression-free survival are evaluated, along with quality of life assessments.

Who can join the trial?

10 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have an ECOG score of less than 3. This is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have a diagnosis of CLL/SLL according to specific criteria. CLL stands for chronic lymphocytic leukemia, and SLL stands for small lymphocytic lymphoma.
  • Must have CLL that is either not responding to treatment or has returned after treatment, and it needs treatment again.
  • Must have CLL that has returned after any previous treatment, including radiotherapy, chemotherapy, immunotherapy, or small molecule drugs. If the CLL returned more than 18 months after stopping a drug called venetoclax, the patient can still participate.
  • Must have stopped all treatments for CLL at least 2 weeks before starting the study treatment, except for certain medications used to control symptoms.
  • Any side effects from previous cancer treatments must have improved to a mild level, except for hair loss, nerve damage, or changes in blood cell counts, which can be more severe.
  • Must have certain laboratory test results available within 4 weeks before starting the study treatment.
  • Must have negative tests for Hepatitis B and C, or a negative PCR test if the initial test was positive but there is no active infection. Must also have a negative HIV test within 6 weeks before starting the study treatment.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than chronic lymphocytic leukemia (CLL) cannot participate. CLL is a type of cancer that affects the blood and bone marrow.
  • Patients who have not experienced a return of their CLL after treatment or whose CLL is not resistant to treatment cannot participate. Refractory means the disease does not respond to treatment, and relapsed means the disease has returned after treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible to participate.
  • Patients who are not able to follow the study procedures or who have other medical conditions that might interfere with the study cannot participate.
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Investigated drugs

  • Belimumab

    is a medication used in this trial to help improve the immune system's ability to fight certain types of cancer. It is being tested in combination with other drugs to see if it can enhance their effectiveness in treating chronic lymphocytic leukemia (CLL).

  • Rituximab

    is a medication that targets specific cells in the immune system. It is commonly used to treat certain types of blood cancers, including chronic lymphocytic leukemia. In this trial, it is used in combination with other drugs to evaluate its effectiveness in patients whose cancer has not responded to previous treatments.

  • Venetoclax

    is a medication that helps to kill cancer cells by blocking a protein that allows them to survive. It is used in this trial to see if it can work effectively with other medications to treat chronic lymphocytic leukemia, especially in patients who have not responded to other treatments.

What is already known about the treatment

  • Belimumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating refractory or relapsed chronic lymphocytic leukemia (CLL). It is primarily used to modulate the immune system by inhibiting a protein called B-lymphocyte stimulator (BLyS), which plays a role in the survival of B cells. Belimumab is classified as a monoclonal antibody and is being evaluated for its potential to enhance the efficacy of existing treatments like rituximab and venetoclax.

  • Rituximab

    Administered through intravenous infusion, rituximab is a well-established medication used in the treatment of various types of blood cancers, including chronic lymphocytic leukemia. It works by targeting the CD20 protein found on the surface of B cells, leading to their destruction. Rituximab is classified as a monoclonal antibody and is often used in combination with other drugs to improve treatment outcomes.

  • Venetoclax

    This medication is taken orally and is approved for use in treating chronic lymphocytic leukemia, particularly in cases that are refractory or have relapsed. Venetoclax functions by inhibiting the BCL-2 protein, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor and is frequently used in combination with other therapies to enhance its effectiveness.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic lymphocytic leukemia (CLL) 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, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The condition is often identified during routine blood tests before symptoms appear.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511474-68-00Estimated enrolment120 patientsSponsorUniversitaetsklinikum Tuebingen AöR

sourced from the EU Clinical Trials Register and site verification

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