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Study on the Effectiveness of Venetoclax and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia

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 a blood cancer called Chronic Lymphocytic Leukemia (CLL). The trial is testing a combination of two drugs, Venetoclax and Rituximab, to see how effective and safe they are for patients who have not been treated for CLL before. Venetoclax is taken as a tablet by mouth, while Rituximab is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate if this combination of drugs can help achieve a significant reduction in cancer cells in the bone marrow, which is a sign of a good response to treatment. The study will follow patients over a period of time to monitor their response to the treatment, including how long the response lasts and whether the cancer returns. Patients will receive the treatment for a maximum of 25 weeks, and their health will be closely monitored throughout the study.

Participants in the study will be randomly assigned to receive either the combination of Venetoclax and Rituximab or a placebo. The study aims to gather information on the overall effectiveness of the treatment, the quality of life of the participants during the treatment, and any side effects they may experience. The trial will also explore new ways to predict how well patients will respond to the treatment using advanced techniques like machine learning and by studying gut bacteria. The study is expected to continue until 2027.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.
Step 2
Treatment initiation
The treatment begins with the administration of rituximab through an intravenous infusion. This involves receiving the medication directly into the bloodstream via a vein.
Following the infusion, the patient starts taking venetoclax orally. The dosage and frequency are determined by the study protocol and adjusted as needed.
Step 3
Treatment continuation
The patient continues to receive rituximab infusions at specified intervals as outlined in the study protocol.
Oral administration of venetoclax continues daily. The dosage may vary over time based on the patient's response and any side effects experienced.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the patient's response to the treatment. This includes blood tests and other evaluations to check for minimal residual disease (MRD) and overall health status.
The study team may adjust the treatment plan based on these assessments to ensure the best possible outcomes.
Step 5
Completion of treatment
At the end of the treatment period, a final assessment is performed to evaluate the effectiveness of the therapy. This includes checking for undetectable MRD in the bone marrow.
The patient may be asked to continue follow-up visits to monitor long-term health and any delayed effects of the treatment.

Who can join the trial?

16 criteria

Must have signed an Informed Consent Form, which means you agree to participate after understanding the study.
No active hemolytic anemia that needs treatment. This is a condition where red blood cells are destroyed faster than they can be made.
Not currently using corticosteroids, which are a type of medication. Low doses for other conditions are allowed.
No past autoimmune issues since the diagnosis of CLL that needed high-dose corticosteroids or other specific treatments.
No major surgery within 4 weeks or minor surgery within 3 days before starting the study treatment.
No radiation therapy within 4 weeks before starting the study treatment.
Must be able to take medication to prevent tumor lysis syndrome, a condition that can occur when cancer cells break down quickly.
Women who can have children must have a negative pregnancy test and agree to use two forms of birth control or abstain from sex. Men must use a condom during sex with women who can have children.
Must be willing and able to follow the study's requirements.
Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that meets specific criteria.
No previous treatment for CLL or SLL, including chemotherapy or certain other therapies.
Must need treatment according to specific guidelines.
Must have an ECOG performance score of 2 or less, which measures daily living abilities.
Must have adequate blood function without support, meaning certain blood counts must be at specific levels.
Must have adequate kidney function, which is measured by how well your kidneys clear creatinine, a waste product.
Must have adequate liver function, which is measured by specific liver enzymes and bilirubin levels.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer that is not chronic lymphocytic leukemia.
Patients who have had a different cancer treatment within the last 30 days.
Patients with severe heart problems.
Patients with uncontrolled infections.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to the study medication.
Patients with significant liver or kidney disease.
Patients who are unable to follow the study procedures.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Instytut Hematologii I Transfuzjologii
Verified
Warsaw, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

Venetoclax
is a medication used in this trial to treat chronic lymphocytic leukemia (CLL). It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill the cancer cells and slow down the progression of the disease. It is taken orally, meaning you swallow it in the form of a pill.
Rituximab
is another medication used in this trial for treating CLL. It is a type of therapy known as a monoclonal antibody. Rituximab works by attaching to a specific protein found on the surface of cancer cells. This helps the body's immune system recognize and destroy these cancer cells. Rituximab is usually given through an infusion, which means it is administered directly into the bloodstream through a vein.

What is already known about the treatment

Venetoclax
Venetoclax is taken orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating chronic lymphocytic leukemia (CLL). It is known for its ability to target and block a specific protein called BCL-2, which helps cancer cells survive. By inhibiting this protein, venetoclax encourages the cancer cells to die, making it a promising treatment for CLL. It is classified as a BCL-2 inhibitor and is often used in combination with other medications to enhance its therapeutic effects.
Rituximab
Rituximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is a well-established medication in the treatment of chronic lymphocytic leukemia (CLL) and other blood cancers. Rituximab works by targeting a specific protein called CD20 found on the surface of certain cancer cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody and is often used in combination with other drugs to improve treatment outcomes.

Investigated diseases

Chronic lymphocytic leukemia – Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell, in the blood. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. As the disease advances, it may cause anemia and bleeding problems due to the reduced number of healthy blood cells. The progression of chronic lymphocytic leukemia can vary greatly among individuals, with some experiencing a stable condition for years and others having a more aggressive form.